TABLE OF CONTENTS Conference Overview.......................................................................................................... 2 Conference Objectives........................................................................................................ 2 Acknowledgments .............................................................................................................. 5 Conference Committee Members ...................................................................................... 5 NFID Staff............................................................................................................................. 7 Invited Presenters................................................................................................................ 8 Disclosures........................................................................................................................ 10 Continuing Education and Course Evaluation.................................................................... 12 General Information.......................................................................................................... 12 Americans with Disabilities Act............................................................................... 12 Conference Information Desk................................................................................. 12 Conference Language.............................................................................................. 12 Conference Location............................................................................................... 12 Exhibit Hall.............................................................................................................. 12 Green Initiatives...................................................................................................... 13 Meet the Experts..................................................................................................... 13 Messages . .............................................................................................................. 14 No Smoking Policy................................................................................................... 14 Poster Sessions........................................................................................................ 14 Program and Abstracts............................................................................................ 14 Presentations.......................................................................................................... 14 Registration Fees and Hours.................................................................................... 14 Verification of Attendance....................................................................................... 14 Affiliated Events and Other Meetings..................................................................... 14 NFID Luncheon.................................................................................................................. 15 Mary Lou Clements-Mann Memorial Lecture in Vaccine Sciences....................................17 Detailed Program Agenda................................................................................................. 18 Poster Sessions.................................................................................................................. 32 Invited Speaker Biographies.............................................................................................. 38 Abstracts............................................................................................................................ 52 Invited Presentations.............................................................................................. 52 Submitted Oral Presentations................................................................................. 72 Submitted Poster Presentations............................................................................ 102 Travel Grant Posters.............................................................................................. 123 Author Index.................................................................................................................... 131 Notes .............................................................................................................................. 135 NFID Resources................................................................................................................ 145
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The Fifteenth Annual Conference Conference Overview The remarkable growth of vaccine biotechnology continues apace in basic science discovery, product development, market introduction, and adoption into immunization programs. New cytokines are identified, innate and induced immune regulatory pathways unraveled, novel adjuvants and antigen constructs prove effective, and recently-licensed products achieve high coverage, already yielding noticeable decreases in disease incidence. One can envision a growing number of challenging maladies – including chronic, non-infectious, and neoplastic – that may become vaccine-preventable or vaccinetreatable in the years ahead. The Annual Conference on Vaccine Research (ACVR) provides high-quality, up-to-date reports of such scientific progress in its unique mix of invited presentations by acknowledged international experts in symposia of topical interest and its sessions and posters of peer-reviewed submitted abstracts. The ACVR encourages the participation of all the disparate fields of vaccinology in both its human and veterinary domains in order to facilitate valuable cross-fertilization of ideas and approaches among researchers often narrowly focused on their specific diseases or methods. The Fifteenth ACVR aims to maintain its position as the largest scientific meeting devoted exclusively to research on vaccines and associated technologies for disease prevention and treatment through immunization. It is a premier venue for cutting-edge learning, effective data-sharing, and convenient networking for scientific collaboration. The conference organizers and its volunteer committees invite you to participate in the audience discussions, poster presentations, Meet the Expert breakfast sessions, special luncheon lecture, evening reception, and sponsored exhibits, and to provide the helpful feedback essential for further evolution and improvement. Welcome to the Fifteenth ACVR.
Conference Objectives Overall Conference Objectives At the conclusion of this conference, participants should be able to: Discuss recent scientific advances contributing to progress in the development of vaccines Identify research opportunities and scientific challenges associated with vaccine development, production, and distribution
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Symposia Objectives At the conclusion of each symposium, participants should be able to: Keynote Address: Vaccine Discovery – A Varied Process Understand how vaccines are actually developed by examining past and future strategies Symposium 1: Advances in Vaccine Discovery Discuss the recent advances in influenza vaccine discovery, studies towards a universal, long-lasting vaccine, and implementation of live influenza vaccines with universal backbones as a vaccine vector for use in humans and agriculture
on Vaccine Research Discuss the most recent advances in malaria vaccine development as related to technical hurdles, vaccine design, clinical testing, and efficacy testing for down selection of promising lead candidates for later-stage phase three testing Describe the most recent phase three study in sub-Saharan Africa of the malaria vaccine RTS,S, and the challenges ahead Summarize the practical, logistical, and financial challenges faced by the international community as it prepares for the implementation of a licensed malaria vaccine Discuss technological improvements in the DNA vaccine platform improving its ability to drive relevant magnitude and focused immune responses Discuss new approaches to influenza vaccination not dependent upon prediction of circulating virus strains and production of matched vaccines Describe characteristics of the antibody and T cell immunity involved, and types of vaccine candidates with promise for broad cross-protection against influenza infection regardless of subtype Symposium 2: Rotavirus Vaccines Understand the impact of rotavirus vaccines in the US and in low-resource settings Articulate the role of physicians as advocates for rotavirus vaccine in improving the health of patients and populations in their communities around the world Discuss remaining challenges for the use of rotavirus vaccine in low-income countries Describe global rotavirus vaccine use and discuss strategies to maximize the impact of rotavirus vaccines in low-resource settings
Discuss the post-licensure effectiveness and safety data from countries that have adopted routine childhood vaccination against rotavirus Mary Lou Clements–Mann Memorial Lecture in Vaccine Sciences: Introduction of an Affordable Group A Meningococcal Conjugate Vaccine in the African Meningitis Belt Relate the epidemiology of epidemic meningococcal meningitis in Sub-Saharan Africa Explain the importance of herd immunity with conjugate polysaccharide vaccines Understand immunologic responses after polysaccharide and conjugate vaccination Symposium 3: Vaccines for Enteric Diseases Discuss the clinical burden of enteric fever, diagnostic difficulties, and approaches to vaccine prevention Understand the development and utility of a human challenge model of typhoid infection to accelerate the development of typhoid vaccines and the pathophysiology and immunobiology of enteric fever Understand the main populations at risk for diarrhea caused by enterotoxigenic Escherichia coli (ETEC) to inform thinking on policy guidelines and implementation of licensed ETEC vaccines Review the general mechanisms of enterotoxigenic Escherichia coli (ETEC) disease pathogenesis to inform critical evaluation of current vaccine development efforts Recognize the bacterial components implicated as protective antigens for studies of oral passive administration of enterotoxigenic Escherichia coli (ETEC) hyperimmune bovine colostral antibodies to volunteers
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The Fifteenth Annual Conference Review the key features of cholera at the global level Understand the importance of identifying cholera hotspots based on risk assessment Identify the basics of a comprehensive coordinated approach for cholera control Recognize the role cholera vaccines might play as an adjunct measure to routinely recommended cholera prevention and control measures Symposium 4: Food Safety Vaccines Discuss the poultry production system in the US and how Salmonella is transmitted within this food production system Understand the impact of vaccination on reducing Salmonella contamination of eggs and poultry meat Discuss strategies for attenuation of and antigen delivery from recombinant bacterial vaccines to optimize immunogenicity and decrease dosages Review the application of technologies to develop vaccines against infectious diseases of agriculturally important animals, and strategies for attenuation of and antigen delivery from recombinant bacterial vaccines to optimize immunogenicity and decrease dosages Discuss the mechanism of adherence by verotoxigenic E. coli strains in cattle and the development of vaccines which are able to block colonization of cattle by multiple serotypes of the organism in both experimental and field conditions as a means of reducing the risk of human exposure
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Symposium 5: Vaccine Adjuvants Discuss the complex effects of the vaccine adjuvant alum, and discuss the abilities of alum to generate CD8 T cell memory Describe a potentially cross-reactive vaccine against influenza virus Understand the mechanisms underlying alum’s action as a vaccine adjuvant Discuss the emerging role of systems biological approaches in understanding the molecular mechanisms of immune responses to vaccination, uncovering correlates of protective immunity, and predicting the efficacy of vaccines Explain how adjuvants and formulation enhance the magnitude and quality of antibody and T cell immunity when administered with protein vaccines Demonstrate the use of rational design to develop and test defined adjuvant formulations for next generation vaccines Symposium 6: Scientific Assessment of Vaccine Adverse Events Review current data on the pathophysiology of narcolepsy and the occurrence of new onset cases in relation to H1N1 Discuss cases of yellow fever vaccineassociated viscerotropic disease (YEL-AVD) Identify potential risk factors for YEL-AVD Describe current and future initiatives related to YEL-AVD Review the clinical experience collected using squalene-based influenza H1N1/A/09 pandemic vaccines in patients with variable levels of immune competence including HIV-infected patients, solid organ or hematopoietic stem cells transplant recipients, and patients with autoimmune diseases or cancer
on Vaccine Research Acknowledgments (as of April 1, 2012) This conference is supported, in part, through unrestricted educational grants from:
Aeras Global TB Vaccine Foundation BD Diagnostics Crucell Holland B.V CSL Biotherapies Dynavax Technologies Epivax, Inc. Genvec Inovio Pharmaceuticals, Inc.
Ligocyte Pharmaceuticals, Inc. Liquidia Technologies MedImmune, Inc. Merck & Co., Inc. Novartis Vaccines Novavax, Inc. sanofi pasteur US Food and Drug Administration
NFID recognizes the following individuals for their support and contributions in planning this conference:
Gregory A. Poland, MD Conference Co-Chair Conference Organizing and Scientific Program Committees Edward Jenner Society Mayo Clinic and Foundation Rochester, MN
Susan J. Rehm, MD Conference Co-Chair NFID CME, Conference Organizing, and Scientific Program Committees National Foundation for Infectious Diseases Bethesda, MD
Bruce G. Weniger, MD Conference Co-Chair Conference Organizing and Scientific Program Committees Vaccine Chiang Mai University Atlanta, GA
Lorne A. Babiuk, PhD, DSc
Ciro A. de Quadros, MD, MPH
Conference Scientific Program Committee University of Alberta Alberta, Canada
Conference Organizing Committee Sabin Vaccine Institute Washington, DC
Alan D.T. Barrett, PhD
Richard J. Duma, MD, PhD
Conference Organizing Committee Sealy Center for Vaccine Development University of Texas Medical Branch Galveston, TX
Joseph A. Bocchini Jr., MD NFID CME Committee Louisiana State University Shreveport, LA
Conference Scientific Program Committee Halifax Medical Center Daytona Beach, FL
Kathryn M. Edwards, MD NFID CME Committee Vanderbilt University Medical Center Nashville, TN
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The Fifteenth Annual Conference Thomas M. File, Jr., MD, MS
Marguerite Jackson, PhD, RN
NFID CME Committee Summa Health System Akron, OH
NFID CME Committee Jackson Consulting Escondido, CA
Cyril G. Gay, DVM, PhD Conference Organizing and Scientific Program Committees US Department of Agriculture Beltsville, MD
Jeff Goad, PharmD, MPH Conference Organizing Committee American Pharmacists Association Los Angeles, CA
Debra A. Goff, PharmD NFID CME Committee The Ohio State University Medical Center Columbus, OH
Hana Golding, PhD Conference Organizing and Scientific Program Committees Center for Biologics Evaluation and Research US Food and Drug Administration Bethesda, MD
Elizabeth Hermsen, PharmD, MBA, BCPS-ID Conference Organizing Committee Society of Infectious Diseases Pharmacists San Antonio, TX
George C. Hill, PhD NFID CME Committee Vanderbilt University School of Medicine Nashville, TN
Nancy Ivansek, PA-C NFID CME Committee Cleveland Clinic Cleveland, OH
Abdul Jabbar, PhD Conference Organizing Committee Emory Vaccine Center Atlanta, GA
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Paul-Henri Lambert, MD Conference Scientific Program Committee Centre Medical Universitaire de Genéve Geneva, Switzerland
Myron M. Levine, MD, DTPH Conference Organizing and Scientific Program Committees Center for Vaccine Development University of Maryland School of Medicine Baltimore, MD
Christophe Longuet, MD Conference Organizing Committee Fondation Mérieux Lyon, France
Sasha Madison, MPH, CIC NFID CME Committee Stanford Hospital and Clinics Stanford, CA
Alison C. Mawle, PhD Conference Organizing and Scientific Program Committees Centers for Disease Control and Prevention Atlanta, GA
Donna Mazyck, RN, MS NFID CME Committee National Association of School Nurses Silver Spring, MD
Renee P. McLeod, PhD, APRN, CPNP NFID CME Committee Brandman University Irvine, CA
Karen Midthun, MD Conference Organizing Committee Center for Biologics Evaluation and Research US Food and Drug Administration Bethesda, MD
on Vaccine Research Edwin O. Nuzum, DVM, PhD
Richard K. Zimmerman, MD, MPH
Conference Organizing and Scientific Program Committees National Institute of Allergy and Infectious Diseases National Institutes of Health Bethesda, MD
NFID CME Committee University of Pittsburgh School of Medicine Pittsburgh, PA
George A. Pankey, MD NFID CME Committee Ochsner Clinic Foundation New Orleans, LA
Trish M. Perl, MD, MS NFID CME Committee Johns Hopkins Hospital Baltimore, MD
Georges Peter, MD NFID CME and Conference Scientific Program Committees Warren Alpert Medical School of Brown University Providence, RI
John Petricciani, MD Conference Organizing Committee International Alliance for Biological Standardization Palm Springs, CA
NFID STAFF Ashley Cavell Education Coordinator
Joanna Colbourne Manager, Continuing Education
Sharon Cooper-Kerr Senior Director, Operations
Marla Dalton Senior Director, Education & Public Outreach
Charlotte Lazrus Executive Assistant
Len Novick Executive Director
Vincent H. Tam, PharmD, BCPS NFID CME Committee University of Houston College of Pharmacy Houston, TX
Kenneth S. Thompson, PhD NFID CME Committee Creighton University School of Medicine Omaha, NE
Patricia Whitley-Williams, MD NFID CME Committee University of Medicine & Dentristy of New Jersey Robert Wood Johnson Medical School New Brunswick, NJ
Mark Wood, DVM Conference Organizing Committee American Veterinary Medical Association Bogart, GA
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The Fifteenth Annual Conference INVITED PRESENTERS *Subject to change
Claire-Lise Chaignat, MD, MPH Chair, Global Task Force on Cholera Control World Health Organization University of Geneva Geneva, Switzerland Roy Curtiss III, PhD Professor, Life Sciences Director, Centers for Infectious Diseases and Vaccination, and Microbial Genetic Engineering Biodesign Institute Arizona State University Tempe, AZ
John J. Maurer, PhD Professor, Center for Food Safety University of Georgia College of Veterinary Medicine Athens, GA Emmanuel Mignot, MD, PhD Director, Stanford Center for Sleep Sciences Professor, Psychiatry and Behavioral Sciences Stanford University Palo Alto, CA
Suzanne L. Epstein, PhD Associate Director US Food and Drug Administration Office of Cellular, Tissue and Gene Therapies Rockville, MD
Peter L. Nara, MS, DVM, PhD (Meet the Experts Breakfast Speaker) CEO, Biological Mimetics, Inc. Director, Center for Advance Host Defense, Immunobiotics, and Translationsal Comparitive Medicine Iowa State University Ames, IA
Thomas M. File, Jr., MD, MS Chief, Infectious Disease Service Director, HIV Research Summa Health System Akron, OH
Kathleen M. Neuzil, MD, MPH Senior Clinical Advisor, Vaccines Director, Influenza Vaccine Project PATH Seattle, WA
Roger I. Glass, MD, PhD Director, Fogarty International Center Associate Director for International Research, National Institutes of Health Bethesda, MD
Christian F. Ockenhouse, MD, PhD Director, Division of Malaria Vaccine Development Walter Reed Army Institute of Research Silver Spring, MD
F. Marc LaForce, MD Director, Meningitis Vaccine Project PATH Washington, DC Philippa Marrack, PhD Investigator Howard Hughes Medical Health Denver, CO 8
Umesh Parashar, MBBS Lead, Enteric Viruses Epidemiology Team Centers for Disease Control and Prevention Atlanta, GA Daniel R. Perez, PhD Associate Director, Department of Veterinary Medicine University of Maryland, College Park College Park, MD
on Vaccine Research Stanley A. Plotkin, MD Emeritus Professor of Pediatrics University of Pennsylvania Vaxconsult LLC Doylestown, PA Gregory A. Poland, MD (Meet the Experts Breakfast Speaker) Director, Mayo Vaccine Research Group Edward Jenner Society Mayo Clinic and Foundation Rochester, MN Andrew J. Pollard, PhD Professor of Pediatric Infection and Immunity Department of Pediatrics University of Oxford Oxford, United Kingdom Andrew A. Potter, PhD CEO & Director VIDO-InterVac Saskatoon, Canada
Robert A. Seder, MD Chief, Cellular Immunology Section Vaccine Research Center, NIAID, NIH Bethesda, MD Claire-Anne Siegrist, MD, PD Director, Department of Pediatrics University of Geneva World Health Organization Geneva, Switzerland J. Erin Staples, MD, PhD Medical Epidemiologist Centers for Disease Control and Prevention Fort Collins, CO David B. Weiner, PhD Professor, Pathology and Laboratory Medicine Chair, Gene Therapy and Vaccines Graduate Program University of Pennsylvania Philadelphia, PA
Bali Pulendran, PhD Charles Howard Candler Professor of Pathology and Laboratory Medicine Director, Innate Immunity Program Director, NIH U19 Center for Systems Vaccinology Emory Vaccine Center Atlanta, GA Steven G. Reed, PhD Founder, President, and CSO Infectious Disease Research Institute Seattle, WA CAPT Stephen J. Savarino, MD, MPH Director, Enteric Disease Naval Medical Research Institute Bethesda, MD
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The Fifteenth Annual Conference Disclosures
• Ciro A. de Quadros (planner) has no relevant financial relationships.
As an organization accredited by the Accreditation Council for Continuing Medical Education (ACCME), the National Foundation for Infectious Diseases (NFID) must ensure balance, independence, objectivity, and scientific rigor in all its educational activities. NFID takes responsibility for the content, quality, and scientific integrity of this CME activity. All individuals in a position to control the content of the educational activity are required to disclose all relevant financial relationships with any commercial interest (e.g., with a pharmaceutical, medical device, biologics, or diagnostics company that manufactures products regulated by the US Food and Drug Administration). Disclosure information is reviewed in advance to manage and resolve any real or perceived conflict of interest that may affect the balance and scientific integrity of an educational presentation.
• Marla Dalton (NFID staff) has no relevant financial relationships.
Individuals in a Position to Control Content:
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• Richard J. Duma (planner) served as a speaker or member of a speaker’s bureau for Astellas, Cubist, and Pfizer Inc. • Kathryn M. Edwards (NFID CME Committee) served as an advisor or consultant for Nexbio; and received grants for clinical research from Pfizer Inc. and Novartis. • Thomas M. File, Jr. (NFID CME Committee) served as an advisor or consultant for Astellas/Theravance, Cerexa/Forest, DaiichiSankyo, GlaxoSmithKline, Merck & Co., Inc, Nabriva, Pfizer Inc., and Tetraphase; and received grants for clinical research from Cempra, Pfizer Inc., and The Medicines Company. • Cyril G. Gay (planner) owns stock, stock options, or bonds from Pfizer Inc. • Jeff Goad (planner) served as a speaker for Merck & Co., Inc.
• Lorne A. Babiuk (planner) has no relevant financial relationships.
• Debra A. Goff (NFID CME Committee) served as an advisor or consultant for Cubist, Forest, Optimer, and Cubist; and served as a speaker for Cubist and Merck & Co., Inc.
• Alan D.T. Barrett (planner) served as an advisor or consultant for GenPhar, Hawaii Biotech, and Merck & Co., Inc.
• Hana Golding (planner) has no relevant financial relationships.
• Joseph A. Bocchini, Jr. (NFID CME Committee) has no relevant financial relationships.
• George C. Hill (NFID CME Committee) has no relevant financial relationships.
• Ashley Cavell (NFID Staff) has no relevant financial relationships.
• Nancy Ivansek (NFID CME Committee) has no relevant financial relationships.
• Joanna Colbourne (NFID staff) has no relevant financial relationships.
• Abdul Jabbar (planner) has no relevant financial relationships.
• Sharon Cooper-Kerr (NFID staff) has no relevant financial relationships.
• Marguerite Jackson (NFID CME Committee and content reviewer) has no relevant financial relationships.
on Vaccine Research • Paul-Henri Lambert (planner) served as an advisor or consultant for GlaxoSmithKline, Glycovazyn, Novartis, and sanofi pasteur. • Myron M. Levine (planner) served as an advisor or consultant for American Institute of Biological Sciences (AIBS), NIAID, and WHO. • Christophe Longuet (planner) has no relevant financial relationships. • Sasha Madison (NFID CME Committee) has no relevant financial relationships. • Donna Mazyck (NFID CME Committee) has no relevant financial relationships. • Renee P. McLeod (NFID CME Committee) served as a speaker of member of a speaker’s bureau for GlaxoSmithKline. • Karen Midthun (planner) has no relevant financial relationships. • Len Novick (NFID staff) owns stock, stock options, or bonds from Cubist, Pfizer Inc., and Viropharma. • Edwin O. Nuzum (planner) has no relevant financial relationships. • George A. Pankey (NFID CME Committee) has no relevant financial relationships.
• John Petricciani (planner) served as an advisor or consultant for iBiopharma and Vazin; and owns stock, stock options, or bonds from Ampliphi, Arbor Vita, Micromet, Pfizer Inc., and Vaxin. • Gregory A. Poland (planner) served as an advisor or consultant for Avianax, Dynavax, Liquidia Technologies, Inc., Merck & Co., Inc., Novartis, Ofstead and Associates, PaxVax Inc., and Theraclone Sciences. • Susan J. Rehm (NFID Medical Director) served as an advisor or consultant for Merck & Co., Inc. and Pfizer Inc.; and served as a speaker for Genentech. • Vincent Tam (NFID CME Committee) served as an advisor or consultant for Merck & Co., Inc.; received grants for clinical research from Ortho-McNeil and Merck & Co., Inc.; and served as a speaker or member of a speaker’s bureau for AstraZeneca and Merck & Co., Inc. • Kenneth S. Thomson (NFID CME Committee) served as an advisor or consultant for Novartis; holds a patent from Becton Dickenson; received grants for clinical research from bioMérieux, Cubist, Merck & Co., Inc, Pfizer Inc., Rib-X, Truis; and served as a speaker for Becton Dickinson and Merck & Co., Inc.
• Trish M. Perl (NFID CME Committee) served as an advisor or consultant for bioMérieux, Hospira (Theradoc), and Pfizer Inc.; received grants for clinical research from Merck & Co., Inc. and Sage; and owns stock, stock options, or bonds from Theradoc.
• Bruce G. Weniger (planner) owns stock, stock options, or bonds from Pfizer Inc. and Roche.
• Georges Peter (Chair, NFID CME Committee) served as an advisor, consultant, or speaker for Pfizer Inc.; and owns stock, stock options, or bonds from Bristol Myers Squibb and Pfizer Inc.
• Richard K. Zimmerman (NFID CME Committee) served as an advisor or consultant for MedImmune, Inc.; and received grants for clinical research from MedImmune, Inc. and Merck & Co., Inc.
• Patricia Whitley-Williams (NFID CME Committee) received grants for clinical research from J & J Foundation.
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The Fifteenth Annual Conference ACCREDITATION
GENERAL INFORMATION
CONTINUING MEDICAL EDUCATION (CME) CREDITS The National Foundation for Infectious Diseases is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
AMERICANS WITH DISABILITIES ACT The Hyatt Regency Inner Harbor is fully accessible to the public in accordance with the Americans with Disabilities Act guidelines. If you have any special meeting needs or requirements, please contact either Sharon Cooper-Kerr at
[email protected] or a member of the Hyatt hotel staff.
The National Foundation for Infectious Diseases designates this educational activity for a maximum of 19.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CONFERENCE INFORMATION DESK The Conference Information Desk is located in the foyer area outside the Constellation Ballroom in the Hyatt Regency Inner Harbor. NFID staff will be available at the desk throughout the conference.
CONTINUING NURSING EDUCATION (CNE) CREDITS NFID is an approved provider of continuing nursing education by the Maryland Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. This educational activity has been approved for a maximum of 19.25 contact hours. To receive credit, each participant must attend the entire program and complete a daily sign-in sheet. After the course, participants must complete the conference evaluation (see below).
CONFERENCE LANGUAGE The official language for the conference is English.
CONFERENCE EVALUATION For CME and CNE credit, visit www.meetingproceedings.com/NFID/ACVR12.htm to complete the conference evaluation and earn continuing education credits. You will need your registration confirmation number to access the online conference evaluation. The confirmation number can be found on your registration confirmation email, or following the conference, attendees will receive a reminder email that includes the confirmation number. Emails will be sent to the email address used at the time of registration. For additional assistance, please contact Ashley Cavell, NFID Education Coordinator, at
[email protected].
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CONFERENCE LOCATION All sessions of the conference will be held at: Hyatt Regency Inner Harbor 300 Light Street Baltimore, MD 21202 (410) 528-1234 EXHIBIT HALL Visit the Exhibit Hall in the Maryland Suites to meet with representatives from companies displaying the latest technologies in vaccine-related products and services. The exhibit hall hours are: Monday, May 7 Tuesday, May 8
5:00–7:00 pm 7:30 am–1:00 pm
A prize drawing will be held on Tuesday, May 8, at 1:15 pm. Be sure to get your exhibitor passport stamped by each of the exhibitors and return to the conference registration desk by 1:00 pm, Tuesday, May 8, to qualify for the drawing. Attendees must be present to win.
on Vaccine Research GREEN INITIATIVES NFID is committed to implementing sustainability practices that will lessen the impact of its events on the planet. This includes working with the conference hotel, suppliers, and attendees to find ways to reduce our environmental impact. NFID actions include: Printing meeting materials on recycled paper, using environmentally friendly ink. To reduce the amount of paper used, presentations will be made available online after the conference. Encouraging attendees to reduce, reuse, and recycle paper, metal, plastic, and glass. Recycle your badge before you leave -- look for the boxes as you exit the session. In addition to paper, cans, or bottles, remember you can recycle your poster as well. All posters are recyclable, as long as they are not laminated. Using reusable servicewear such as cups, mugs, plates, and cutlery when possible. Attendees are encouraged to bring a reusable water bottle to the meeting—water stations are available throughout the conference hotel. Attendees are asked to turn off lights and other electronics when not in use; to participate in the Hyatt linen reuse program for towels and bed linens; and to take advantage of the many public transportation options throughout the city. We encourage you to walk around town or explore the area using the city’s buses or light rail to discover Baltimore. MEET THE EXPERTS The Meet the Experts sessions are conducted in a small group format focusing on interaction between invited experts and attendees. The format is conducive to informal discussion led by introductory remarks from the expert and followed by questions and answers from the participants. The sessions are open to all attendees; however, seating capacity is limited and is available on a first-come, first-served basis. Please be sure to take advantage of this networking opportunity for a thoughtful exchange of ideas among peers, mentors, and colleagues. The breakfast sessions are scheduled for Tuesday, May
8 and Wednesday, May 9 from at 7:00–7:45 am, in Constellation Ballroom, Salon C. Discussion leaders and topics are as follows: (please refer to pages 38-51 for leader biographical information)
Tuesday, May 8 Correlates of Protection by Vaccines Stanley A. Plotkin, MD
Preparing & Publishing an Academic Paper: Discussion with a Journal Editor Gregory A. Poland, MD
New Developments in Vaccines Against Bacterial Enteric Pathogens CAPT Stephen J. Savarino, MD, MPH
Meningitis Vaccines for Sub–Saharan Africa: The Reality of a Paucity of Resources F. Marc LaForce, MD
Wednesday, May 9 Public Perception on the Use of Live Influenza Vaccines in the Veterinary Field Daniel R. Perez, PhD
New Technologies in Vaccine Design Roy Curtiss III, PhD
Immunological Hierarchy and its Role in the Future Rational Design of Vaccines Peter L. Nara, MS, DVM, PhD
How Vaccines Work Philippa Marrack, PhD
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The Fifteenth Annual Conference MESSAGES All sleeping rooms in the hotel are equipped with a voice mail system. This system is accessible via the hotel operator using a house phone. In case of emergencies requiring immediate attention, your party should call the general hotel number and instruct the switchboard to deliver a message to Sharon Cooper-Kerr at the NFID Conference Information Desk in the foyer area outside of the Constellation Ballroom. NO SMOKING POLICY The Hyatt Regency Inner Harbor is a non-smoking facility. No smoking is allowed in any of the session rooms, break areas, or sleeping rooms. POSTER SESSIONS Posters will be on display from 5:00 pm on Monday, May 7 until 12:00 pm on Wednesday, May 9 in the atrium of the hotel. Presenters will be at their boards to answer questions and discuss their research during the poster reception scheduled for Monday, May 7, at 5:00 pm and during the official poster session on Tuesday, May 8, from 7:30–8:30 am. PROGRAM AND ABSTRACTS The registration fee includes one copy of the Program Agenda and Abstract Book for each registered participant. Additional copies, if available, may be purchased for $25 US each. Orders for additional copies will be taken at the Conference Information Desk beginning on Tuesday, May 8, 2012 and after the conference by e-mail to
[email protected] or fax to (301) 907-0878. Please note that NFID is unable to replace lost or stolen ABSTRACT Books. PRESENTATIONS With the permission of each presenter, presentation slides will be posted online following the conference for one month. Registered attendees will be notified by email when the slides are available.
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REGISTRATION FEES AND HOURS The onsite registration fees are $620 US (Full Registration) and $525 US (NFID Supporting Member). Space is limited and onsite registrations will be accepted on a first come, first served basis. The registration fee includes a program/abstract book, continental breakfast on each day of the conference, all scheduled coffee breaks, reception on Monday evening, and luncheon on Tuesday. Accommodations and additional meals are not included. VERIFICATION OF ATTENDANCE International attendees may obtain a letter of attendance verification from the NFID staff at the Conference Information Desk during registration hours. AFFILIATED EVENTS AND OTHER MEETINGS Monday, May 7, 2012 Infectious Diseases In Clinical Practice Lunch 12:00 pm, Pratt/Calvert Room (Closed meeting, by invitation only) Tuesday, May 8, 2012 ACVR Organizing and Scientific Program Committees Meeting 6:00-9:00 pm, Constellation C (Closed meeting, by invitation only) Thursday, May 10–Friday, May 11, 2012 IABS International Scientific Workshop Adventitious Agents, New Technology, and Risk Assessment Hyatt Regency Inner Harbor Baltimore, MD
on Vaccine Research NFID Luncheon May 8, 2012 12:00–1:15 pm Opening Remarks and Introductions Bruce G. Weniger, MD, MPH Robert Austrian Memorial Lecture Thomas M. File, Jr., MD, MS Presentation of Dr. Charles Mérieux Award Susan J. Rehm, MD Dr. Charles Mérieux Award Acceptance Arnold S. Monto, MD Presentation of Maurice R. Hilleman Early-Stage Career Investigator Award (Recipient To Be Announced) Bruce G. Weniger, MD, MPH
Thomas M. File, Jr., MD, MS 2012 Robert Austrian Memorial Lecturer President-elect, National Foundation for Infectious Diseases Chair, Division of Infectious Disease, Summa Health System, Akron, OH Professor, Internal Medicine; Master Teacher; Chair, Infectious Disease Section, Northeast Ohio Medical University, Rootstown, OH
Arnold S. Monto, MD 2012 Dr. Charles Mérieux Award Recipient Thomas Francis Jr. Collegiate Professor of Epidemiology University of Michigan School of Public Health, Ann Arbor, MI
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The Fifteenth Annual Conference Robert Austrian Memorial Lecture The Robert Austrian Memorial Lecture honors the late Robert Austrian, MD, a University of Pennsylvania researcher who developed the first multivalent vaccine against pneumococcal bacteria. Dr. Austrian received his Doctor of Medicine degree from Johns Hopkins University and completed fellowships in infectious diseases at Johns Hopkins and New York University. He went on to found the infectious diseases division and fellowship program at the University of Pennsylvania and was chairman of the department of research medicine there from 1962 to 1986. Among his many honors, Dr. Austrian received the NFID’s Maxwell Finland Award for Scientific Achievement in 2001.
Dr. Charles Mérieux Award Dr. Charles Mérieux was a French scientist, humanist, and entrepreneur, who devoted his life to the prevention of infectious diseases. At the age of 30, he took over the family laboratory founded by his father in 1897, and turned it into one of the leading vaccine manufacturing companies in the world, known today as sanofi pasteur. His work and vision laid important foundations for the vaccine industry and the worldwide fight to control and eliminate infectious diseases through immunization. This Award is presented to an individual who demonstrates a commitment to science-based medicine and research in infectious diseases, shows excellence in clinical and research activities, and has an unsurpassed dedication to improving public health.
Maurice R. Hilleman Early-Stage Career Investigator Award The Maurice R. Hilleman Early Stage Career Investigator Award memorializes the lifetime achievements of Dr. Maurice R. Hilleman in the field of vaccinology. Dr. Hilleman was a long-serving member of the National Foundation for Infectious Diseases’ Board of Directors and Board of Trustees and was the 1998 recipient of NFID’s Maxwell Finland Award for Scientific Achievement. This award recognizes promising scientists in the early stages of their careers in any field of vaccinology, from basic research, through pre-clinical and clinical studies, manufacturing, and production, to related research in public health, agriculture, health delivery, policy, and regulatory matters.
This session is supported by grants from Merck & Co., Inc. and sanofi pasteur.
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on Vaccine Research MARY LOU CLEMENTS-MANN MEMORIAL LECTURE IN VACCINE SCIENCES Marc La Force, MD, Director of PATH in Washington DC, will present the 2012 Mary Lou ClementsMann Memorial Lecture, “Introduction of an Affordable Group A Meningococcal Conjugate Vaccine in the African Meningitis Belt” on Tuesday, May 8, 2012 at 8:30 am. Abstract on page 59. The Mary Lou Clements-Mann Memorial Lecture in Vaccine Sciences was initiated at the Second Annual Conference on Vaccine Research in 1999 to honor and remember a prolific, compassionate, and courageous vaccinologist. Dr. Clements-Mann was a professor in the John Hopkins University School of Hygiene and Public Health, where she worked starting in 1985, founding and directing its Center for Immunization Research. Her career in vaccine science began in 1979, when she joined the Center for Vaccine Development at the University of Maryland School of Medicine as assistant professor of medicine. Dr. Clements-Mann was internationally recognized for her clinical research and leadership on viral vaccines of public health importance. Her bibliography includes more than 100 papers indexed to vaccination for influenza (37), HIV (31), cholera (6), hepatitis B (5), respiratory syncytial virus (4), parainfluenza (4), Rocky Mountain spotted fever (4), rotavirus (3), E. coli (3), and typhoid (1). Raised on a Texas ranch, Mary Lou Clements entered Texas Tech University intending to become a veterinarian, but her interests soon changed to human disease, and upon graduation she attended the University of Texas Southwestern Medical School. After completing an internship and residency at Temple University in Philadelphia, she obtained a diploma at the London School of Tropical Medicine and Hygiene in 1975. At that time, the frontlines of public health were in the global program to eradicate smallpox, and she went to India to work for the World Health Organization (WHO) for the final years of vaccination and surveillance. After returning in 1977, she moved to Baltimore to earn her MPH degree at Hopkins. It was quite early in the AIDS pandemic when Dr. Clements-Mann founded the Center for Immunization Research, but she recognized the threat of this new disease and made it a major focus of her research. She became a dominant figure in the multi-center networks established by the National Institutes of Health to conduct phase I and II clinical trials of AIDS vaccines. She also consulted for WHO and the joint United Nations Programme on AIDS to help prepare for essential AIDS vaccine trials in developing countries. Her great contributions to these efforts arose from her broad experience testing vaccines for other diseases, and her vision for how to move forward the development process. In 1996, she married Dr. Jonathan Mann, founder of the Global Programme on AIDS at WHO, an international authority on the pandemic, and an eloquent advocate for human rights and compassion in controlling it. In the final years of their lives, they became increasingly frustrated with impediments to AIDS vaccine development not faced by other vaccines, and began crusading -- despite the risk to her peer-reviewed research grants -- for a reinvented Federal AIDS vaccine effort. This was the theme of Dr. Clements-Mann’s invited lecture before the First Annual Conference on Vaccine Research on May 30, 1998. On September 2 of that year the couple perished in the crash of Swissair flight 111 off the coast of Nova Scotia, Canada.
17
The Fifteenth Annual Conference PROGRAM AGENDA
SUNDAY, MAY 6, 2012 4:00–6:30 pm
Registration
Constellation Ballroom Foyer/Atrium
MONDAY, MAY 7, 2012 7:15 am–5:00 pm
Registration
Constellation Ballroom Foyer/Atrium
7:30 am
Poster Set–Up
Atrium
7:45 am
Continental Breakfast
Constellation Ballroom Foyer/Atrium
8:15 am
Welcome and Introductions Susan J. Rehm, MD National Foundation for Infectious Diseases Bethesda, MD
8:30 am
Keynote Address Constellation Ballroom, Salon A & B CE Moderator: John Petricciani, MD International Alliance for Biological Standardization Palm Springs, CA
1
Vaccine Discovery – A Varied Process Stanley A. Plotkin, MD University of Pennsylvania Vaxconsult LLC Doylestown, PA
9:15 am
Questions and Answers
9:30 am Coffee Break
Symposium 1:
Advances in Vaccine Discovery CE
Moderator: Cyril G. Gay, DVM, PhD US Department of Agriculture Beltsville, MD
9:45 am
2
18
Constellation Ballroom, Salon A & B
Advances in Influenza Virus Vaccine Discovery and Immunology Daniel R. Perez, PhD Department of Veterinary Medicine University of Maryland, College Park College Park, MD
on Vaccine Research PROGRAM AGENDA 10:15 am
3
Vaccines for Malaria Elimination: Progress and Challenges Ahead Christian F. Ockenhouse, MD, PhD Division of Malaria Vaccine Development Walter Reed Army Institute of Research Silver Spring, MD
10:45 am 4
Novel Engineering of Synthetic HIV–1 Consensus Envelop Second Generation DNA Vaccines David B. Weiner, PhD University of Pennsylvania Philadelphia, PA
11:15 am 5
Progress on Universal Influenza Vaccines: Protecting against Unexpected Outbreaks and Pandemics Suzanne L. Epstein, PhD US Food and Drug Administration Office of Cellular, Tissue and Gene Therapies Rockville, MD
11:45 am
Questions and Answers
12:00 pm
Lunch (on your own)
Symposium 2:
Rotavirus Vaccines CE
Constellation Ballroom, Salon A & B
Moderator: Myron M. Levine, MD, DTPH Center for Vaccine Development University of Maryland School of Medicine Baltimore, MD
1:00 pm 6
An Introduction to Rotavirus Vaccines and Remaining Challenges Ahead Roger I. Glass, MD, PhD Fogarty International Center National Institutes of Health Bethesda, MD
1:30 pm 7
Rotavirus Vaccines: A Review of Vaccine Trial Results Kathleen M. Neuzil, MD, MPH PATH Seattle, WA
19
The Fifteenth Annual Conference PROGRAM AGENDA 2:00 pm 8
Post–Licensure Surveillance: The Impact of Vaccines and Concerns About Intussusception Umesh Parashar, MBBS Centers for Disease Control and Prevention Atlanta, GA
2:30 pm
Questions and Answers
3:00 pm
Coffee Break
Submitted Presentations 1A Vaccine Candidates: Preclinical and Clinical Studies CE (Concurrent Sessions) Moderator: Bruce G. Weniger, MD
Constellation Ballroom, Salon A
Vaccine Chiang Mai University Atlanta, GA
3:30 pm
S1 Recombinant Oligomeric HA1 Vaccine Generates Higher Affinity Antibodies than Subunit H5N1 Vaccine Resulting in Reduced Viral Loads Following Heterologous H5N1 challenge in Ferrets S. Verma1, M. Dimitrova1, T. M. Ross2, S. Khurana1, H. Golding1 1 Division of Viral Products, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), Bethesda, MD, 2Center for Vaccine Research, University of Pittsburgh, Pittsburgh, PA 3:45 pm
S2 Preclinical Studies of Live Attenuated Non-Typhoidal Salmonella Vaccines Including Safety in SIV-Infected Rhesus Macaques S. M. Tennant1, A. Ault2, J. Wang1, J. E. Galen1, S. Livio1, R. Simon1, M. Pasetti1, O. Gat1, J. P. Gorres2, J. Estes3, M. Eckhaus4, N. Sandler5, D. Douek5, S. Bao2, K. Foulds4, M. Roederer4, S. Kao4, G. Nabel2, S. S. Rao2, M. M. Levine1 1 Center for Vaccine Development, University of Maryland Baltimore, Baltimore, MD, 2Vaccine Research Center, NIAID, NIH, Bethesda, MD, 3AIDS and Cancer Virus program, Science Applications International Corporation-Frederick, Inc, National Cancer Institute, Frederick, MD, 4Veterinary Resources Program, Office of Research Services, NIH, Bethesda, MD, 5Human Immunology Section, Vaccine Research Center, NIAID, NIH, Bethesda, MD 4:00 pm
S3 Novel Structurally Designed Vaccine for S. aureus a-Hemolysin: Protection against Bacteremia/Sepsis and Pneumonia M. Aman, H. Karauzum, R. P. Adhikari, J. Sarwar, L. Abaandou, M. Mahmoudieh, H. Vu, A. Rezaei-Boroun, S. Shulenin, T. Nguyen, S. Venkataramani, K. L. Warfield Integrated BioTherapeutics, Gaithersburg, MD 20
on Vaccine Research PROGRAM AGENDA 4:15 pm
S4 NDV-3, a Recombinant Alum-Adjuvanted Vaccine for Candida and Staphylococcus aureus is Safe and Immunogenic in Healthy Adults J. P. Hennessey, Jr.1, C. S. Schmidt1, C. J. White2, A. S. Ibrahim3, S. G. Filler3, M. R. Yeaman4, Y. Fu3, J. E. Edwards, Jr.3 1 NovaDigm Therapeutics, Grand Forks, ND, 2CJW Consulting, Ambler, PA, 3Infectious Disease, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA, 4Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA
4:30 pm
S5 Pfs25-EPA/Alhydrogel, a Transmission Blocking Vaccine Against Falciparum Malaria R. D. Ellis LMIV/NIAID/NIH, Rockville, MD
4:45 pm
S6 Safety Signal Associated with Recombinant BCG Vaccination: Immunologic Clue or Chance Occurrence? D. F. Hoft1, A. Blazevic1, A. Selimovic1, A. Turan1, J. Tennant1, G. Abate1, J. Fulkerson2, R. Walker2, J. Scott2, J. Ishmukhamedov2, D. Hokey2, V. Dheenadhayalan2, L. Barker2, R. Wallis3, A. A. Gershon4, M. D. Gershon4, S. Steinberg1 1 Departments of Internal Medicine & Molecular Microbiology, Saint Louis University, St. Louis, MO, 2Aeras Global TB Vaccine Foundation, Rockville, MD, 3Pfizer Global Research & Development, New London, CT, 4Columbia University, New York, NY
Submitted Presentations 1B Immunization Policies and Programs CE
Constellation Ballroom, Salon B
(Concurrent Sessions) Moderator: Susan J. Rehm, MD
National Foundation for Infectious Diseases Bethesda, MD
3:30 pm
S7 Universal Tdap Vaccination: What Adults Need and Want to Know B. A. Halperin1, D. M. MacDougall2, D. Janowitz1, D. MacKinnon-Cameron1, J. Langley1, S. A. McNeil1, S. Halperin1 1 Canadian Center for Vaccinology, Dalhousie University, Halifax, Nova Scotia, Canada, 2Canadian Center for Vaccinology, St. Francis Xavier University, Antigonish, Nova Scotia, Canada
3:45 pm
S8 Cost Effectiveness of Outpatient Standing Order Programs for Both Influenza and Pneumococcal Polysaccharide Vaccination C. Lin1, R. Zimmerman2, M. P. Nowalk1, K. J. Smith3 1 Family Medicine, University of Pittsburgh, Pittsburgh, PA, 2Family Medicine & Clinical Epidemiology, University of Pittsburgh, Pittsburgh, PA, 3Internal Medicine, University of Pittsburgh, Pittsburgh, PA
21
The Fifteenth Annual Conference PROGRAM AGENDA 4:00 pm
S9 Coverage from Ontario’s School-Based HPV Vaccination Program: The First Three Years S. Wilson1, T. Harris1, P. Sethi2, J. Fediurek1, S. L. Deeks1 1 Surveillance and Epidemiology, Public Health Ontario, Toronto, Ontario, Canada, 2 Ministry of Health and Long Term Care, Toronto, Ontario, Canada
4:15 pm
S10 Smaller Pediatric Offices Have Higher In-Office Influenza Vaccination Rates S. L. Toback1, E. Rothstein2, P. Bhatt3, W. Carr4, X. Wu1, C. S. Ambrose1 1 MedImmune, LLC, Gaithersburg, MD, 2Pennridge Pediatric Associates, Sellersville, PA, 3Pediatric & Adolescent Medicine, Lock Haven, PA, 4Stafford Pediatrics, Stafford, VA
4:30 pm
S11 Increasing Childhood Influenza Vaccination Rates: Interim Results on the Impact of the Childhood Influenza Vaccination Toolkit R. Zimmerman1, K. Hannibal2, E. Reis2, C. Lin3, G. Gallik4, K. Moehling3, A. Matambanadzo3, A. O’Donnell4, J. Troy1, K. Bhat-Schelbert3, M. Diamond5, T. G. Lynch5, D. H. Wolfson5, M. P. Nowalk3 1 Family Medicine & Clinical Epidemiology, University of Pittsburgh, Pittsburgh, PA, 2 Pediatrics, University of Pittsburgh, Pittsburgh, PA, 3Family Medicine, University of Pittsburgh, Pittsburgh, PA, 4Family Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA, 5Childrens Community Pediatrics, Pittsburgh, PA
4:45 pm
S12 Implementation of a Universal Rotavirus Vaccination Program: Comparison of Public Health Nurse and Physician-based Programs D. MacDougall1, B. A. Halperin2, C. Sanford3, M. Zelman3, G. Watson-Creed4, P. Publicover-Brouwer5, D. MacKinnon-Cameron5, P. Rykers5, J. Langley6, A. Neatby3, C. Rowswell3, S. A. Halperin6 1 School of Nursing, St. Francis Xavier University, Antigonish, NS, Canada, 2School of Nursing, Dalhousie University, Halifax, NS, Canada, 3Health and Wellness, Province of Prince Edward Island, Charlottetown, PE, Canada, 4Health and Wellness, Province of Nova Scotia, Halifax, NS, Canada, 5Canadian Center for Vaccinology, Dalhousie University, Halifax, NS, Canada, 6Pediatrics, Dalhousie University, Halifax, NS, Canada
5:00–7:00 pm
22
Exhibits and Poster Reception
Atrium and Maryland Suites
on Vaccine Research PROGRAM AGENDA
TUESDAY, MAY 8, 2012 7:00 am–5:00 pm
Registration
Constellation Ballroom Foyer/Atrium
7:00 –7:45 am
Meet the Experts Breakfast Session
Constellation Ballroom, Salon C
Correlates of Protection by Vaccines Stanley A. Plotkin, MD University of Pennsylvania Vaxconsult LLC Doylestown, PA
Preparing & Publishing an Academic Paper: Discussion with a Journal Editor Gregory A. Poland, MD The Jenner Society Mayo Clinic and Foundation Rochester, MN
New Developments in Vaccines Against Bacterial Enteric Pathogens CAPT Stephen J. Savarino, MD, MPH Department of Enteric Diseases Naval Medical Research Institute Bethesda, MD
Meningitis Vaccines for Sub–Saharan Africa: The Reality of a Paucity of Resources F. Marc LaForce, MD PATH Washington, DC
7:30 –8:30 am
Continental Breakfast/Poster Session with the Presenters
Atrium and Maryland Suites
7:30 am–1:00 pm
Exhibit Hall Hours
Maryland Suites
8:30 am
Mary Lou Clements–Mann Constellation Ballroom, Salon A & B Memorial Lecture in Vaccine Sciences CE
(See page 15)
Moderator: Myron M. Levine, MD, DTPH Center for Vaccine Development University of Maryland School of Medicine Baltimore, MD
9
Introduction of an Affordable Group A Meningococcal Conjugate Vaccine in the African Meningitis Belt F. Marc LaForce, MD PATH Washington, DC
23
The Fifteenth Annual Conference PROGRAM AGENDA 9:15 am 9:30 am
Questions and Answers Coffee Break
Symposium 3:
CE Vaccines for Enteric Diseases
Moderator: Myron M. Levine, MD, DTPH Center for Vaccine Development University of Maryland School of Medicine Baltimore, MD
Constellation Ballroom, Salon A & B
9:45 am 10
The Challenge of Typhoid Andrew J. Pollard, PhD Department of Paediatrics University of Oxford Oxford, UK
10:20 am
Human Vaccines Against Enterotoxigenic Escherichia coli Diarrhea: Old Themes and New Developments CAPT Stephen J. Savarino, MD, MPH Department of Enteric Diseases Naval Medical Research Institute Bethesda, MD
10:55 am 12
Role for Cholera Vaccines as an Adjunct Control Measure During Cholera Outbreaks in Complex Emergencies Claire–Lise Chaignat, MD, MPH World Health Organization University of Geneva Geneva, Switzerland
11
11:30 am
Questions and Answers
12:00 pm
NFID Luncheon (See page 15)
Constellation Ballroom, Salon C-F
Robert Austrian Memorial Lecture by Thomas M. File, Jr., MD, MS Chief, Infectious Disease Service, Director, HIV Research, Summa Health System, Akron, OH Charles Mérieux Award Presentation to Arnold S. Monto, MD Thomas Francis Jr. Collegiate Professor of Epidemiology, University of Michigan School of Public Health, Ann Arbor, MI Maurice R. Hilleman Early–Stage Career Investigator Award Presentation
24
on Vaccine Research PROGRAM AGENDA
Symposium 4:
CE Food Safety Vaccines
1:30 pm
13
Constellation Ballroom, Salon A & B
Moderator: Edwin O. Nuzum, DVM, PHD National Institute of Allergy and Infectious Diseases National Institutes of Health Bethesda, MD
The Effectiveness of Vaccines at Reducing Salmonella Contamination of Poultry John J. Maurer, PhD Center for Food Safety University of Georgia College of Veterinary Medicine Athens, GA
14 2:00 pm
New Technologies in Vaccine Design Roy Curtiss III, PhD Biodesign Institute Arizona State University Tempe, AZ
15 2:30 pm
Control of Verotoxigenic Escherichia coli Colonization of Cattle by Vaccination: Threats and Opportunities Andrew A. Potter, PhD VIDO–InterVac Saskatoon, Canada
3:00 pm
Questions and Answers
3:30 pm
Coffee Break
Submitted CE Presentations 2A Immunologic Science
Constellation Ballroom, Salon A
(Concurrent Sessions) Moderator: Hana Golding, PhD
4:00 pm
Center for Biologics Evaluation and Research US Food and Drug Administration Bethesda, MD
S13 Antibody to the Neuraminidase (NA) Independently Protects against Infection and Illness from Naturally-Occurring Influenza in the Presence of Antibody to the Hemagglutinin (HA) R. B. Couch1, R. L. Atmar2, L. M. Franco3, J. M. Quarles4, D. Nino5, J. Wells, P.A.5, N. Arden4, S. Cheung5, B. A. Ellis1, J. W. Belmont6 1 Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, TX, 2Medicine and Molecular Virology & Microbiology, Baylor College of Medicine, Houston, TX, 3Medicine and Molecular & Human Genetics, Baylor College of Medicine, Houston, TX, 4College of Medicine, Texas A&M Health Science
25
The Fifteenth Annual Conference PROGRAM AGENDA Center, College Station, TX, 5Molecular Virology & Microbiology, Baylor College of Medicine, Houston, TX, 6Departments of Molecular & Human Genetics, Pediatrics and Pathology & Immunology, Baylor College of Medicine, Houston, TX 4:15 pm
S14 Immune Response Following H1N1pdm09 Infection and Vaccination: Differences in Antibody Repertoire and Avidity in Young and Elderly Populations N. K. Verma1, M. Dimitrova1, T. M. Ross2, K. R. Talaat3, R. A. Karron3, H. Golding1, S. Khurana1 1 Division of Viral Products, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), Bethesda, MD, 2Center for Vaccine Research, University of Pittsburgh, Pittsburgh, PA, 3Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
4:30 pm
S15 Follicular T Helper Cell Expansion as a Potential Target for Novel Early Life Immunization Strategies B. Mastelic1, A. T. Kamath1, P. Fontannaz1, C. Tougne1, A. Rochat1, E. Belnoue1, C. Combescure2, F. Auderset3, P. Lambert1, F. Tacchini-Cottier3, C. Siegrist1 1 Departments of Pathology-Immunology and Pediatrics, University of Geneva, World Health Organization Collaborating Center for Vaccine Immunology, Geneva, Switzerland, 2University Hospitals of Geneva, Clinical Research Center, Geneva, Switzerland, 3Department of Biochemistry, World Health Organization Immunology Research and Training Center, University of Lausanne, Epalinges, Switzerland
4:45 pm
S16 Respiratory Syncytial Virus Surface Glycoproteins F and G Play a Critical Role in Modulating Antibody Production through Interactions with Toll-Like Receptor 4 V. M. Wurster1, V. Wimmenauer2, D. Hijano1, P. Acosta2, S. Coviello2, F. P. Polack2 1 Vanderbilt University School of Medicine, Nashville, TN, 2Fundacion Infant, Buenos Aires, Argentina
5:00 pm
S17 Granzyme A Produced by gamma9delta2 T cells Induces Human Macrophages to Inhibit Growth of an Intracellular Pathogen I. G. Sakala1, C. T. Spencer2, G. Abate1, S. M. Truscott1, R. Lin1, A. Blazevic1, S. S. Metkar3, C. J. Froelich3, D. F. Hoft4 1 Department of Internal Medicine, Saint Louis University, Saint Louis, MO, 2 Department of Molecular Microbiology and Immunology, Saint Louis University, Saint Louis, MO, 3Department of Medicine, NorthShore University HealthSystems Research Institute, Chicago, IL, 4Department of Internal Medicine and Molecular Microbiology and Immunology, Saint Louis University, Saint Louis, MO
26
on Vaccine Research PROGRAM AGENDA
Submitted Presentations 2B Impact of Vaccines on Disease Burden CE
Constellation Ballroom, Salon B
(Concurrent Sessions) Moderator: Georges Peter, MD
Warren Alpert Medical School of Brown University Brookline, MA
4:00 pm
S18 Immunological-Stimulating Content of Vaccines and Neuropsychological Outcomes in Children S. Iqbal1, J. Barile2, B. Stewart1, E. Weintraub1, W. W. Thompson2, F. DeStefano1 1 Immunization Safety Office, National Center for Emerging and Zoonotic Infectious Disease, Centers for Disease Control and Prevention, Atlanta, GA, 2Div. of Adult and Community Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, GA
4:15 pm
S19 Does Live Attenuated Influenza Vaccine Reduce All-Cause Acute Otitis Media in Children? T. Heikkinen1, S. L. Block2, S. L. Toback3, C. S. Ambrose3; 1 Turku University Hospital, Turku, FINLAND, 2Kentucky Pediatric and Adult Research, Bardstown, KY, 3MedImmune, LLC, Gaithersburg, MD
4:30 pm
S20 Indirect Effectiveness of Vaccinating Schoolchildren Against Influenza, São Paulo, Brazil, 2009 V. L. Gattás1, C. M. Machado2, E. J. Luna3 1 Health Secretariat, Butantan Institute, São Paulo, Brazil, 2University of Sao Paulo, Institute of Tropical Medicine, São Paulo, Brazil, 3University of Sao Paulo, Inst, São Paulo, Brazil
4:45 pm
S21 Modeling the Impact of Vaccination on the Epidemiology of Cytomegalovirus (CMV) and Congenital CMV Infection in the United States - Preliminary Findings T. M. Lanzieri1, M. Gambhir2, I. Ortega-Sanchez1, S. R. Bialek1 1 Division of Viral Diseases/National Center for Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, 2MRC Centre for Outbreak Analysis and Modelling, Imperial College London, UK, Office of the Director/National Center for Immunizations and Respiratory Diseases/Centers for Disease Control and Prevention, Atlanta, GA
5:00 pm
S22 Estimation of Typhoid Cost of Illness in Developing Countries V. Mogasale1, B. Maskery, Y. Kim, R. Ochiai, T. F. Wierzba 1 Translational Research Division, International Vaccine Institute (IVI), Seoul, Republic of Korea
27
The Fifteenth Annual Conference PROGRAM AGENDA
WEDNESDAY, MAY 9, 2012 7:00 am–12:00 pm Registration
Constellation Ballroom Foyer/Atrium
7:00 –7:45 am
Meet the Experts Breakfast Session
Public Perception on the Use of Live Influenza Vaccines in the Veterinary Field Daniel R. Perez, PhD University of Maryland, College Park College Park, MD
New Technologies in Vaccine Design Roy Curtiss, III, PhD Arizona State University Tempe, AZ
Immunological Hierarchy and its Role in the Future Rational Design of Vaccines Peter L. Nara, MS, DVM, PhD Iowa State University Biological Mimetics, Inc. Ames, IA
7:30 am
Continental Breakfast
7:30 am–12:00 pm
Posters on Display
Constellation Ballroom, Salon C
How Vaccines Work Philippa Marrack, PhD Howard Hughes Medical Health Denver, CO
Submitted Presentations 3A Adjuvants and Antigen Development CE (Concurrent Sessions) Moderator: Cyril G. Gay, DVM, PhD
Atrium
Constellation Ballroom, Salon A
US Department of Agriculture Beltsville, MD 8:00 am
28
S23 The Combination of Cationic Peptide and CpG Provides Superior Adjuvant Activity for the Induction of Protection Against WNV NY99 Infection M. S. Wanyonyi Pathology, Duke University, Durham, NC
on Vaccine Research PROGRAM AGENDA 8:15 am
S24 Despite Pre-Existing Ad5 Immunity, Recombinant Adenovirus Vectors Expressing the Innate Immune Modulator EAT-2 Elicits Potent Effector Memory T Lymphocyte Responses Y. A. Aldhamen, S. S. Seregin, N. J. Schuldt, D. P. Rastall, S. Godbehere, A. Amalfitano Microbiology and Molecular Genetics, Michigan State University, East Lansing, MI
8:30 am
S25 Immune Response and Protective Efficacy of Live Attenuated Salmonella Vaccine Expressing Antigens of Mycobacterium avium subspecies paratuberculosis against Challenge in Mice Model S. M. Faisal, S. Chandra, J. Chen, Y. Chang College of Veterinary Medicine, Cornell University, Ithaca, NY
8:45 am
S26 Recombinant Attenuated Vaccine Candidates for S. aureus Panton Valentine Leukocidin M. Aman, H. Karauzum, R. Adhikari, J. Sarwar, L. Abaandou, M. Mahmoudieh, H. Vu, A. Rezaei-Boroun, S. Shulenin, T. Nguyen, S. Venkataramani, K. L. Warfield Integrated BioTherapeutics, Gaithersburg, MD
9:00 am
S27 Heterologous Protection from Porcine Reproductive and Respiratory Syndrome Virus Infection in Swine Following Novel Vaccination J. D. Trujillo1, K. Hemnani1, T. Opriessnig2, R. Messel3, G. Tobin4, P. Nara1 1 Center for Advanced Host Defenses, Immunobiotics, and Translational Comparative Medicine, Iowa State University, Ames, IA, 2Veterinary Diagnostic and Production Animal Medicine, Iowa State University, Ames, IA, 3Immunobiotics Iowa, Ames, IA, 4 Biological Mimetics Inc, Fredrick, MD
9:15 am
S28 New Vaccine Targets to Prevent Lyme Disease M. D. Esteve-Gassent, P. Ferro, W. Mwangi College of Veterinary Medicine, Department of Veterinary Pathobiology, Texas A&M University, College Station, TX
Submitted Presentations 3B Vaccine Safety CE
Constellation Ballroom, Salon B
(Concurrent Sessions) Moderator: Georges Peter, MD
8:00 am
Warren Alpert Medical School of Brown University Brookline, MA
S29 Adverse Events Following a Third Dose of MMR Vaccine in a Mumps Outbreak, New York, 2009-2010 G. R. Abedi1, J. Mutuc1, J. Lawler2, Z. Leroy1, J. Hudson2, D. Blog3, C. Schulte3, E. Rausch-Phung3, I. Ogbuanu1, K. Gallagher1, P. Kutty1 1 CDC, Atlanta, GA, 2Orange County Department of Health, Goshen, NY, 3New York State Dept. of Health, Albany, NY
29
The Fifteenth Annual Conference PROGRAM AGENDA 8:15 am
S30 Influenza Vaccine Safety Monitoring in Pregnant Women through the Vaccine Adverse Event Reporting System (VAERS) K. R. Broder1, P. Moro1, N. Tepper1, Y. Zheteyeva1, N. Revzina1, M. Cano1, J. Arana1, F. Barash2, D. Kissin1, P. Lewis1, X. Yue1, O. Museru1, C. Vellozzi1 1 CDC, Atlanta, GA, 2FDA, Rockville, MD
8:30 am
S31 Outcomes of Infants Born to Pregnant Women Who Received Influenza A (H1N1) 2009 Live Attenuated Monovalent Vaccine: Enhanced Surveillance Using the Vaccine Adverse Event Reporting System (VAERS) P. L. Moro1, O. I. Museru1, K. Broder1, Y. Zheteyeva1, N. Tepper2, N. Revzina2, I. McCullum1, P. Lewis1, J. Arana1, F. Barash3, D. Kissin2, C. Vellozzi1 1 Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, 2Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA, 3Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD
8:45 am
S32 A Post-Licensure Evaluation of the Safety of Live Attenuated Influenza Vaccine in Children 2 to 4 and 5 to 17 Years of Age S. L. Toback1, R. Baxter2, J. Hansen2, A. Eaton2, L. Aukes2, N. Lewis2, C. S. Ambrose1 1 MedImmune, LLC, Gaithersburg, MD, 2Kaiser Permanente Vaccine Study Center, Oakland, CA
9:00 am
S33 Risk of Sexual Activity-Related Outcomes following Routine Adolescent Vaccination of 11-12 Year Olds: A Retrospective Cohort Study R. A. Bednarczyk1, R. Davis2, K. Ault3, W. A. Orenstein3, S. B. Omer3 1 Hubert Department of Global Health, Emory University, Atlanta, GA, 2Kaiser Permanente Center for Health Research-Southeast, Atlanta, GA, 3Emory University, Atlanta, GA
9:15 am
S34 Post-Licensure Monitoring of Quadrivalent Human Papillomavirus Vaccine (HPV4) (Gardasil®) Adverse Events in Males: The First Two Years of Reports to the Vaccine Adverse Event Reporting System (VAERS) T. Harrington, J. Arana, P. Lewis, G. Julianne, B. Karen, C. Vellozzi CDC, Atlanta, GA
9:30 am
Coffee Break
Symposium 5:
CE Vaccine Adjuvants
Moderator: Hana Golding, PhD Center for Biologics Evaluation and Research US Food and Drug Administration Bethesda, MD
10:00 am 16
30
How Vaccines Work Philippa Marrack, PhD Howard Hughes Medical Health Denver, CO
Constellation Ballroom, Salon A & B
on Vaccine Research PROGRAM AGENDA 10:30 am 17
11:00 am
18
11:30 am 19
Systems Vaccinology Bali Pulendran, PhD Emory Vaccine Center Atlanta, GA Vaccine Adjuvants Improve Humoral and Cellular Immunity Robert A. Seder, MD Vaccine Research Center, NIAID, NIH Bethesda, MD Rational Design and Development of New Adjuvants Steven G. Reed, PhD Infectious Disease Research Institute Seattle, WA
12:00 pm
Questions and Answers
12:30 pm
Lunch (on your own)
Symposium 6:
Scientific Assessment of Vaccine Adverse Events CE
Constellation Ballroom, Salon A & B
Moderator: Paul–Henri Lambert, MD Centre Medical Universitaire de Genéve Geneva, Switzerland 1:30 pm 20
Understanding Narcolepsy in the Context of Pandemic Influenza Vaccination Emmanuel Mignot, MD, PhD Stanford University Center for Sleep Sciences Palo Alto, CA
2:00 pm 21
Acute Viscerotropic Disease in the Context of Yellow Fever Vaccination J. Erin Staples, MD, PhD Centers for Disease Control and Prevention Fort Collins, CO
2:30 pm
22
Adverse Reactions to Squalene-Based Adjuvanted Influenza Vaccines in Special Risk Groups Claire-Anne Siegrist, MD, PD University of Geneva World Health Organization Geneva, Switzerland
3:00 pm
Questions and Answers
3:30 pm
Conference Adjourns
31
The Fifteenth Annual Conference
POSTER SESSIONS
32
on Vaccine Research POSTER SESSIONS
GENERAL POSTERS (P1-P25) P1
Advancing Vaccine Formulations to Serve Developing Countries Using New and Existing Adjuvant Technologies J. Blum, R. Cummings, D. Chen Technology Solutions, PATH, Seattle, WA
P2
WITHDRAWN
P3
Characterization of MP-12 Vaccine Encoding Toscana Virus NSs or its Mutants S. V. Indran1, O. A. Lihoradova1, I. Phoenix1, N. Lokugamage1, T. L. Juelich1, A. N. Freiberg2, T. Ikegami2 1 Pathology, University of Texas Medical Branch, Galveston, TX, 2Pathology, Sealy Center for Vaccine Design, Center for Biodefense and Emerging Infectious Diseases, University of Texas Medical Branch, Galveston, TX
P4
Deficiency of TLR3 and MyD88-Dependent Signaling Impairs T and B Cell Responses to a Live Attenuated Single Cycle Vaccine J. Xia1, E. Winkelmann2, S. Gorder1, Y. Ma1, G. Milligan1 1 Department of Microbiology and Immunology, University of Texas Medical Branch, Galveston, TX, 2 Department of Pathology, University of Texas Medical Branch, Galveston, TX
P5
Lower Antibody Levels to Staphylococcus aureus Exotoxins Are Associated with Sepsis in Hospitalized Adults with Invasive Staphylococcus aureus Infections M. Aman1, R. Adhikari1, A. O. Ajao2, H. Karauzum1, J. Sarwar1, A. Lydecker2, J. Johnson2, C. Nguyen2, W. H. Chen3, M. Roghmann2 1 Integrated BioTherapeutics, Gaithersburg, MD, 2Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, 3Department of Medicine, University of Maryland School of Medicine, Baltimore, MD
P6
DNA Priming Enhances H5N1 Influenza Vaccine Induced Neutralizing Activity by Expanding Antibody Specificity and Affinity Maturation in Humans J. Wu1, M. Dimtrova1, B. S. Graham2, J. Ledgerwood2, H. Golding1, S. Khurana1 1 CBER, Food and Drug Administration, Bethesda, MD, 2VRC, NIAID, National Institute of Health, Bethesda, MD
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The Fifteenth Annual Conference POSTER SESSIONS P7
Streptococcus Pneumonia Immunization Coverage in Elderly Hospitalized Patients in France G. Gavazzi1, G. Cherny2, C. Dupont3, A. Beauchet4, S. Gaujard5, J. Mely6, H. Guepet7, J. Gaillat8, E. Rouveix9 1 University Clinic of Geriatrics, University Hospital of Grenoble, Grenoble, France, 2Department of Internal Medicine, University Hospital A Pare, Boulogne, France, 3Department of Public Health, University Hospital A Pare, Boulogne, France, 4Department of Public Health, University Hospital A. Paré, Paris, France, 5 clinic of geriatrics, University Hospital of Antoine Charrial, Lyon, France, 6Clinic of Geriatrics, Hospital of Saint Omer, Grenoble, France, 7University Clinic of Geriatrics, University Hospital of Dijon,, Dijon, France, 8Department of Infectious Diseases, Hospital of Annecy, Annecy, France, 9Department of Internal Medicine, University Hospital A. Paré, Boulogne, France
P8
Universal Tdap Vaccination in Adults: What Healthcare Providers Know and Need to Know D. M. MacDougall1, B. A. Halperin2, D. Janowitz2, D. MacKinnon-Cameron2, J. Langley2, S. McNeil2, S. Halperin2 1 Canadian Center for Vaccinology, St. Francis Xavier University, Antigonish, Nova Scotia, Canada, 2 Canadian Center for Vaccinology, Dalhousie University, Halifax, Nova Scotia, Canada
P9
Safety, Immunogenicity, and Efficacy Studies of WRSS1, a Live Attenuated Shigella sonnei Vaccine Candidate, in Healthy Thai Adults P. Pitisuttithum1, L. Bodhidatta2, S. Chamnanchanunt3, J. Kaewkungwal4, C. Kittitagoona1, V. Luveera1, J. Dhitavat1, C. J. Mason2 1 Clinical Tropical Medicine, Mahidol University, Vaccine Trial Centre, Bangkok, Thailand, 2Armed Forces Research Institute of Medical Sciences, Bangkok, 3Clinical Tropical Medicine, Faculty of Tropical Medicine, Vaccine Trial Centre, Bangkok, Thailand, 4Mahidol University, Faculty of Tropical Medicine, Bangkok, Thailand
P10
Profile of Serum Cytokines Produced in Children with Measles Infection in Ogun State, Nigeria A. A. Adeiga, D. Faneye, J. Onyewuche, G. Akintude, T. Awoderu Microbiology, Nigerian Institute Of Medical Research Yaba, Lagos, Nigeria
P11
Novel Dengue Virus-2 Vaccines in the African Green Monkey: Safety, Immunogenicity, and Efficacy K. Nanda1, K. M. Smith1, C. J. Spears1, A. Piper2, M. Ribeiro2, M. Quiles1, G. S. Thomas3, M. E. Thomas1, D. T. Brown2, R. Hernandez2 1 Arbovax Inc., Raleigh, NC, 2Department of Molecular and Structural Biochemistry, North Carolina State University, Raleigh, NC, 3Department of Molecular Pathology, Wake Forest University, Winston-Salem, NC
P12
Coated Microstructure System for Delivery of Influenza Vaccine S. Kommareddy1, A. Bonificio1, S. Gallorini2, B. baudner2, G. Palladino1, A. Determan3, D. Dohmeier3, K. Hansen3, M. Singh1, P. R. Dormitzer1, D. O’Hagan1 1 Novartis Vaccines & Diagnostics, Cambridge, MA, 2Novartis Vaccines & Diagnostics, Siena, Italy, 33M Drug Delivery Systems, St. Paul, MN
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on Vaccine Research POSTER SESSIONS P13
PCV13 Immunogenicity and Cross Reactive Antibody Assessment Among Navajo and White Mountain Apache Infants S. E. O’Brien1, L. R. Grant1, P. Burbidge2, R. C. Weatherholtz1, J. J. Campbell1, R. Reid1, M. Santosham1, D. Goldblatt2, K. L. O’Brien1 1 Center for American Indian Health, Johns Hopkins University, Baltimore, MD, 2Institute of Child Health, University College London, London, United Kingdom
P14
Impact of 13-Valent Pneumococcal Conjugate Vaccine on a Population At High Risk For Pneumococcal Disease R. C. Weatherholtz1, L. R. Grant1, H. T. Kassa1, S. E. O’Brien1, C. Donaldson1, J. Dallas1, J. J. Campbell1, M. Harker-Jones2, K. Rudolph2, R. Reid1, M. Santosham1, K. L. O’Brien1 1 International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 2Arctic Investigations Program, Centers for Disease Control and Prevention, Anchorage, AK
P15
VRC 206: Phase I Clinical Trial of Ebola and Marburg DNA Vaccines in Healthy Adults J. E. Ledgerwood1, M. E. Enama1, P. Costner1, Z. Hu2, C. S. Hendel1, N. Sullivan1, R. Koup1, B. S. Graham1 1 VRC, NIAID, NIH, Bethesda, MD, 2BRB, DCR, NIAID, NIH, Bethesda, MD
P16
Adverse Events Following Yellow Fever Vaccination of Persons Aged 60 Years and More K. T. Miyaji, A. M. Luiz, A. N. Lara, R. O. Piorelli, T. S. Chaves, M. H. Lopes, A. M. Sartori Centro de Referência para Imunobiológicos Especiais-Divisão de Moléstias Infecciosas e Parasitárias, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil
P17
Freeze Dried Recombinant Ricin Vaccine with Long Term, High Temperature Storage Stability K. J. Hassett1, M. C. Cousins1, L. A. Rabia1, P. Nandi2, R. N. Brey3, J. M. O’Hara4, N. J. Mantis4, J. F. Carpenter2, T. W. Randolph1 1 Chemical and Biological Engineering, University of Colorado, Boulder, CO, 2Pharmaceutical Sciences, University of Colorado Denver, Aurora, CO, 3Soligenix, Princeton, NJ, 4Wadsworth Center, New York State Department of Health, Albany, NY
P18
Characterization of Rift Valley Fever MP-12 Vaccine Encoding the NSs Gene Derived from Other Phleboviruses O. A. Lihoradova1, S. V. Indran1, B. K. Kalveram1, N. Lokugamage1, T. L. Juelich1, A. N. Freiberg2, T. Ikegami2 1 Pathology, University of Texas Medical Branch, Galveston, TX, 2Pathology, SCVD, the Center for Biodefense and Emerging Infectious Diseases, University of Texas Medical Branch, Galveston, TX
P19
Knowledge and Perceptions of Nurses Regarding the Influenza Vaccination A. R. Jennings Geriatric Research Education and Clinical Center, Louis Stokes Department of Veterans Affairs Medical Center, Cleveland, OH
P20
Trypanosoma cruzi Infection-Induced Trans-sialidase-specific CD8+ T cell Memory is More Protective than that Induced by Ttrans-sialidase Vaccines in Mice J. R. Blase1, D. F. Hoft1, C. S. Eickhoff2 1 Internal Medicine and Molecular Microbiology & Immunology, Saint Louis University, Saint Louis, MO, 2 Internal Medicine, Saint Louis University, Saint Louis, MO
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The Fifteenth Annual Conference POSTER SESSIONS P21
Serologic Response to Vi Polysaccharide Vaccine in Children (2-16 Years) of an Endemic Area in Karachi, Pakistan M. Khan International Vaccine Institute, Seoul, Republic of Korea
P22
Adjuvant-Dependent Cytokine Profiles in the Context of a DNA Prime-Protein Boost HIV-1 Vaccine R. Buglione-Corbett, K. Pouliot, R. Marty-Roix, K. West, S. Wang, E. Lien, S. Lu Medicine, University of Massachusetts Medical School, Worcester, MA
P23
Immunogenicity of the Cell Culture Produced Recombinant Globular Head Domain of the Measles Virus Hemagglutinin in Mice L. M. Lobanova1, N. F. Eng1, M. Satkunarajah2, G. K. Mutwiri3, J. M. Rini2, A. N. Zakhartchouk1 1 VIDO-InterVac, University of Saskatchewan, Saskatoon, SK, Canada, 2Departments of Molecular Genetics and Biochemistry, University of Toronto, Toronto, Ontario, Canada, 3VIDO-InterVac and School of Public Health, University of Saskatchewan, Saskatoon, SK, Canada.
P24
Use of Computational Modeling to Predict Vaccine Targets: Two Examples from Staphylococcus aureus G. Pancari Microbial Vaccine Research, Merck & Co., West Point, PA
P25
Promoting Vaccination during Post-Partum Hospitalization Improves Vaccination Intention A. Gagneur1, A. Farrands1, T. Lemaitre1, L. Valiquette2, P. De Wals3, G. Petit4 1 Pediatrics, University of Sherbrooke, Sherbrooke, QC, Canada, 2Microbiology, University of Sherbrooke, Sherbrooke, QC, Canada, 3Preventive Medecine, University of Laval, Quebec, QC, Canada, 4Public Health, University of Sherbrooke, Sherbrooke, QC, Canada
TRAVEL GRANT RECIPIENTS (TG1-TG10) TG1
Exploring Enhanced Immune Responses to Synthetic Adjuvants for P.Vivax Malaria Vaccine R. Bhardwaj International Centre for Genetic Engineering and Biotechnology, New Delhi, India
TG2
Recombinant Canine Adenovirus/Rabies Virus G as a Potential Oral Vaccine for Dog Rabies Control in South Africa N. Wright1, L. H. Nel1, W. Markotter1, C. E. Rupprecht2, K. Le Roux3, M. Morters4 1 University of Pretoria, Pretoria, South Africa, 2Centers for Disease Control, Poxvirus and Rabies Branch, Atlanta, 3Allerton Veterinary Laboratories, Pietermaritzburg, South Africa, 4University of Cambridge, Cambridge, United Kingdom Willingness to Participate in Future HIV Vaccine Efficacy trials: A Case Study of Entebbe Municipality, Uganda W. L. Bakaluba AAR Health Services Uganda limited, Kampala, Uganda
TG3
36
on Vaccine Research POSTER SESSIONS TG4
Dual Positivity of Hepatitis B Surface Antigen and Anti-Hepatitis C Virus Antibody and Associated Factors among Apparently Healthy Patients of Ekiti State, Nigeria W. F. Sule, Sr.1, D. Famurewa2, J. O. Oje2, O. O. Ojo2 1 Osun State University, Osogbo, Nigeria, 2Univeristy of Ado-Ekiti, Ado-Ekiti, Nigeria
TG5
Human Immunodeficiency Virus Type-1 Infection among Children in Southwestern Nigeria A. S. Bakarey1, G. N. Odaibo1, O. O. Opaleye2, E. Donbraye3, O. M. Adewumi1, O. D. Olaleye1 1 University of Ibadan, Ibadan, Nigeria, 2Ladoke Akintola University, Osogbo, Nigeria, 3Obafemi Awolowo University, Ile-Ife, Nigeria
TG6
Occult Hepatitis B Virus Infection in Nigerian Blood Donors O. O. Opaleye Ladoke Akintola University of Technology, Ogbomoso, Nigeria
TG7
The “17D-213/77 Seed-Lot” and the “17DD Sub-Strain” of Yellow Fever Vaccine Trigger Comparable Overall Cytokine Signatures in Vaccinated Children A. Campi-Azevedo1, M. Luiza-Silva1, L. P. Pacheco1, M. A. Martins1, L. B. Camacho2, A. Homma3, A. Teixeira-Carvalho1, O. A. Martins-Filho1 1 Centro de Pesquisas René Rachou - Fiocruz, Belo Horizonte, Brazil, 2Escola Nacional de Saúde - Fiocruz, Rio de Janeiro, Brazil, 3Biomanguinhos - Fiocruz, Rio de Janeiro, Brazil
TG8
Quantification of Antibody Levels to Multiple Malaria Vaccine Candidate Antigens in Urban and Rural Areas of Ghana using a Standardized Assay E. Kyei-Baafour1, E. K. Dickson1, A. Diouf2, S. Adukpo1, J. K. Tetteh1, S. Moretz2, K. A. Koram1, B. Gyan1, C. Long2, D. Dodoo1 1 Noguchi, Memorial Institute for Medical Research, University of Ghana, Legon-Accra, Ghana, 2 Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD
TG9
Survey of Active Measles Infection in Children with Fever and Maculopapular Rash in Ogun and Lagos States,l Nigeria G. B. Akintunde Nigeria Institute of Medical Research, Lagos, Nigeria
TG10 Molecular Epidemiology of Rotavirus and Norovirus in Ile-Ife, Nigeria: Emergence of G12P[8] Rotavirus Strains and Detection of a Novel Norovirus Genotype M. O. Japhet1, O. A. Adesina1, L. Svensson2, J. Nordgren2 1 Obafemi Awolowo University (OAU), Ile-Ife, Nigeria, Ile-Ife, Osun State, Nigeria, 2Division of Molecular virology, Medical Faculty, Linköping, Linkoping University, Sweden, Linkoping, Sweden
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The Fifteenth Annual Conference
INVITED SPEAKER BIOGRAPHIES
38
on Vaccine Research INVITED SPEAKER BIOGRAPHIES
Claire-Lise Chaignat, MD, MPH Dr. Chaignat has been in charge of the WHO Global Task Force on Cholera Control and has been coordinating cholera and epidemic diarrhoeal disease surveillance, preparedness, and response activities at the global level since 2000. She was trained and specialized as a physician in internal medicine in Switzerland, and received her MPH at the Johns Hopkins Bloomberg School of Public Health, Baltimore, MD. She gained extensive field experience, mainly in Africa, when she was a medical adviser for the Swiss Humanitarian Aid Unit of the Federal Department of Foreign Affairs. She was also a scientific collaborator for the Swiss Tropical and Public Health Institute, Basel, and Director of the Support Centre for International Health in N’Djamena, Chad. Her main activities in international public health involved planning, execution, and evaluation of humanitarian aid interventions in the developing world.
Roy Curtiss III, PhD Dr. Curtiss is Professor of Life Sciences in the School of Life Sciences, and Director of the Centers for Infectious Diseases and Vaccinology and Microbial Genetic Engineering in the Biodesign Institute at Arizona State University. Previously, he was the George William and Irene Koechig Freiberg Professor of Biology and former Chair of the Department. Dr. Curtiss has also been Professor of Cellular and Molecular Biology in the School of Dental Medicine at Washington University in St. Louis. Earlier in his career, he served as biologist and group leader in the Biology Division at Oak Ridge National Laboratory; Professor, Associate Director, and Interim Director of the University of Tennessee-Oak Ridge Graduate School of Biomedical Sciences; and Charles H. McCauley Professor of Microbiology at the University of Alabama in Birmingham, where he was Founder and Director of the NIH/NSF funded Molecular Cell Biology Graduate Program. Dr. Curtiss was also Founder and Director of the first Cystic Fibrosis Research Center at a US university. He received his BS from Cornell
University and PhD from the University of Chicago. Dr. Curtiss is a Fellow of the American Academy of Microbiology, the American Association for the Advancement of Science, the St. Louis Academy of Sciences and the Arizona Arts, Science and Technology Academy and is a member of the National Academy of Sciences. Dr. Curtiss was granted the first US patent issued for a genetically modified (micro)organism (1776). He holds the first patent on genetically engineered attenuated bacteria to deliver protective antigens as vaccines to prevent infectious diseases, and holds the first patents (with Guy Cardineau) on genetically modified plants expressing pathogen-derived protective antigens as vaccines against bacterial and viral pathogens. Dr. Curtiss was also Missouri Inventor of the Year in 1997 and Arizona Bioscience Researcher of the Year in 2007. Past research includes vegetable and avian genetics, phage and bacterial genetics, plasmid molecular biology and genetics, and molecular biology of bacterial pathogens. Current research focuses on design, construction, and evaluation of recombinant attenuated Salmonella vaccines to prevent infectious diseases, host immune responses to infection and vaccination, and research on molecular genetics and redesign of cyanobacteria for production of biofuels.
Suzanne L. Epstein, PhD Dr. Epstein received her BA in chemistry from Harvard University in 1972, and her PhD in biology from MIT in 1979, with thesis work in immunology. She did postdoctoral research in immunology at the National Cancer Institute. In 1985, she came to the FDA Center for Biologics Evaluation and Research as a researcherreviewer. She currently serves as Associate Director of Research for the Office of Cellular, Tissue, and Gene Therapies, a research management role, in addition to her work in research and regulatory review. Her FDA regulatory responsibilities have included review of investigational new drug (IND) applications
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The Fifteenth Annual Conference INVITED SPEAKER BIOGRAPHIES in multiple areas including cellular and gene therapies, service on a licensing committee and inspection team, and policy development in cell and gene therapy. Since 1991 her research at CBER has been in the field of immunity to influenza virus infection. Her lab is studying “universal” vaccinations in animal models that use conserved antigens to protect broadly against influenza A viruses, including avian H5N1 strains, and swine-origin flu. The group explores mechanisms of such cross-protective immunity, including systemic and mucosal antibody and T cell responses. This type of vaccine strategy does not require advance strain identification or prediction, and so could fill public health gaps during unexpected outbreaks and pandemics.
Thomas M. File, Jr., MD, MS Dr. File is Chief of the Infectious Disease Service, and Director of HIV Research at Summa Health System in Akron, OH, and Professor of Internal Medicine, Master Teacher, and Head of the Infectious Disease Section at the Northeastern Ohio Universities College of Medicine in Rootstown, OH. After graduating from medical school at the University of Michigan, Ann Arbor, in 1972, Dr. File received his Master of Science in medical microbiology from Ohio State University in Columbus in 1977, where he also completed his fellowship in infectious diseases. Dr. File is a Master of the American College of Physicians, a Fellow and member of the Board of Directors of the Infectious Diseases Society of America (IDSA), and a fellow of the American College of Chest Physicians. He is President-elect of the National Foundation for Infectious Diseases (NFID), and is a member of many other professional societies, including the American Society for Microbiology, the American Thoracic Society (ATS), and the American Society of Hospital Epidemiologists. He is past-Chair of the Standards and Practice Guidelines Committee of IDSA and has served as a member of the IDSA and ATS committees for guidelines on community-acquired pneumonia. Additionally, Dr. File is a member of 40
the IDSA guidelines panels for hospital-acquired pneumonia, influenza, and sinusitis. He is pastpresident of the Infectious Disease Society of Ohio, and is a past-president of the Northeastern Ohio Task Force on AIDS. Dr. File’s primary research interests include community-acquired respiratory tract infections, immunizations in adults, bacterial resistance in respiratory infections, infections in patients with diabetes, soft tissue infections, and evaluation of new antimicrobial agents. A frequent lecturer both nationally and internationally, Dr. File has published more than 200 articles, abstracts, and textbook chapters focusing on the diagnosis, etiology, and treatment of infectious diseases, with a focus on respiratory tract infections. He co-authored File TM Jr. and Stevens DL Contemporary Diagnosis and Management of Skin and Soft Tissue Infections, 2nd Ed (2007, published by Handbooks in Health Care Co.) and co-edited Tan JS, File TM Jr., Salata RA, Tan MJ (eds.) Expert Guide to Infectious Diseases, 2nd edition (2008, published by ACP Press, Phil.). In addition, he is Editor-in-Chief of the journal Infectious Diseases in Clinical Practice.
Roger I. Glass, MD, PhD Dr. Glass was named Director of the Fogarty International Center and Associate Director for International Research at the National Institutes of Health (NIH) in 2006. Dr. Glass graduated from Harvard College in 1967, received a Fulbright Fellowship to study at the University of Buenos Aires in 1967, and received his MD from Harvard Medical School. In 1972, Dr. Glass received his MPH from the Harvard School of Public Health. He joined the Centers for Disease Control and Prevention in 1977 as a medical officer and was assigned to the Environmental Hazards Branch. He was also a scientist at the International Center for Diarrheal Disease Research in Bangladesh from 1979-1983, after which he returned to Sweden
on Vaccine Research INVITED SPEAKER BIOGRAPHIES where he received his doctorate from the University of Goteborg. In 1984, he joined the NIH Laboratory of Infectious Diseases, where he worked on the molecular biology of rotavirus. In 1986, Dr. Glass returned to the CDC to become Chief of the Viral Gastroenteritis Unit at the National Center for Infectious Diseases. Dr. Glass’ research interests focus on the prevention of gastroenteritis from rotaviruses and noroviruses through the application of novel scientific research. He has maintained field studies in India, Bangladesh, Brazil, Mexico, Israel, Russia, Vietnam, China, and elsewhere around the world. His research has been targeted toward epidemiologic studies to anticipate the introduction of rotavirus vaccines. He is fluent, and often lectures, in five languages. Dr. Glass has received numerous awards including the prestigious Charles C. Shepard Lifetime Scientific Achievement Award presented by the CDC in recognition of his 30-year career of scientific research application and leadership, and the Dr. Charles Mérieux Award from the National Foundation for Infectious Diseases for his work on rotavirus vaccines in the developing world. He is a member of the Institute of Medicine of the US National Academies of Science. Dr. Glass has co-authored more than 500 research papers and chapters. He is married to Barbara Stoll, MD, the George W. Brumley, Jr. Professor and Chair of the Department of Pediatrics at Emory University School of Medicine, and the Medical Director of the Children’s Healthcare of Atlanta at Egleston. He and his wife have three children.
F. Marc LaForce, MD Dr. LaForce served as Director of the Meningitis Vaccine Project, a PATH/WHO partnership, from 2001 to 2012. He earned his degree in medicine from Seton Hall College of Medicine and Dentistry, NJ, and completed his internal medicine and infectious disease training on the Harvard Service at Boston
City Hospital. He is board-certified in internal medicine and infectious diseases and is a Fellow of the American College of Physicians and the Infectious Diseases Society of America. Dr. LaForce served as Epidemic Intelligence Service officer in the Meningitis and Special Pathogen units at the Centers for Disease Control and Prevention (CDC). He has held research and academic positions at the Universities of Colorado and Rochester Schools of Medicine. Dr. LaForce has served on the CDC’s Advisory Committee on Immunization Practices, the ACP Committee on Adult Immunizations, and was President of the Armed Forces Epidemiological Board from 1999-2001. From 1995 to 2001, Dr. LaForce chaired WHO’s Global Programme on Vaccines Steering Committee on Epidemiology and Field Research. He has published over 200 papers and book chapters in the areas of pulmonary defense mechanisms, clinical infectious diseases, epidemiology, and vaccinology. Dr. LaForce is the 2012 Albert B. Sabin Gold Medal Award Recipient.
Philippa Marrack, PhD Dr. Marrack completed undergraduate and postgraduate degrees at New Hall, Cambridge, England, and postdoctoral work at the University of California at San Diego. She worked at the University of Rochester, NY, and is currently an Investigator at the Howard Hughes Medical Institute and a Distinguished Professor at National Jewish Health and the University of Colorado Denver. In 1967, Dr. Marrack began to work on T cells, crucial cells of the immune system which had been discovered independently by Drs. Miller and Good a few years earlier. In collaboration with her husband, Dr. John Kappler, Dr. Marrack discovered how T cells act to help other cells reject infections and how T cells distinguish between invading organisms and their own host. These investigators also showed that some bacteria and viruses are particularly damaging because they produce powerful stimulants of the immune system which, paradoxically, kill rather than
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The Fifteenth Annual Conference INVITED SPEAKER BIOGRAPHIES protect their hosts. Recently Dr. Marrack has been studying adjuvants; crucial components of human and animal vaccines. Dr. Marrack is a member of the Royal Society, the National Academy of Sciences, and the Institute of Medicine. Her numerous awards include: Royal Society Wellcome Foundation Prize; Paul Ehrlich and Ludwig Darmstädter Prize; Louisa Gross Horwitz Prize-Columbia University; Rabbi Shai Shackner PrizeUniversity of Jerusalem; Lifetime Achievement Award of the American Association of Immunologists; and L’Oreal UNESCO Women in Science Award.
John J. Maurer, PhD Dr. Maurer is a research microbiologist at the Poultry Diagnostic Research Center (PDRC), University of Georgia. He is Professor of Population Health, adjunct professor in the Department of Microbiology, and member of the Center for Safety at the University of Georgia. His laboratory primarily focuses on food safety working on a broad range of topics including molecular epidemiology of foodborne pathogens, developing and validating rapid detection methods, and microbial ecology of the intestinal tract. Dr. Maurer received his PhD degree from the University of Texas Health Science Center at San Antonio. He received three years of postdoctoral training in Dr. Roy Curtiss’ lab at Washington University in St. Louis. In 1996, Dr. Maurer joined the faculty at PDRC. He has over 50 publications in high impact journals including: Proceedings of the National Academy of Sciences USA, Journal of Bacteriology, Journal of Clinical Microbiology, Antimicrobial Agents & Chemotherapy, Applied & Environmental Microbiology, and BMC Microbiology. Dr. Maurer has served on several national committees addressing food safety issues including the recent review by the Institute of Medicine on proposed changes in food inspections by the USDA.
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Emmanuel Mignot, MD, PhD Dr. Emmanuel Mignot is Director of the Stanford Center for Sleep Sciences and Professor of Psychiatry and Behavioral Sciences. He is internationally recognized as having discovered the cause of narcolepsy and also directs the Center for Narcolepsy. Dr. Mignot is a former student of the Ecole Normale Superieure (Ulm, Paris, France). He received his MD and PhD from Paris V and VI University in France. Dr. Mignot practiced medicine and psychiatry in France for several years before serving as a visiting scholar at the Stanford Sleep Disorders Clinic and Research Center. He joined as faculty and Director of the Center for Narcolepsy in 1993. He was named Professor of Psychiatry in 2001 and Director of the newly established Stanford Center for Sleep Sciences in 2010. Dr. Mignot has received numerous research grants and honors, including National Sleep Foundation and National Institute of Health Research Awards, Howard Hughes Medical Institute Investigator and McKnight Neuroscience awards, the Narcolepsy Network professional service award, the Drs. C. and F. Demuth 11th Award for Young Investigators in the Neurosciences, the WC Dement Academic Achievement Award in sleep disorders medicine, the CINP and ACNP awards in neuropharmacology, and the Jacobaeus prize. He is an elected member of the Association of American Physicians and of the Institute of Medicine of the National Academy of Sciences. Dr. Mignot is also the co-author of more than 200 original scientific publications and he serves on the editorial board of scientific journals in the field of sleep and biology research. Dr. Mignot is an active member of several professional and governmental organizations. He is past president of the Sleep Research Society, chair of the National Center on Sleep Disorders Research Advisory Board of the National Institutes of Health, and chair of the Board of Scientific Counselors of the National Institute of Mental Health.
on Vaccine Research INVITED SPEAKER BIOGRAPHIES Most of his current research focuses on the neurobiology, genetics, and immunology of narcolepsy, a disorder caused by hypocretin (orexin) cell loss, with indirect interest in the neuroimmunology of other brain disorders. His laboratory uses state of the art human genetics and immunology techniques, such as genome wide association, exome or whole genome sequencing in the study of human sleep and sleep disorders, and antigen presentation studies with parallel studies in animal models.
Arnold S. Monto, MD Dr. Monto is the Thomas Francis Jr. Collegiate Professor of Epidemiology at the University of Michigan, School of Public Health in Ann Arbor. The major focus of his work has been the epidemiology, prevention, and treatment of acute infections in the individual and the community. Respiratory infections, in particular influenza, have been a major interest, with special reference to the evaluation of vaccines in various populations and the assessment of the value of antivirals. He has worked on these issues in tropical as well as temperate regions. Dr. Monto led the studies of respiratory infection in Tecumseh, MI, a landmark study of infection in the community. He has studied various approaches to influenza vaccine use, particularly to control transmission of the virus in the community and in nursing homes. Dr. Monto is involved in assessing the efficacy of various types of influenza vaccine in prophylaxis and neuraminidase inhibitors, and other compounds in prophylaxis and therapy of influenza, including implications of antiviral resistance. He now heads an observational study of effectiveness of influenza vaccines in various settings. His recent activities have included evaluation of face masks and hand hygiene in the control of influenza transmission and determination of efficacy of the traditional inactivated and live attenuated influenza vaccines. He works extensively with national and international
organizations on issues related to pandemic preparedness. Dr. Monto has been a member of the Pulmonary Diseases Advisory Committee and the National Allergy and Infectious Disease Advisory Council of the US National Institutes of Health, and is now on the Scientific Advisory Board of the Fondation Mérieux. He is a past-president of the American Epidemiological Society and the 2009 recipient of the Alexander Fleming Award of the Infectious Diseases Society of America for lifetime achievement. He was a member of the Emergency Committee where he made recommendations to the World Health Organization during the past influenza pandemic.
Peter L. Nara, MS, DVM, PhD* (*Meet the Experts Breakfast Speaker) Dr. Nara is currently Chief Executive Officer, President, Chair, and Co-Founder of Biological Mimetics, Inc., a biotechnology company founded to translate the theory of “Deceptive Imprinting” and the first ever Rational Antigen Design technology, “Immune Refocusing,” discovered by Dr. Nara and colleagues, into preventative vaccines, novel immunotherapeutics, and diagnostics in both human and veterinary medicine. Dr. Nara was previously the Section Chief of the Vaccine Resistant Diseases Section, Division of Basic Sciences, Office of the Director at the National Cancer Institute, National Institutes of Health. Dr. Nara holds the Eugene Lloyd Endowed Chair in Vaccinology, is a professor in the Department of Biomedical Sciences, and is the Founding Director for the Center of Advanced Host Defenses, Immunobiotics, and Translational Comparative Medicine at the College of Veterinary Medicine, Iowa State University. Dr. Nara’s scientific contributions include over 21 book chapters and 163 scientifically peer-reviewed publications. His accomplishments include: laboratory at the National Cancer Institute was designated
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The Fifteenth Annual Conference INVITED SPEAKER BIOGRAPHIES both a National and International AIDS Reference Laboratory by the National Institute of Allergy and Infectious Diseases and World Health Organization (WHO) Global Program on AIDS; initiated an international effort which characterized over 120 HIV-1 isolates for future vaccine and clinical trial site development from epidemic centers around the world; laboratory was designated the first of five HIV-1 Immunotyping laboratories; and served as group leader and chair for the WHO Network for HIV Isolation and Characterization. He consults and serves on numerous scientific advisory boards of corporate, private foundations, and academic initiatives in the area of national biodefense, comparative medicine and immunology, vaccine discovery, and immunotherapeutics, and is a recent member of the US State Department Bio-Industry Initiative Program, the civilian Research and Development Foundation (CDRF), and the International Science and Technology Center (ISTC) for non-proliferation of biological agents. Dr. Nara’s formal education and training include a Bachelor of Science received in 1977 from Colorado State University; a Master of Science in immunopharmacology received in 1979 from The Ohio State University; and a combined Doctor of Veterinary Medicine in 1984 and Doctorate of Philosophy in Retrovirology and Immunology received in 1986 from The Ohio State University. After graduating from veterinary school, he received a combined four year National Institutes of Health (NIH) medical post-doctoral fellowship at the National Cancer Institute and a four year Comparative Pathology Residency at the Armed Forces Institute of Pathology in Washington, DC from 1986 to 1990. He was acting head and cancer virus expert of the Virus Biology Section in the Office of the Institute’s Director from 1990-1992 and was tenured and promoted to Section Chief of the Vaccine Resistant Diseases Section from 1993-1998. Most importantly, he is the dedicated husband of 34 years to Brenda Nara, the father to four beautiful daughters, and grandfather to three incredible grandchildren.
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Kathleen M. Neuzil, MD, MPH Dr. Neuzil is a Senior Clinical Advisor for Vaccines and the Director of the Influenza Vaccine Project at PATH, a global health non-profit organization headquartered in Seattle, WA. The focus of her work at PATH is to generate evidence that will influence global vaccine policy, and to advance development of promising vaccines that can be accessible and affordable to people in low-resource countries. Dr. Neuzil led the three pivotal randomized, controlled trials of rotavirus vaccines in developing countries that informed the global policy. Dr. Neuzil is a Clinical Professor in the Departments of Medicine and Global Health at the University of Washington, where she continues to teach and mentor students, fellows, and junior faculty. Dr. Neuzil has served on a number of vaccine policy committees, including 11 years of service to CDC’s Advisory Committee on Immunization Practices as a liaison representative and voting member from 2000 until present. Dr. Neuzil was a member of the World Health Organization’s Diarrheal and Enteric Vaccines Advisory Committee from 2006 to 2010. Dr. Neuzil graduated Summa cum laude with a Bachelor of Science degree in Zoology from the University of Maryland; received her MD degree from the Johns Hopkins University School of Medicine, and was awarded a Masters in Public Health from Vanderbilt University. Dr. Neuzil completed her Internal Medicine residency and Infectious Disease Fellowship at Vanderbilt University. Dr. Neuzil has authored or co-authored over 120 publications on vaccines and infectious disease-related topics.
Christian F. Ockenhouse, MD, PhD Dr. Ockenhouse is a malariologist-vaccinologist and board certified physician in internal medicine and infectious diseases at the Walter Reed Army Institute of Research (WRAIR). He is a Colonel in US Army and is the Director of the Malaria Vaccine Branch in the Military Malaria Research Program at the WRAIR. The WRAIR is the US military’s preeminent institution for
on Vaccine Research INVITED SPEAKER BIOGRAPHIES bringing infectious disease and public health solutions to benefit both the soldier and global public health and leads the international community in developing malaria vaccines. Dr. Ockenhouse received in MS degree in Parasitology and Public Health from the Tulane University School of Public Health & Tropical Medicine in New Orleans, his PhD in Immunology and Parasitology from New York University, and his MD degree from the Medical College of Pennsylvania in Philadelphia. He completed residencies in internal medicine and infectious diseases at the Walter Reed Army Medical Center in Washington, DC. His research has focused primarily on translational medicine by developing subunit malaria vaccine candidates for formulation with novel adjuvants for GMP manufacturing and initial phase 1/2a clinical studies. He has worked on optimizing human challenge models of both P. falciparum and P. vivax malaria to evaluate the protective efficacy after immunization and compare the immune response to identify correlates of protection. His basic research interests are concentrated in the area of receptorligand interactions in malaria parasite adhesion and invasion of host cells where he has published extensively.
Umesh Parashar, MBBS Dr. Parashar is the Lead of the Enteric Viruses Epidemiology Team in the Division of Viral Diseases at the US Centers for Disease Control and Prevention (CDC). Dr. Parashar completed medical school in India and then completed postgraduate training in Public Health and Preventive Medicine in the United States. He joined the CDC as an Epidemic Intelligence Service Officer in 1996 and has spent more than 15 years at CDC researching the epidemiology of viral gastroenteritis and methods for its prevention and control, including vaccination strategies against rotavirus gastroenteritis. Dr. Parashar was the CDC co-lead of the working group that developed the
recommendations for use of the new rotavirus vaccines in the US. The CDC Enteric Viruses Team also leads the Disease Burden and Surveillance Activities of the Rotavirus Vaccine Program (RVP), a partnership between the CDC, World Health Organization, and Program for Applied Technology in Health that is supported by the Global Alliance for Vaccines for Immunization. The RVP conducted activities to accelerate introduction of rotavirus vaccines in developing countries with the greatest burden of rotavirus disease. Dr. Parashar has published more than 200 scientific papers and book chapters, and has given numerous peer-reviewed presentations at prominent scientific conferences. He has also served as guest editor on four supplements for leading scientific journals and on advisory committees to the World Health Organization. He has received several awards, including the Oswald Avery Award for Early Achievement from the Infectious Disease Society of America, the Shepard Award for Best Scientific Paper in the Prevention and Control Category from the CDC in 2009, and six awards for Distinguished Service from the Secretary of the US Department of Health and Human Services.
Daniel R. Perez, PhD Dr. Perez obtained his BS in Biochemistry from the National University of Cordoba, Argentina in 1989, and completed his PhD in Molecular Virology in the Department of Veterinary and Biomedical Sciences at the University of Nebraska, Lincoln, in 1995. In March 2000, Dr. Perez joined the laboratory of Dr. Robert Webster at St. Jude Children’s Research Hospital where he worked on biological and epidemiological aspects of avian influenza viruses. He is currently an Associate Professor in the Department of Veterinary Medicine at the University of Maryland, College Park. Dr. Perez has been studying virus-virus and virus-host protein interactions of influenza virus and bovine viral diarrhea virus. His current interests include the interspecies transmission, pathogenesis
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The Fifteenth Annual Conference INVITED SPEAKER BIOGRAPHIES and evolution of avian influenza viruses, and the role of cross-protective immunity in the spread of highly pathogenic avian influenza viruses to other birds and mammals. Among Dr. Perez’s major scientific contributions has been the participation in the development of the first plasmid-based reverse genetics system for influenza, which allows the complete manipulation of the influenza genome. Such strategy has proven instrumental in the preparation of vaccines for pandemic preparedness, particularly against the current H5N1 and H9N2 viruses. Using reverse genetics and classical virology, Dr. Perez studies are aimed at better characterizing intermediate hosts as contributors in the adaptation, spread, and perpetuation of novel avian influenza variants that can be transmitted to other poultry and mammals, including humans. Dr. Perez is currently heading a major research project with the collaboration of 17 other institutions across the US and funded by the USDA. This six year project with over $10 million in funding entitled “Prevention and Control of Avian Influenza in the US” is the largest granted by the USDA to combat a single disease. Dr. Perez’s lab is also a member of the NIAID-funded Center for Research on Influenza Pathogenesis, in collaboration with Mount Sinai School of Medicine, Erasmus Medical Center, and University of WisconsinMadison, and other research partners.
Stanley A. Plotkin, MD Dr. Plotkin is Emeritus Professor of the University of Pennsylvania, and Adjunct Professor of the Johns Hopkins University. Until 1991, he was Professor of Pediatrics and Microbiology at the University of Pennsylvania, Professor of Virology at the Wistar Institute and at the same time, Director of Infectious Diseases and Senior Physician at the Children’s Hospital of Philadelphia. In 1991, Dr. Plotkin left the University to join the vaccine manufacturer, PasteurMérieux-Connaught, where for seven years he was Medical and Scientific Director, based at Marnes-la46
Coquette, outside Paris. The same company is now named sanofi pasteur. He is consultant to vaccine manufacturers, biotechnology companies, and non-profit research organizations as principal of Vaxconsult, LLC. Dr. Plotkin attended New York University, where he received a BA degree, and the State University of New York Medical School in Brooklyn, where he received his MD in 1956. His subsequent career included an internship at Cleveland Metropolitan General Hospital, residency in pediatrics at the Children’s Hospital of Philadelphia, and the Hospital for Sick Children in London, and three years in the Epidemic Intelligence Service of the Centers for Disease Control of the US Public Health Service. He has been chairman of the Infectious Diseases Committee and the AIDS Task Force of the American Academy of Pediatrics, liaison member of the Advisory Committee on Immunization Practices and Chairman of the Microbiology and Infectious Diseases Research Committee of the National Institutes of Health. Dr. Plotkin received the Bruce Medal in Preventive Medicine of the American College of Physicians, the Distinguished Physician Award of the Pediatric Infectious Diseases Society, the Clinical Virology Award of the Pan American Society for Clinical Virology, the Richard Day Master Teacher in Pediatrics Award of the Alumni Association of New York Downstate Medical College, and the Marshall Award of the European Society for Pediatric Infectious Diseases. In June 1998, he received the French Legion of Honor Medal. In June 2001, he received the Distinguished Alumnus Award of the Children’s Hospital of Philadelphia, and in September 2006 he later received the gold medal from the same hospital. Other awards include the Sabin Gold Medal in 2002; Fleming (Bristol) Award of the Infectious Diseases Society of America in 2004; the medal of the Fondation Mérieux in 2007; and in 2009, he received both the Maxwell Finland Award of the National Foundation for Infectious Diseases and Hilleman Award of the American Society for Microbiology.
on Vaccine Research INVITED SPEAKER BIOGRAPHIES He was elected to the Institute of Medicine of the National Academy of Sciences in 2005 and to the French Academy of Medicine in 2007. Dr. Plotkin holds honorary doctoral degrees from the University of Rouen (France) and the Complutense University of Madrid (Spain). Named lectures in his honor have been established at the Pediatric Academic Societies annual meeting and at the International Advanced Vaccinology Course in Annecy, France. A professorship in his name was established at the Children’s Hospital of Philadelphia. His bibliography includes over 700 articles and he has edited several books including the standard textbook on vaccines, now in its 5th edition. He developed the rubella vaccine now in standard use throughout the world, is co-developer of the newly licensed pentavalent rotavirus vaccine, and has worked extensively on the -development and application of other vaccines including anthrax, oral polio, rabies, varicella, and cytomegalovirus.
Gregory A. Poland, MD* (*Meet the Experts Breakfast Speaker) Dr. Poland is the director of Mayo Clinic’s Vaccine Research Group – a state-of-the-art research group and laboratory that investigates issues surrounding vaccine response and novel vaccines important to public health. He is a professor of Medicine and Infectious Diseases, the director of the Immunization Clinic, and director of the Program in Translational Immunovirology and Biodefense at the Mayo Clinic. Dr. Poland was awarded the Secretary of Defense Award for Excellence in December 2008. In 2008, he was named a Master of the American College of Physicians. Dr. Poland received the Hsu prize in International Infectious Disease Epidemiology in 2007, and the Charles Merieux Lifetime Achievement Award in Vaccinology from NFID in May 2006. In December 2006, Dr. Poland was elected President of the Defense Health Board, serving two terms, and currently serves as the Vice-President and advisor on pandemic influenza issues to the Secretary of Defense. In 2005 he was awarded an honorary Doctor of Humane Letters by Illinois Wesleyan University, his alma mater.
He was appointed as the Mary Lowell Leary Professor in Medicine (the highest academic distinction for a faculty member) by Mayo Clinic’s Board of Trustees in 2004. In May 2003, he was awarded the Secretary of Defense Medal for Outstanding Public Service. Since 2004, Dr. Poland has served on the Infectious Diseases Society of America Taskforce on Pandemic Influenza, and chaired the American College of Physician’s Adult Immunization Advisory Board. Dr. Poland received the inaugural Gold Medal from the Spanish Vaccinology Society in 2001. In 1998, he received a joint award from the CDC and the Health Care Financing Administration for his contribution to increasing adult immunization rates in the U.S. which was awarded by the Surgeon General of the United States. In 1997, he was honored as the “Outstanding Clinical Investigator of the Year” by Mayo Clinic. He is the immediate past President of the International Society for Vaccines, and is the current president and co-founder of the Edward Jenner Society. Dr. Poland participates on many national and academic review committees and actively peer-reviews journal articles for over 26 different publications including The Lancet, Annals of Internal Medicine, and New England Journal of Medicine. A prolific writer, Dr. Poland has published over 350 peerreviewed scientific articles and book chapters.
Andrew J. Pollard, PhD Dr. Pollard is Professor of Pediatric Infection and Immunity at the University of Oxford, Director of the Oxford Vaccine, James Martin Senior Fellow, Jenner Institute Investigator, Fellow of the Infectious Disease Society of America, Fellow of St. Cross College, and Honorary Consultant Pediatrician at the Children’s Hospital, Oxford, UK. He obtained his medical degree at St Bartholomew’s Hospital Medical School, University of London in 1989, and trained in Pediatrics at Birmingham Children’s Hospital, UK, specializing in Pediatric Infectious Diseases at St Mary’s Hospital, London, UK, and at British Columbia Children’s Hospital, Vancouver, Canada. He obtained his PhD at St. Mary’s Hospital, London, UK in 1999, studying
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The Fifteenth Annual Conference INVITED SPEAKER BIOGRAPHIES immunity to Neisseria meningitidis in children and proceeded to work on anti-bacterial innate immune responses in children in Canada before returning to his current position at the University of Oxford, UK in 2001. Dr. Pollard chaired the UK’s NICE meningitis guidelines development group and chairs the NICE topic expert group developing quality standards for management of meningitis and meningococcal septicemia. He sits on the Department of Health committee that considers use of meningococcal vaccines. He runs one of the largest pediatric research groups in the UK with 70 staff. Current research activities include clinical trials of new and improved vaccines for children, surveillance of invasive bacterial diseases in children in Nepal, studies of cellular and humoral immune responses to glycoconjugate and typhoid vaccines, and development of a serogroup B meningococcal vaccine. His publications include over 200 manuscripts and books on various topics in pediatrics, infectious diseases, and high altitude medicine.
recently established National Centre of Excellence in Commercialization and Research. Dr. Potter has served on a number of public and private sector committees and Boards, and has been instrumental in transferring VIDO technology from the laboratory to the private sector. He is a Fellow of the Canadian Academy of Health Sciences.
Bali Pulendran, PhD Dr. Bali Pulendran is a Charles Howard Candler Professor of Pathology and Laboratory Medicine, and Director of the Innate Immunity Program, and the NIH U19 Center for Systems Vaccinology, at the Emory Vaccine Center, Emory University in Atlanta. He received his undergraduate degree (BA Hons) from Cambridge University, and his PhD from the Walter & Eliza Hall Institute, in Melbourne Australia, under the supervision of Sir Gustav Nossal. He then did his postdoctoral work at Immunex Corporation in Seattle.
Dr. Andrew Potter is a graduate of Carleton University (Canada) and the University of Otago (New Zealand), and has worked at the Vaccine and Infectious Disease Organization/ International Vaccine Centre (VIDO/ InterVac), University of Saskatchewan, for the past 26 years serving as a research scientist, Associate Director (Research), and more recently, Director and Chief Executive Officer. He is also a Professor of Veterinary Microbiology at the Western College of Veterinary Medicine.
Dr. Pulendran’s work focuses on understanding the mechanisms by which the innate immune system regulates adaptive immunity and harnessing such mechanisms in the design of novel vaccines against global pandemics. More recently, he has begun to apply systems biological approaches to predicting the efficacy of vaccines and deciphering new correlates of protection against infectious diseases. Dr. Pulendran’s research is published in front line journals such as Nature, Science, Cell, Nature Medicine, Nature Immunology, Immunity, The New England Journal of Medicine, Proceedings of the National Academy of Sciences USA, and The Journal of Experimental Medicine.
His primary research interests are in the areas of the pathogenesis of bacterial respiratory diseases and the development of vaccines for zoonotic diseases. He has mentored more than 49 graduate students and post-doctoral fellows who currently hold positions in industry, academia, and government worldwide. He previously worked for the Governments of Canada and the Philippines and served as the CEO of the Pan-Provincial Vaccine Enterprise (PREVENT), a
Dr. Pulendran is the recipient of numerous grants from the National Institutes of Health and from The Bill and Melinda Gates Foundation, serves on the editorial boards of The Journal of Clinical Investigation and The Journal of Immunology, serves on the Aids Vaccine Research Subcommittee, and is frequently speaker at national and international conferences. Dr. Pulendran is the recipient of two concurrent MERIT awards from the National Institutes of Health, as well as the 2011
Andrew A. Potter, PhD
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on Vaccine Research INVITED SPEAKER BIOGRAPHIES Albert E. Levy Award, 2011 Paper of the year award by the International Society for Vaccines.
Steven G. Reed, PhD Dr. Reed is the Founder, President, and CSO of the Infectious Disease Research Institute (IDRI). His academic appointments include Professor of Medicine at Cornell University Medical College in New York and Research Professor of Pathobiology at the University of Washington. He serves on several editorial review committees, has served as a member of the Tropical Medicine Review Board of the National Institutes of Health, and is a member of the Vaccine Development Steering Committee of the World Health Organization. Dr. Reed received a PhD in Microbiology and Immunology from the University of Montana in 1979. That year he was appointed as Scientist of the National Institute of Amazon Research in Manaus, Brazil, where he directed research on tropical diseases. Dr. Reed joined Cornell University Medical College in 1980 as Assistant Professor of Medicine, continuing to work in Brazil as manager of the CornellBahia program in International Medicine. He joined the Seattle Biomedical Research Institute in 1984 where he worked until founding IDRI in 1993. In 1994, he co-founded Corixa Corporation (which was later sold to GlaxoSmithKline, GSK) where he served as Chief Scientific Officer until leaving in 2004. He also founded Dharma Therapeutics, where he served as President from 2005-2008. In 2008, Dr. Reed founded Immune Design Corp. and currently serves on the Board of Directors. Dr. Reed’s research interests have focused on the immunology of intracellular infections and on the development of vaccines and diagnostics for both cancer and infectious diseases. He led the team that, together with GSK, developed the first defined tuberculosis vaccine to advance to clinical trials, and has developed the first defined vaccine for leishmaniasis, as well as the K39-based diagnostic tests currently licensed for leishmaniasis. He has more than 225 original publications, 35 book chapters
and reviews, and 105 issued patents on diagnostics, vaccines, and therapeutics of infectious diseases and cancer.
CAPT Stephen J. Savarino, MD, MPH Dr. Stephen Savarino is Head of the Enteric Diseases Department at the Naval Medical Research Center in Silver Spring, MD. He also serves as Research Coordinator of the Diarrheal Diseases Prevention Research Program Area for the US Military Infectious Diseases Research Program at the US Army Medical Research and Materiel Command. Dr. Savarino has worked in the fields of bacterial diarrhea pathogenesis and prevention for almost 25 years, performing research that spans the gamut from bench to field evaluation of new vaccines against enteric bacteria. This included a tour as Director of Field Research at the Naval Medical Research Unit No. 3, Cairo, Egypt where he led a five-year project assessing the safety and efficacy of a killed, oral enterotoxigenic E. coli (ETEC) vaccine in Egyptian children. Dr. Savarino is currently the Principal Investigator on Army, NIAID, and industry funded grants to develop new generation vaccines against travelers’ diarrhea by understanding and foiling the molecular events that occur upon initial contact between host and pathogen. He has authored over 50 scientific papers on bacterial pathogenesis, epidemiology, and vaccinology. Dr. Savarino obtained his BA degree in Biochemical Sciences cum laude from Harvard College and his MD and MPH jointly from Boston University School of Medicine and the Harvard School of Public Health. After completing his pediatrics internship and residency at the National Naval Medical Center and Duke University, respectively, he trained in infectious diseases and tropical pediatrics at the University of Maryland School of Medicine. Dr. Savarino holds joint appointments as Associate Professor of Pediatrics and Adjunct Assistant Professor of Emerging Infectious Diseases at the Uniformed Services University of the Health Sciences, Bethesda, MD. He entered the Navy in 1980 through the Naval Health Professions Scholarship Program. He is the recipient of the
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The Fifteenth Annual Conference INVITED SPEAKER BIOGRAPHIES Meritorious Service Medal, and the Ogden Bruton and Andrew Margileth Awards for outstanding basic and clinical research from the Uniformed Services Section of the American Academy of Pediatrics.
Robert A. Seder, MD Dr. Seder is an immunologist and is board certified in internal medicine with fellowship training in allergy/immunology. He is currently Chief, Cellular Immunology Section, Vaccine Research Center, NIH. His laboratory focuses on T cell differentiation and memory and understanding the cellular and molecular mechanisms by which vaccine vectors and immune adjuvants mediate humoral and cellular immunity. The goal of his laboratory is to translate basic discoveries toward development of vaccines against HIV, malaria, and tuberculosis. Dr. Seder received his BA from Johns Hopkins University and MD degree from the Tufts University. He completed his internal medicine residency at New York Hospital/Cornell Medical Center. In 1989, he came to the NIH and received four years of postdoctoral training in the Laboratory of Immunology. Since then, he has remained as a senior investigator at the NIH in the Laboratory of Clinical Investigation and for the past 12 years at the Vaccine Research Center. His work has been published in over 100 publications in prestigious journals including Science, Nature Medicine, Proceedings of the National Academy of Sciences USA, Journal of Experimental Medicine, Journal of Clinical Investigation, and The New England Journal of Medicine. He is an elected Fellow of ASCI and AAP.
Claire-Anne Siegrist, MD, PD Dr. Siegrist is Professor of Vaccinology and Pediatrics at the University of Geneva, Switzerland, Director of the Center of Vaccinology of the University Hospitals of Geneva, Director of the Center for Vaccinology and the Pediatric Department of the University of
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Geneva, and Head of the WHO Collaborating Center for Vaccine Immunology. After receiving her training and board certification in pediatrics and infectious disease, Dr. Siegrist obtained an Advanced Immunology Diploma from AixMarseille II University, France, and in 1994, initiated a new research group on Vaccinology and Neonatal Immunology, recognized since 1996 as a WHO Collaborating Center. With her thesis on Vaccination in Early Life, she obtained her PD accreditation in 1998. She was nominated as Professor of Vaccinology at the University of Geneva in 1999. In 2005, she received the Bill Marshall Award from the European Society for Pediatric Infectious Diseases. Professor Siegrist has been the President of the Swiss Advisory Committee for Immunizations (CFV/ EKIF) since 2004. She was nominated at the UK Joint Committee for Vaccination and Immunization (JCVI) in 2008 and at the WHO Strategic Advisory Group of Experts (SAGE) in 2010. She has contributed to a large number of original scientific publications in the field of vaccine immunology, studying in particular the mechanisms that shape early life vaccine responses and how certain vulnerable populations respond to immunization. The quality and the objectivity of her engagement for the promotion of evidence-based vaccinology is recognized and appreciated worldwide.
J. Erin Staples, MD, PhD Dr. J. Erin Staples is a medical epidemiologist at the Centers for Disease Control and Prevention (CDC) in the Arboviral Diseases Branch, Division of Vector-Borne Diseases located in Fort Collins, CO. In this role, she serves as a subject matter expert and consultant for various national and international committees in the field of arboviral diseases and related vaccines. She also conducts outbreak investigations for both national and international arboviral diseases, and designs and implements research studies addressing gaps or key questions related to arboviral epidemiology, vaccines, or interpretation of laboratory results.
on Vaccine Research INVITED SPEAKER BIOGRAPHIES Her particular areas of research focus on yellow fever, chikungunya, West Nile viruses, blood and transplant associated arboviral infections, and tick-borne arboviral diseases. She oversees the surveillance of domestic arboviral diseases and supervises Preventive Medicine Residents, Epidemic Intelligence Service Officers, and Epidemiologic Training Students who are training in epidemiology and public health. Dr. Staples has both a doctoral degree in microbiology and immunology and a medical degree, having trained as a pediatric infectious disease physician at Duke University Medical Center. Her past work experiences include bacterial zoonotic diseases at CDC, vaccine development in industry, and clinical work in pediatrics and pediatric infectious diseases. She has published on a variety of scientific subjects.
and improved delivery. These vaccines display improved immune potency in NHP and in humans. His laboratory has published 330+ peer reviewed scientific research publications or reviews and 7 books or special volumes on these topics. Dr. Weiner is an avid supporter of scientific education, and graduate and post graduate student training. He has served and continues to serve on many advisory boards and as a consultant to Academic organizations as well as to industry. In the last few years this service includes working with many diverse and important organizations such as; NIH, FDA, NIBSC, WHO, the Gates Foundation, Pfizer, Inovio, BMS, Medimmune, Novartis, Merck, and J & J, among others. Dr. Weiner was elected a fellow of the American Academy for the Advancement of Science in 2011.
David B. Weiner, PhD Dr. Weiner is Professor of Pathology and Laboratory Medicine, and Chair of the Gene Therapy and Vaccines Graduate Program, at the University of Pennsylvania. He has worked extensively in the areas of molecular immunology, viral pathogenesis, focusing on the development of gene-based vaccines, immune therapies, and molecular interventions for human diseases. Dr. Weiner’s laboratory is one of the founding groups of the field of DNA vaccines. Importantly and atypically, his laboratory and their collaborators were the first to move DNA vaccines to human clinical studies and establish their initial safety and immunogenicity, thus opening up this area for clinical development. His group was among the first to report that these original approaches induced low immunity in humans and moved research in this area back to the bench. His lab has been instrumental in the recent resurgence of interest in the DNA vaccine field due to developing second generation synthetic DNA vaccines
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The Fifteenth Annual Conference
ABSTRACTS OF INVITED PRESENTATIONS
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on Vaccine Research ABSTRACTS OF INVITED PRESENTATIONS
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Keynote Address: Vaccine Discovery – A Varied Process Stanley A. Plotkin, MD University of Pennsylvania Vaxconsult LLC Doylestown, PA
Objective: Understand how vaccines are actually developed by examining past and future strategies. Abstract: Over the last 220 years, vaccines have been discovered both by accident and by careful planning. Although it is sometimes said that vaccines were developed empirically, generally the idea was to mimic the mechanism of immunity after natural infection. Inactivation, extraction, purification, and attenuation have generally been the methods for inducing antibody and occasionally cellular immune responses. Now we face situations where the mechanism of natural protection is not obvious. Pathogens like HIV, cytomegalovirus, staphylococcus, and malaria are examples of this problem. Therefore, new approaches will be necessary, although trial and error will continue to be a major way forward. It is likely that single antigens will not be sufficient for optimal protection and indeed that more than one immune response will have to be induced. References: 1. Plotkin SA. Vaccines: the fourth century. Clin Vaccine Immunol. 2009;16(12):1709-19. 2. Plotkin SA, Plotkin SL. The development of vaccines: how the past led to the future. Nat Rev Microbiol. 2011;9(12):889-93.
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Advances in Influenza Virus Vaccine Discovery and Immunology Daniel R. Perez, PhD Department of Veterinary Medicine, University of Maryland, College Park College Park, MD
Objectives: Discuss the recent advances in influenza vaccine discovery, studies towards a universal, long-lasting vaccine, and implementation of live influenza vaccines with universal backbones as a vaccine vector for use in humans and agriculture. Abstract: Influenza is an acute viral respiratory disease that affects all age groups. Influenza epidemics continue to be a major disease burden in humans; approximately 5-15% of the population is infected on an annual basis. Severe influenza disease is estimated to affect 3 - 5 million people worldwide, and is associated with 250,000 - 500,000 deaths annually. Despite efforts to curtail the emergence of novel pandemic influenza strains, an influenza virus of swine origin was responsible for an influenza pandemic in 2009. Vaccination provides an effective means for control of influenza and it is considered the first line of defense against the virus. Human influenza vaccines are produced as either split virion inactivated (killed vaccines, KV), or live attenuated vaccines (LAIV). These vaccines are reformulated every year due to the virus’ ability to undergo antigenic drift and escape the immunological pressure developed against previous strains. Both types of vaccines are largely produced in fertilized chicken eggs. Since most human influenza strains carry mutations that may limit their growth in eggs or tissue culture, vaccine strains are produced from reassortants that generally carry the surface gene segments from the vaccine candidate and other segments from a high growth donor virus. Reverse genetics has certainly improved the ability to generate such high growth reassortants; however, growing influenza viruses in eggs or tissue culture may result in adaptive changes on the surface genes that lead to poor antigenic matching. LAIV
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The Fifteenth Annual Conference ABSTRACTS OF INVITED PRESENTATIONS have an advantage over inactivated vaccines since they could produce a broader response by estimulating both the humoral and the T-cell arms of the immune system. The 2009 pandemic H1N1 virus (pH1N1), however, highlighted the fact that these traditional vaccine production systems are too slow to significantly ameliorate and/or alter the impact of an influenza pandemic. Alternative influenza vaccine strategies have been investigated including recombinant plasmid DNA, different recombinant viruses, and virus-like particles (VLPs). Current efforts towards universal influenza vaccines, use of the influenza as a vaccine vector against other diseases and the potential use of modified live attenuated influenza vaccines in agriculture will be discussed. References: 1. Pena L, Vincent AL, Ye J, et al. Modifications in the polymerase genes of a swine-like triple reassortant influenza virus to generate live attenuated vaccines against 2009 pandemic H1N1 viruses. J Virol. 2010;85(1):456-69. 2. Solórzano A, Ye J, Pérez DR. Alternative live-attenuated influenza vaccines based on modifications in the polymerase genes protect against epidemic and pandemic flu. J Virol. 2010;84(9):4587-96. 3. Hickman D, Hossain MJ, Song H, Araya Y, Solórzano A, Pérez DR. An avian live attenuated master backbone for potential use in epidemic and pandemic influenza vaccines. J Gen Virol. 2008;89(Pt 11):2682-90.
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Vaccines for Malaria Elimination: Progress and Challenges Ahead Christian F. Ockenhouse, MD, PhD Walter Reed Army Institute of Research Silver Spring, MD
Objectives: Discuss the most recent advances in malaria vaccine development as related to technical hurdles, vaccine design, clinical testing, and efficacy testing for down selection of promising lead candidates for laterstage phase three testing. Describe the most recent phase three study in sub-Saharan Africa of the malaria vaccine RTS,S, and the challenges ahead. Summarize the practical, logistical, and financial challenges faced by the international community as it prepares for the implementation of a licensed malaria vaccine. Abstract: Malaria remains a serious threat to the global health of millions of infants, children, and adult travelers. At least 750,000 children die annually in sub-Saharan Africa from Plasmodium falciparum malaria with hundreds of millions of cases world-wide of clinically-significant disease from both P. falciparum and P. vivax malaria. Due to the enhanced interest in broadening malaria control initiatives to eventual elimination and eradication, campaigns will require the implementation of an effective malaria vaccine against both P. falciparum and P. vivax malaria that prevents infection, prevents disease, and blocks transmission. This presentation will provide an update on the status of the most promising and advanced malaria vaccine candidate, RTS,S, currently in phase three trials in Africa, and will also address the challenges ahead for second generation molecular-based subunit and whole parasite vaccines that target the parasite to prevention infection to both the host (man) and its vector (mosquito). Finally, some of the logistical, financial, and strategic challenges that lie ahead in implementation of a licensed malaria vaccine will be highlighted. References: 1. Regules JA, Cummings JF, Ockenhouse CF. The RTS,S vaccine candidate for malaria. Expert Rev Vaccines. 2011;10(5):589-99. 2. malERA Consultative Group on Vaccines. A research agenda for malaria eradication: vaccines. PLoS Med. 2011;8(1):e1000398. 54
on Vaccine Research ABSTRACTS OF INVITED PRESENTATIONS
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Novel Engineering of Synthetic HIV-1 Consensus Envelop Second Generation DNA Vaccines David B. Weiner, PhD University of Pennsylvania Philadelphia, PA
Objective: Discuss technological improvements in the DNA vaccine platform improving its ability to drive relevant magnitude and focused immune responses. Abstract: DNA vaccines are an important and novel vaccine technology, which has specific conceptual advantages over traditional vaccine modalities. However, in humans the immune potency of this approach has been weak. We have focused on improving the immune potency of this vaccine platform through a combination of technologies including plasmid optimization and adjuvant technology, combined with enhanced electroporation (EP) delivery. Together these approaches have resulted in dramatic improvement of the immune potency of the platform in large primates and humans. We have now turned our focus to improving the immune responses induced against viral membrane antigens including HIV envelopes. We will present data in animal models that illuminate specific features of these improved DNA vaccine and benchmark their development against other important technologies. These studies have implications for the expansion of this platform against difficult pathogens including HIV. References: 1. Belisle SE, Yin J, Shedlock DJ, et al. Long-term programming of antigen-specific immunity from gene expression signatures in the PBMC of rhesus macaques immunized with an SIV DNA vaccine. PLoS One. 2011;6(6):e19681. 2. Sardesai NY, Weiner DB. Electroporation delivery of DNA vaccines: prospects for success. Curr Opin Immunol. 2011;23(3):421-9. 3. Hirao LA, Draghia-Akli R, Prigge JT, et al. Multivalent smallpox DNA vaccine delivered by intradermal electroporation drives protective immunity in nonhuman primates against lethal monkeypox challenge. J Infect Dis. 2011;203(1):95-102. 4. Morrow MP, Weiner DB. DNA drugs come of age. Sci Am. 2010;303(1):48-53. 5. Hirao LA, Wu L, Satishchandran A, et al. Comparative analysis of immune responses induced by vaccination with SIV antigens by recombinant Ad5 vector or plasmid DNA in rhesus macaques. Mol Ther. 2010;18(8):1568-76. 6. Morrow MP, Pankhong P, Laddy DJ, et al. Comparative ability of IL-12 and IL-28B to regulate Treg populations and enhance adaptive cellular immunity. Blood. 2009;113(23):5868-77.
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Progress on Universal Influenza Vaccines: Protecting against Unexpected Outbreaks and Pandemics Suzanne L. Epstein, PhD US Food and Drug Administration Rockville, MD
Objectives: Discuss new approaches to influenza vaccination not dependent upon prediction of circulating virus strains and production of matched vaccines. Describe characteristics of the antibody and T cell immunity involved, and types of vaccine candidates with promise for broad cross-protection against influenza infection regardless of subtype.
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The Fifteenth Annual Conference ABSTRACTS OF INVITED PRESENTATIONS Abstract: Influenza virus infection continues to cause considerable morbidity and mortality worldwide. Frequent changes in the virus make control by vaccination difficult, since current vaccines are strain-matched. If an unexpected drift variant or a pandemic strain emerges, vaccine availability is delayed by months, with serious illness and deaths occurring in the meanwhile. In animal models, immunity to less variable influenza virus antigens can protect even against strains of highly divergent subtypes. We have studied this type of broad cross-protection using conserved influenza antigens nucleoprotein (NP)1 and matrix 2 (M2)2 expressed by DNA vaccines, recombinant adenoviruse type 5 (rAd5) expressing influenza antigens, cold-adapted influenza viruses, and adeno-associated virus (AAV).3 NP+M2 Ad5-based vaccines are particularly effective either for boosting after DNA priming4 or as single-dose vaccines.5 They induce particularly effective, long-lasting immunity that protects mice against challenge with virulent viruses of H1N1, H3N2, and H5N1 subtypes. In mice, intranasal (i.n.) rAd vaccination is more effective than intramuscular (i.m.), for protection against virus challenge from weeks to many months later. Compared to i.m., vaccination i.n. results in better survival, reduced morbidity, more IgA, greater, more activated lung T cell responses, and greater reduction in lung viral replication. In ferrets, primeboost vaccination to NP+M2 with either i.n. or i.m. boosting protected against H5N1, with reduction in nasal viral titers that may be relevant to transmission.5 The hemagglutinin stem provides another conserved target for vaccination, and is under study by others. Broadly protective vaccines could be used off the shelf as a first line of defense during a rapidly spreading outbreak, when matched vaccines are not yet available, and perhaps someday in advance of an outbreak or pandemic. References: 1. Epstein SL, Kong WP, Misplon JA, et al. Protection against multiple influenza A subtypes by vaccination with highly conserved nucleoprotein. Vaccine. 2005;23(46-47):5404-10. 2. Tompkins SM, Zhao ZS, Lo C-Y, et al. Matrix protein 2 vaccination and protection against influenza viruses, including subtype H5N1. Emerg Infect Dis. 2007;13(3):426-35. 3. Quinn K, Quirion MR, Lo CY, Misplon JA, Epstein SL, Chiorini JA. Intranasal administration of adenoassociated virus type 12 (AAV12) leads to transduction of the nasal epithelia and can initiate transgenespecific immune response. Mol Ther. 201119(11):1990-8. 4. Price GE, Soboleski MR, Lo CY, et al. Vaccination focusing immunity on conserved antigens protects mice and ferrets against virulent H1N1 and H5N1 influenza A viruses. Vaccine. 2009;27(47):6512-21. 5. Price GE, Soboleski MR, Lo CY, et al. Single-dose mucosal immunization with a candidate universal influenza vaccine provides rapid protection from virulent H5N1, H3N2 and H1N1 viruses. PLoS ONE. 2010;5(10):e13162.
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An Introduction to Rotavirus Vaccines and Remaining Challenges Ahead Roger I. Glass, MD, PhD National Institutes of Health Bethesda, MD
Objectives: Understand the impact of rotavirus vaccines in the US and in low-resource settings. Articulate the role of physicians as advocates for rotavirus vaccine in improving the health of patients and populations in their communities around the world. Discuss remaining challenges for the use of rotavirus vaccine in low-income countries.
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on Vaccine Research ABSTRACTS OF INVITED PRESENTATIONS Abstract: Since 2006, rotavirus vaccines have been licensed in more than 100 countries, introduced into the routine childhood immunization programs of more than 30 countries, and recommended by WHO for the immunization of all children worldwide. To date, in those countries where the impact of the vaccine has been assessed, the results have been impressive. The United States has witnessed a decrease by nearly half of hospitalizations and emergency room visits of children < 5 years with severe diarrhea and a 3-5% decline in total hospitalizations of children for all causes. An unanticipated benefit of the vaccine program has been the demonstration of herd protection evidenced as a reduction in winter diarrhea hospitalizations among older children (>5 years) and adults who were never thought to be at great risk of rotavirus diarrhea. This observation has added an additional 15-20% to the economic benefit of the vaccine and indicates young children may serve as a potent reservoir for rotavirus in the community. In Mexico and Brazil, the vaccine has specifically been associated with substantial decrease in seasonal diarrheal mortality as well. A key target group for rotavirus vaccines remains children in low income countries where 85% of the ~450,000 deaths from rotavirus occur. To date, four low income countries have introduced rotavirus vaccines for routine use and another 15 are scheduled to begin introduction with support from GAVI. The recent refinancing of GAVI, and a substantial lowering of vaccine price offered to UNICEF by the manufacturers, have given new hope that this effort can now proceed rapidly. Furthermore, within five years, a number of new rotavirus vaccines from emerging manufacturers could be introduced that might increase global supply and further lower vaccine cost. As these vaccines are introduced into low income countries, evaluation of their impact will be critical; effectiveness of the program could be substantially greater than anticipated if herd protection is at play, or substantially less if these live oral vaccines perform less well in these settings or if coverage is low or delayed, so that vaccine fails to reach the target populations. After many years of anticipation, we have finally started down the road to control rotavirus diarrhea with the use of vaccine. While there are still many hurdles ahead until we accomplish the goal of reducing mortality from diarrhea among children in the developing world and reducing hospitalizations, clinic visits, and illness among all children, rich or poor, the process has begun. References: 1. Patel M, Shane A, Parashar U, et al. Oral Rotavirus Vaccines: How Well Will They Work Where They Are Needed Most? The Journal of Infectious Diseases. 2009; 200:S39-48. 2. Glass R. New hope for defeating rotavirus. Scientific American. 2006; April: 47-55. 3. Anthony E, Nelson S, Glass R. Rotavirus: realizing the potential of a promising vaccine. The Lancet. August 21, 2010: Volume 376.
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Rotavirus Vaccines: A Review of Vaccine Trial Results Kathleen M. Neuzil, MD, MPH PATH Seattle, WA
Objectives: Describe global rotavirus vaccine use and discuss strategies to maximize the impact of rotavirus vaccines in low-resource settings. Abstract: For developing countries in Africa and Asia, where the preponderance of rotavirus-related deaths occur, the lack of an evidence base for the efficacy of oral rotavirus vaccines delayed policy decisions on their use. Fortunately, introduction of rotavirus vaccines into those countries is now underway, catalyzed by data from
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The Fifteenth Annual Conference ABSTRACTS OF INVITED PRESENTATIONS three large randomized, controlled efficacy trials of the currently licensed rotavirus vaccines. Data from those trials and post-licensure experiences from early-introducer countries informed a WHO recommendation for global use of the vaccine, and the decision by GAVI to support the vaccine. In 2011, the first GAVI-eligible country in Sudan, Africa, introduced the vaccine. The immunogenicity of the vaccines and the efficacy estimates for low-resource populations reported in the clinical trials were lower than what had been reported in high resource settings. Understanding the design of the trials and the plethora of results is a prerequisite to informing efforts to improve the efficacy of these vaccines in such settings. Additional studies are underway to determine how these vaccines should best be used in various settings throughout the world. Even with the moderate efficacy observed with the current rotavirus vaccines, the absolute disease reductions are anticipated to be substantial in low-resource countries due to the tremendous disease burden. This session will present new data from trials and discuss some of the reasons behind the lower efficacy estimates. References: 1. Madhi SA, Cunliffe NA, Steele D, et al. Effect of human rotavirus vaccine on severe diarrhea in African infants. N Engl J Med. 2010;362(4):289-98. 2. Zaman K, Dang DA, Victor JC, et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;376(9741):615-23. 3. Armah GE, Sow SO, Breiman RF, et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;376(9741):606-14.
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Post-Licensure Surveillance: The Impact of Vaccines and Concerns About Intussusception Umesh Parashar, MBBS Centers for Disease Control and Prevention Atlanta, GA
Objective: Discuss the post-licensure effectiveness and safety data from countries that have adopted routine childhood vaccination against rotavirus. Abstract: Since 2006, two new vaccines have been licensed to prevent rotavirus, the cause of 20%-50% of severe acute gastroenteritis in young children worldwide. These vaccines have been implemented in national immunization programs in about 30 high- to middle-income countries, including the United States, and vaccine use has led to substantial declines in diarrhea-related healthcare visits. In addition to reductions in diarrhea burden in vaccinated children, declines have been observed in older, unvaccinated age groups in many settings, suggesting indirect benefits (i.e., herd immunity) from vaccination. A low level risk of intussusception has been associated with rotavirus vaccines in some countries but not in others. Furthermore, given that the observed benefits of rotavirus vaccination greatly exceed the risks, international policy and regulatory bodies have continued to support global recommendations for use of rotavirus vaccines. References: 1. Cortes JE, Curns AT, Tate JE, et al. Rotavirus vaccine and healthcare utilization for diarrhea in US children. N Engl J Med. 2011;365(12):1108-17. 58
on Vaccine Research ABSTRACTS OF INVITED PRESENTATIONS 2. Payne DC, Staat MA, Edwards KM, et al. Direct and indirect effects of rotavirus vaccination upon childhood hospitalizations in 3 US counties, 2006-2009. Clin Infect Dis. 2011;53(3):245-53. 3. Staat MA, Payne DC, Donauer S, et al. Effectiveness of pentavalent rotavirus vaccine against severe disease. Pediatrics. 2011;128(2):e267-e75. 4. Lopman BA, Curns AT, Yen C, Parashar UD. Infant rotavirus vaccination may provide indirect protection to older children and adults in the United States. J Infect Dis. 2011;204(7):980-6. 5. Richardson V, Hernandez-Pichardo J, Quintanar-Solares M, et al. Effect of rotavirus vaccination on death from childhood diarrhea in Mexico. N Engl J Med. 2010;362(4):299-305.
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Introduction of an Affordable Group A Meningococcal Conjugate Vaccine in the African Meningitis Belt F. Marc LaForce, MD PATH Washington, DC
Objectives: Relate the epidemiology of epidemic meningococcal meningitis in Sub-Saharan Africa. Explain the importance of herd immunity with conjugate polysaccharide vaccines. Understand immunologic responses after polysaccharide and conjugate vaccination. Abstract: Epidemic meningitis due to Group A Neisseria meningitidis (NmA) continues to be an important public health problem in Sub-Saharan Africa. Over the last decade the Meningitis Vaccine Project (MVP), a Gates Foundation funded partnership between PATH and WHO, has developed, tested, licensed, and introduced a new and affordable ($US < 0.50 per dose) Group A meningococcal conjugate vaccine (MenAfriVacTM) manufactured by the Serum Institute of India. The vaccine was prequalified by WHO in June 2010 and extensive pharmacovigilance studies in Burkina Faso, Mali, and Niger did not reveal any unexpected safety problems. Country-wide vaccination of 10.6 million 1-29 year old Burkinabes were performed between December 6-16, 2010. The vaccine was well received (>95% coverage) and in 2011 only a single case of meningitis due to NmA was identified in a non-vaccinee, despite intense laboratory based surveillance. Mali and Niger chose to immunize their 1-29 year old population over two years (2010-2011). The December 2011 campaigns included northern Cameroon, five states in northern Nigeria and two million doses in southwestern Chad. As of December 31, 2011 over 56 million Africans have received a dose of MenAfriVacTM. This is the first vaccine to be designed specifically for Africa that received WHO prequalification. Early impact data are consistent with broad herd immunity against NmA. Rollout of MenAfriVacTM will continue over the next five years and over 300 million Africans are expected to be immunized. The MVP experience is a successful example of how a needed vaccine was efficiently developed through a public/private partnership using modest amounts of “push funding.” References: 1. LaForce FM, Ravenscroft N, Djingarey M, Viviani S: Epidemic meningitis due to Group A Neisseria meningitidis in the African meningitis belt: a persistent problem with an imminent solution. Vaccine. 2009;27(Suppl 2):B13-19. 2. Sow SO, Okoko BJ, Diallo A, et al. Immunogenicity and safety of a meningococcal A conjugate vaccine in Africans. N Engl J Med. 2011;364(24):2293-304. 3. LaForce FM, Okwo-Bele JM: Eliminating epidemic Group A meningococcal meningitis in Africa through a new vaccine. Health Affairs (Millwood). 2011;30(6):1049-57.
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The Challenge of Typhoid Andrew J. Pollard, PhD University of Oxford Oxford, United Kingdom
Objectives: Discuss the clinical burden of enteric fever, diagnostic difficulties, and approaches to vaccine prevention. Understand the development and utility of a human challenge model of typhoid infection to accelerate the development of typhoid vaccines and the pathophysiology and immunobiology of enteric fever. Abstract: Up to 200,000 deaths are caused every year by infection with Salmonella enterica serovar Typhi, transmitted exclusively among human populations through poor water and sanitation. The true incidence is difficult to estimate as diagnostic tests underestimate the burden as a result of limited availability and poor sensitivity. Provision of clean water and sanitation will control enteric fever and other enteric pathogens and must be pursued, but requires vast investment in infrastructure in affected regions and cannot provide a rapid solution to the problem. Intervention with vaccines against enteric fever could interrupt transmission and lead to control in a short-time frame. In the 1960’s a human challenge model of typhoid infection was developed at the University of Maryland to accelerate the development of typhoid vaccines and led to the further development of the now widely available licensed live oral vaccine, Ty21a. Despite this pioneering work, clinical development of novel vaccines remains hampered by the limited understanding of mechanisms of protection. We developed a human typhoid challenge model in Oxford, UK, to provide insight into the pathogenesis of Salmonella Typhi infection, to identify correlates of protection and biomarkers that might be used in diagnosis and to investigate the efficacy of novel vaccines. Volunteers were challenged with 1,000 to 10,000 CFUs of S. Typhi in a bicarbonate buffer and monitored for two weeks before treatment, unless they developed clinically or microbiologically defined enteric fever, when they were treated immediately. An attack rate of 65% was achieved with the higher dose and was associated with a shorter incubation period than the lower dose, but both doses had a typical pattern of clinical and laboratory findings. The human typhoid challenge model will now be used to investigate the potential of novel vaccines to prevent typhoid fever and to investigate the immunobiology of any protective mechanisms. References: 1. Crump JA, Luby, SP, Mintz ED. The global burden of typhoid fever. Bull World Health Organ. 2004;82(5):346-53. 2. Baker S, Favorov M, Dougan G. Searching for the elusive typhoid diagnostic. BMC Infect Dis. 2010;10:45. 3. Bhutta ZA. Current concepts in the diagnosis and treatment of typhoid fever. BMJ. 2006;333(7558):7882. 4. Hornick RB, Greisman SE, Woodward TE, DuPont HL, Dawkins AT, Snyder MJ. Typhoid fever: pathogenesis and immunologic control. 2. N Engl J Med. 1970;283(14):739-46. 5. Thompson LJ, Dunstan SJ, Dolecek C, et al. Transcriptional response in the peripheral blood of patients infected with Salmonella enterica serovar Typhi. Proc Natl Acad Sci U S A. 2009;106(52):22433-8. 6. Pulickal AS, Gautam S, Clutterbuck EA, et al. Kinetics of the natural, humoral immune response to Salmonella typhi in Kathmandu, Nepal. Clin Vaccine Immunol. 2009;16(10):1413-9. 7. Holt KE, Baker S, Dongol S, et al. High-throughput bacterial SNP typing identifies distinct clusters of Salmonella typhi causing typhoid in Nepalese children. BMC Infect Dis. 2010;10:144.
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Human Vaccines against Enterotoxigenic Escherichia coli Diarrhea: Old Themes and New Developments CAPT Stephen J. Savarino, MD, MPH Naval Medical Research Institute Bethesda, MD
Objectives: Understand the main populations at risk for diarrhea caused by enterotoxigenic Escherichia coli (ETEC) to inform thinking on policy guidelines and implementation of licensed ETEC vaccines. Review the general mechanisms of enterotoxigenic Escherichia coli (ETEC) disease pathogenesis to inform critical evaluation of current vaccine development efforts. Recognize the bacterial components implicated as protective antigens for studies of oral passive administration of enterotoxigenic Escherichia coli (ETEC) hyperimmune bovine colostral antibodies to volunteers. Abstract: Enterotoxigenic Escherichia coli (ETEC) is a common cause of travelers’ diarrhea and an important cause of diarrhea morbidity and mortality in young children in resource-limited countries. Key pathogenic factors include fimbrial colonization factors that mediate small intestinal adhesion and heat-stable (ST) and heat-labile (LT) enterotoxins that promote fluid and electrolyte secretion. During the 1980s and 1990s, several approaches to making an ETEC vaccine were explored without a commercial success. These included toxoids, purified fimbriae, live attenuated ETEC, and whole-cell killed ETEC vaccines, each given by oral delivery. Since 2000, similar vaccine approaches have been revived with the aid of improved knowledge on structure and function, recombinant DNA technology, and structural biology. Other routes of delivery have also been examined for their potential in generating protective mucosal immune responses. An LT vaccine given by the transcutaneous route was advanced into field trials and shown not to confer sufficiently broad protection to be useful, although protection against LT-producing ETEC was observed. Genetically attenuated ST peptides genetically fused to carrier proteins are in preclinical development. New generations of oral live, attenuated and killed whole-cell ETEC vaccines are in clinical development with work ongoing to define suitable adjuvants for both. Advances in our knowledge of ETEC fimbrial biogenesis, structure and function have served as the basis for development of a refined adhesin-based ETEC vaccine. Using CFA/I fimbriae as the prototype, we have shown that intestinal adherence can be ascribed to CfaE, a minor protein that is localized to the fimbrial tip. Favorable findings from studies of the biophysicochemical, functional and immunological properties of this and other conserved ETEC fimbrial adhesins has served as the basis for advancing a prototype ETEC adhesin vaccine into Phase 1 clinical evaluation. With several improved ETEC vaccines now in preclinical or clinical evaluation, perhaps one or more will be licensed and added to our preventive armamentarium in the not too distant future. References: 1. Sack, DA, Shimko J, Torres O, et al. Randomised, double-blind, safety and efficacy of a killed oral vaccine for enterotoxigenic E. coli diarrhoea of travellers to Guatemala and Mexico. Vaccine 2007;25:4392-400. 2. Poole ST, McVeigh AL, Anantha RP, et al. Donor strand complementation governs intersubunit interaction of fimbriae of the alternate chaperone pathway. Mol Microbiol 2007;63:1372-84. 3. Frech SA, DuPont HL, Bourgeois AL, McKenzie R, et al. Use of a patch containing heat-labile toxin from Escherichia coli against travellers’ diarrhoea: a phase II, randomised, double-blind, placebo-controlled field trial. Lancet 2008;371:2019-25. 4. Svennerholm AM, From cholera to enterotoxigenic Escherichia coli (ETEC) vaccine development, Indian J Med Res 2011;133:188-194.
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The Fifteenth Annual Conference ABSTRACTS OF INVITED PRESENTATIONS 5. The Case for Investment in Enterotoxigenic Escherichia coli Vaccines, March 2011, Program for Appropriate Technology in Health (PATH) and BIO Ventures for Global Health (BVGH), www.path.org or www.bvgh.org.
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Role for Cholera Vaccines as an Adjunct Control Measure During Cholera Outbreaks in Complex Emergencies Claire-Lise Chaignat, MD, MPH University of Geneva World Health Organization Geneva, Switzerland
Objectives: Review the key features of cholera at the global level. Understand the importance of identifying cholera hotspots based on risk assessment. Identify the basics of a comprehensive coordinated approach for cholera control. Recognize the role cholera vaccines might play as an adjunct measure to routinely recommended cholera prevention and control measures. Abstract: Cholera is a well-known disease which occurs in explosive outbreaks. Often it occurs as a surprise to countries which are not prepared to detect first cases timely and to respond efficiently, resulting in high mortality and human suffering. Recently, cholera has been on the rise with massive outbreaks being reported from several countries which had been free of the disease for years. Cholera remains one of the world’s most underreported diseases, affecting the most marginalized population groups living in precarious situations, such as shanty towns or complex emergency settings. As a response to the increasing trends of cholera incidence over recent years, the World Health Assembly adopted Resolution 64.15 on Cholera: Mechanism for Prevention and Control, which calls for an integrated coordinated and comprehensive approach for cholera control. While improved access to safe drinking water and proper sanitation along with a strong mobilization of affected communities are the basis for any cholera control program, the role of cholera vaccines as an adjunct measure has recently been recognized. Even though oral cholera vaccines have been available for some years, introduction remains a challenge in view of the two dose regimen, as well as the limited production capacities and availability at global level. The need for new and easy to administer vaccines, particularly single dose regimen vaccines is recognized, as well as the availability of a vaccine stockpile which could facilitate equitable access to the ones most. References: 1. Cholera 2010. Weekly Epidemiological Record 2011, 86(31):325-340; http://www.who.int/cholera/ statistics/en/index.html 2. Cholera vaccines: WHO position paper. Weekly Epidemiological Record, 2010, 85:117–128; http://www. who.int/wer
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The Effectiveness of Vaccines at Reducing Salmonella Contamination of Poultry John J. Maurer, PhD Center for Food Safety University of Georgia College of Veterinary Medicine Athens, GA
Objectives: Discuss the poultry production system in the US and how Salmonella is transmitted within this food production system. Understand the impact of vaccination on reducing Salmonella contamination of eggs and poultry meat. Abstract: Salmonella is one of the leading causes of foodborne illnesses in the US; accounting for one million cases each year6. Poultry has been implicated in 17% of foodborne outbreaks in the US1. The current regulatory focus of the USDA is in the meat processing plant, where most interventions for reducing carcass contamination with pathogens (i.e. chlorination) are implemented. However, further reduction of pathogen contamination and subsequent reduction of human illness will require reduction of contamination in birds entering the processing plant. An “on-farm” approach to food safety requires knowledge of the food production system and the epidemiology of the pathogen within this system. Poultry production in the US is completely integrated where a single company controls all aspects of poultry production. Within this system, farmers are contracted to raise chickens either as breeding stock or for consumption. The company provides the contract farmers with the birds, feed, and veterinary care. Salmonella can enter at any point within this system. Where does one introduce an intervention like vaccination within the poultry production pyramid that would be most effective at reducing Salmonella transmission, and ultimately egg and meat contamination? In poultry, Salmonella can be transmitted vertically from breeder stock to progeny meat birds4,5. Egg transmission is not limited to Salmonella Enteritidis but has been observed for other serovars including S. typhimurium, S. heidelberg, and S. kentucky. Therefore, vaccination of breeder flocks against circulating Salmonella serovars should reduce egg transmission and subsequently Salmonella contamination of chicken carcasses. We examined the impact of vaccination on vertical transmission of Salmonella and chicken carcass contamination for two commercial poultry companies, with one serving as the unvaccinated control. In a commercial setting, administration of combination live and killed Salmonella vaccines to juvenile breeder flocks reduced Salmonella colonization, subsequent egg transmission, and carcass contamination compared to the unvaccinated controls. While vaccination reduced carcass contamination with Salmonella, it did not change Salmonella serovar distribution during the 18 months of the study. In examining differences between the two poultry companies with regards to production and management practices, the only significant factor that correlated with Salmonella prevalence was vaccination3. In a subsequent study, we focused on the company serving as our unvaccinated control and convinced them to implement a vaccine program of their breeders. In this study we were able to have, within the one company, vaccinated and unvaccinated breeders to study and their progeny birds to process. This time juvenile breeder flocks were only given a killed vaccine containing the major Salmonella serovars specifically circulating within this companies poultry farms. We observed a similar reduction in Salmonella prevalence in breeder and progeny flocks, and decreased pathogen load on Salmonella positive farms, which suggests vaccination was reducing fecal shedding of the pathogen. Breeder birds mounted a strong humoral response to Salmonella serovars used in the vaccine formulation2. Similarly, vaccination of commercial table egg-laying hens against S. Enteritidis is effective at controlling egg contamination with this Salmonella serovar7. Vaccination appears to be an effective, on-farm intervention for reducing Salmonella
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The Fifteenth Annual Conference ABSTRACTS OF INVITED PRESENTATIONS contamination of eggs and poultry meat. However, the challenge of any vaccination program is due diligence in monitoring for myriad of Salmonella serovars circulating in nature. References: 1. Centers for Disease Control and Prevention (CDC). Surveillance for foodborne disease outbreaks - United States, 2007. MMWR Morb Mortal Wkly Rep. 2010; 59(31):973-9. 2. Berghaus RD, Thayer SG, Maurer JJ, Hofacre CL. Effect of vaccinating breeder chickens with a killed Salmonella vaccine on Salmonella prevalences and loads in breeder and broiler chicken flocks. J Food Prot. 2011;74(5):727-34. 3. Dórea FC, Cole DJ, Hofacre C, et al. Effect of Salmonella vaccination of breeder chickens on contamination of broiler chicken carcasses in integrated poultry operations. Appl Environ Microbiol. 2010;76(23):78205. 4. Liljebjelke KA, Hofacre CL, Liu T, et al. Vertical and horizontal transmission of salmonella within integrated broiler production system. Foodborne Pathog Dis. 2005;2(1):90-102. 5. Sander J, Hudson CR, Dufour-Zavala L, et al. Dynamics of Salmonella contamination in a commercial quail operation. Avian Dis. 2001;45(4):1044-9. 6. Scallan E, Hoekstra RM, Angulo FJ, et al. Foodborne illness acquired in the United States--major pathogens. Emerg Infect Dis. 2011;17(1):7-15. 7. Toyota-Hanatani Y, Ekawa T, Ohta H, et al. Public health assessment of Salmonella enterica serovar enteritidis inactivated-vaccine treatment in layer flocks. Appl Environ Microbiol 2009;75(4):1005-10.
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New Technologies in Vaccine Design Roy Curtiss III, PhD Biodesign Institute Arizona State University Tempe, AZ
Objectives: Discuss strategies for attenuation of and antigen delivery from recombinant bacterial vaccines to optimize immunogenicity and decrease dosages. Review the application of technologies to develop vaccines against infectious diseases of agriculturally important animals, and strategies for attenuation of and antigen delivery from recombinant bacterial vaccines to optimize immunogenicity and decrease dosages. Abstract: Live attenuated bacterial vaccines and their recombinant derivatives that can be economically produced and administered by spray or orally in feed or drinking water are superior to killed or subunit vaccines to control infectious diseases in agriculturally important animals. We have focused our efforts in developing improved live vaccines for poultry, and especially for those enhancing the safety of the food supply by diminishing the transmission of human enteropathogens via poultry and eggs. We have genetically engineered Salmonella serovar Typhimurium vaccines for regulated delayed attenuation in vivo and regulated delayed in vivo synthesis of protective antigens specified by codon-optimized DNA sequences from multiple pathogens. The genes for these antigens are encoded on plasmids establishing a balanced-lethal vector-host relationship. Such strains can be grown under conditions that enable the vaccines to display, after oral immunization, the capabilities of a wild-type strain to survive host defense stresses, and efficiently colonize lymphoid effector tissues before manifesting attenuation to preclude causing disease symptoms and synthesizing protein antigens to induce protective immune responses. We have also developed a means for regulated delayed lysis in vivo to 64
on Vaccine Research ABSTRACTS OF INVITED PRESENTATIONS exhibit biological containment to preclude persistence in vivo or survival if excreted. This system can be used to deliver a bolus of protective antigen upon lysis or to lyse after escape from the endosome in the cytosol to deliver a DNA vaccine encoding protective antigens that is targeted to the nucleus for efficient transcription. Vaccines for poultry must provide an economic benefit to producers to ensure their use. Thus, all of our recombinant attenuated Salmonella vaccines not only reduce infection by S. enterica serotypes but are designed to protect against Escherichia coli pathovars (APEC & ExPEC), Clostridium perfringens causing necrotic enteritis or Eimeria species causing coccidiosis. Research supported by grants from the Ellison Medical Foundation, National Institutes of Health and United States Department of Agriculture. References: 1. Kong W, Wanda SY, Zhang X, et al. Regulated programmed lysis of recombinant Salmonella in host tissues to release protective antigens and confer biological containment. Proc Natl Acad Sci U S A. 2008;105(27):9361-66. 2. Konjufca V, Jenkins M, Wang S, Juarez-Rodriguez MD, Curtiss R 3rd. Immunogenicity of recombinant attenuated Salmonella enterica serovar Typhimurium vaccine strains carrying a gene that encodes Eimeria tenella antigen SO7. Infect Immun. 2008;76(12):5745-53. 3. Curtiss R 3rd, Wanda SY, Gunn BM, et al. Salmonella strains with regulated delayed attenuation in vivo. Infect Immun. 2009;77(3):1071-82. 4. Curtiss R 3rd, Xin W, Li Y, et al. New technologies in using recombinant attenuated Salmonella vaccine vectors. Crit Rev Immunol 2010;30(3):255-70.
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Control of Verotoxigenic Escherichia coli Colonization of Cattle by Vaccination: Threats and Opportunities Andrew A. Potter, PhD VIDO-InterVac Saskatoon, Canada
Objective: Discuss the mechanism of adherence by verotoxigenic E. coli strains in cattle and the development of vaccines which are able to block colonization of cattle by multiple serotypes of the organism in both experimental and field conditions as a means of reducing the risk of human exposure. Abstract: Verotoxigenic Escherichia coli O157:H7 are important zoonotic pathogens, causing hemorrhagic colitis and haemolytic uremic syndrome (HUS). Colonization of cattle, the primary reservoir of the organism, and human hosts is mediated through the action of effector molecules secreted via a type III secretion system (TTSS). The structural genes for the TTSS and many of the secreted effectors are located on a pathogenicity island called the locus of enterocyte effacement (LEE). Vaccines composed of Type III-secreted proteins have been shown to prevent colonization by serotype O157 strains1, 3. We cloned and purified the genes coding for 66 proteins from serotype O157, including 37 LEE proteins and 29 non-LEE effectors, and measured their serological reactivity using anti-O157 sera as well as sera against serotypes O111, O26, and O103. The results indicated that serological responses to both vaccination and natural infection were serotype-specific in nature2. An analysis of immune responses against the translocated intimin receptor (Tir) suggested that one reason for this was the
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The Fifteenth Annual Conference ABSTRACTS OF INVITED PRESENTATIONS recognition of different epitopes within the intimin-binding domain of the protein. A subset of effector proteins composed of EspA, EspB, EspA, NleA, and Tir from serotype O103 showed broader cross-serotype reactivity than those from serotype O157 and sera against these proteins was able to block adherence of the organism in vitro. The use of type III secreted effector molecules in a broadly protective VTEC vaccine for cattle will be discussed. References: 1. Allen KJ, Rogan D, Finlay BB, Potter A, Asper DJ. Vaccination with type III secreted proteins leads to decreased shedding in calves following experimental challenge with Escherichia coli O157:H7. Can J Vet Res. 2011;75(2):98-105. 2. Asper D J, Finlay BB, Karmali MA, Townsend H, Rogan D, Potter AA. Serological response of Shiga toxinproducing Escherichia coli (STEC) type III secreted proteins in sera from vaccinated rabbits, naturally infected cattle, and humans. Clin Vaccine Immunol. 2011;18(7):1052-7. 3. Potter A.A, Klashinsky S, Li Y, et al. Decreased shedding of Escherichia coli O157:H7 by cattle following vaccination with type III secreted proteins. Vaccine. 2004;22(3-4):362-9.
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How Vaccines Work Philippa Marrack, PhD Howard Hughes Medical Health Denver, CO
Objectives: Discuss the complex effects of the vaccine adjuvant alum, and discuss the abilities of alum to generate CD8 T cell memory. Describe a potentially cross-reactive vaccine against influenza virus. Understand the mechanisms underlying alum’s action as a vaccine adjuvant. Abstract: Despite the fact that alum has been used as a vaccine adjuvant for 80 years we still know very little about how the material functions. It is clear that alum has many effects in the body: it activates the NALP3 inflammasome, leading to production of IL-1; it creates leaky lysosomes in cells that have injected it, it produces granulomas and attracts neutrophils and eosinophils; and, it may interfere with the normal structure of plasma membranes. Nevertheless, it is controversial which of these effects, if any, are essential for the useful function of alum and related salts in vaccines. We have been studying the effects of alum in mice for some time. During this talk we will present data that show that, unexpectedly, alum primes CD8 T cells in addition to its well-known effects on CD4 T cells and B cells. This ability of alum to induce cytotoxic T cells and memory Cd8 cells can be harnessed to create a vaccine that cross reacts between different strains of influenza. The means by which alum manages these effects will be discussed. References: 1. McKee AS, Munks MW, MacLeod M, et al. Alum induces innate immune responses through macrophage and mast cell sensors, but these are not required for alum to act as an adjuvant for specific immunity. J Immunol. 2009;183(7):4403-14. 2. Munks MW, McKee AS, MacLeod MK, et al. Aluminum adjuvants elicit fibrin-dependent extracellular traps in vivo. Blood. 2010;116(24):5191-9. 3. MacLeod MK, McKee AS, David A, et al. Vaccine adjuvants aluminum and monophosphoryl lipid A provide distinct signals to generate protective cytotoxic memory CD8 T cells. Proc Natl Acad Sci U S A. 2011;108(19):7914-9. 66
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Systems Vaccinology Bali Pulendran, PhD Emory Vaccine Center Atlanta, GA
Objective: Discuss the emerging role of systems biological approaches in understanding the molecular mechanisms of immune responses to vaccination, uncovering correlates of protective immunity, and predicting the efficacy of vaccines. Abstract: Despite their great success, we understand little about how effective vaccines stimulate protective immune responses. Two recent developments promise to yield such understanding: the appreciation of the crucial role of the innate immune system in sensing microorganisms and tuning immune responses, and advances in systems biology. In this presentation, I will discuss how these developments are yielding insights into the mechanism of some of the most successful vaccines ever developed. Furthermore, such developments promise to address a major challenge in vaccinology: that the efficacy of a vaccine can only be ascertained retrospectively, upon infection. The identification of molecular signatures induced rapidly after vaccination, which correlate with and predict the later development of protective immune responses, would represent a strategy to prospectively determine vaccine efficacy. Such a strategy would be particularly useful when evaluating the efficacy or immunogenicity of untested vaccines, or in identifying individuals with sub-optimal responses amongst high risk populations, such as infants or the elderly. We have recently used a systems biology approach to identify early gene signatures that correlate with and predict the later immune responses in humans vaccinated with the live attenuated yellow fever vaccine YF-17D, or with the influenza vaccines. These studies will be reviewed, and their broader implications for vaccinology will be discussed. References: 1. Pulendran B, Li S, Nakaya HI. Systems vaccinology. Immunity. 2010;33(4):516-29. 2. Querec TD, Akondy RS, Lee EK, et al. Systems biology approach predicts immunogenicity of the yellow fever vaccine in humans. Nat Immunol. 2009;10(1):116-25. 3. Pulendran B, Ahmed R. Immunological mechanisms of vaccination. Nat Immunol. 2011;12(6):509-17. 4. Nakaya HI, Wrammert J, Lee EK, et al. Systems biology of vaccination for seasonal influenza in humans. Nat Immunol. 2011;12(8):786-95.
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Vaccine Adjuvants Improve Humoral and Cellular Immunity Robert A. Seder, MD Vaccine Research Center, NIAID, NIH Bethesda, MD
Objective: Explain how adjuvants and formulation enhance the magnitude and quality of antibody and T cell immunity when administered with protein vaccines. Abstract: Highly successful vaccines against HIV, malaria, and tuberculosis will require generation of antibody, T cell immunity, or both. Generation of such broad based immune responses that will induce durable immunity may require different types of vaccine platforms. In this regard, viral vectors are potent for eliciting T cell immunity and protein vaccines used for humoral immunity. Over the past several years improvement in the delivery and formulation of protein vaccines have increased their potency for T cell immunity as well as alter the
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The Fifteenth Annual Conference ABSTRACTS OF INVITED PRESENTATIONS qualitative aspects of humoral immunity. Therefore, protein based vaccines are now being used in combination with viral vectors (e.g. HIV, malaria) or BCG (tuberculosis). The data presented will focus on protein vaccines administered with adjuvants that activate distinct innate immune pathways improve adaptive immunity. Reference: 1. Coffman RL, Sher A, Seder RA: Vaccine adjuvants: putting innate immunity to work. Immunity. 2010;33(4):492-503.
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Rational Design and Development of New Adjuvants Steven G. Reed, PhD Infectious Disease Research Institute Seattle, WA
Objective: Demonstrate the use of rational design to develop and test defined adjuvant formulations for next generation vaccines. Abstract: Safe and effective adjuvants for prophylactic and therapeutic vaccine use are resulting from the identification of small molecules and optimization of their formulations. For a new adjuvant to be widely accepted and used, however, non-clinical safety and efficacy are not the only important aspects to be considered. Also helpful are detailed knowledge of mechanism of action, local and systemic effects on immune activation, magnitude and duration of effects, as well as quality, manufacturability, and stability of the active ingredients and excipients used in the final adjuvant composition. Effectively engaging macrophages and dendritic cells (DC), leading to T cell responses is essential for developing a new generation of T cell vaccines (e.g. tuberculosis, malaria, HIV), as well as for improving the quality and duration of antibody responses (influenza, HPV, HIV, etc.). The most advanced approaches to new adjuvant development consist of using TLR ligands (TLRL), which, when properly formulated, can be used in minimal amounts to achieve desired effects. The manner in which TLRL are formulated dramatically influences the nature of the immune response they induced. We have developed formulations of synthetic of several TLR4L and have evaluated a variety of these, including oil/water emulsions, micellar, and liposomal, in non-clinical and clinical studies. Formulations have been developed with desirable adjuvant properties, adjustable potency, focused Th1 or balanced Th1/Th2 responses, down-regulation of Th2 responses, induction of CD8 T cells, induction of mucosal immune responses, and effective broadening of specific antibody responses. We have also shown that cells from elderly individuals strongly recognize formulated TLRL, producing cytokines in a manner qualitatively and quantitatively indistinguishable from cells from healthy adults. Thus, selective molecular synthesis and formulation may lead to a new generation of TLR4Lbased adjuvants with improved qualities over natural products. Non-clinical and clinical data using these and other novel adjuvants in development will be discussed. References: 1. Coler RN, Bertholet S, Moutaftsi M, Guderian JA, Windish HP, Baldwin SL, Laughlin EM, Duthie MS, Fox CB, Carter D, Friede M, Vedvick TS, Reed SG. 2011. Development and characterization of synthetic glucopyranosyl lipid adjuvant system as a vaccine adjuvant. PLoS One. 26;6(1):e16333 2. Hayedeh Behzad, Anke L. W. Huckriede, Laura Haynes, Beth Gentleman, Krysta Coyle, Jan C. Wilschut, Tobias R. Kollmann, Steven G. Reed, and Janet E. McElhaney. GLA-SE, a Synthetic Toll-like Receptor 4 Agonist, Enhances T-Cell Responses to Influenza Vaccine in Older Adults. J Inf. Dis. 2012 (in press). 3. Baudner BC, Ronconi V, Casini D, Tortoli M, Kazzaz J, Singh M, Hawkins LD, Wack A, O’Hagan DT: MF59 emulsion is an effective delivery system for a synthetic TLR4 agonist (E6020). Pharm Res. 2009 Jun; 26(6):1477-85. Epub 2009 Mar 3. 68
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Understanding Narcolepsy in the Context of Pandemic Influenza Vaccination Emmanuel Mignot, MD, PhD Stanford University Palo Alto, CA
Objective: Review current data on the pathophysiology of narcolepsy and the occurrence of new onset cases in relation to H1N1. Abstract: Narcolepsy-cataplexy, a disabling and life-long sleep disorder (prevalence~0.03%), is caused by the loss of ~70,000 hypocretin producing neurons in the hypothalamus.1 Disease onset is typically in adolescence, although, since 2010, young children have been frequently reported. Onset is seasonal (spring/summer) and often associated with a past history of strep throat infections. Narcolepsy is tightly associated with DQA1*0102/DQB1*0602 (~99% versus 25%), indicating that antigen presentation by DQ0602 is crucial.2,3 We also found a strong association with the T cell receptor alpha locus (OR~2, p~10-33 in current GWAS).3 Other unpublished GWAS hits are also suggestive of antigen presentation and T cell response, for example CTSH (an antigen processing cathepsin) and OX40L (a costimulatory molecule). In spite of these results, however, there has been no evidence for autoantibodies or T cell responses against hypocretin or hypocretin cell enriched proteins. Recent studies have reported increased risk of narcolepsy following Pandemrix™ a pH1N1 AS03 (squalene-alpha tocopherol) adjuvanted GSK vaccine that was used in 2009-2010. In Sweden and Finland where a large portion of the population was vaccinated, this has created a significant health crisis. Most cases are children and have started narcolepsy abruptly ~2 months following vaccination.4,5 Similar to sporadic cases, post-Pandemix™ cases carry DQB1*06:02 and have hypocretin deficiency. In children, the disease may be triggered by pH1N1 vaccination, but also by pH1N1 infections, as a three-fold increase in incidence was observed following the 2009 flu season in China. We now suggest that two factors are promoting the development of narcolepsy (i) a specific immune-mimicry component, mediated through the presentation by DQ0602 of an epitope contained in pH1N1 and other flu strains to a specific TCR idiotype, and (ii) non-DQ0602-related contributors, such as adjuvants, fever or streptococcal infections, streptococcal superantigens, and other factors. Non-specific effects may also involve reactivation of dormant T cell clones, increased blood brain barrier penetration of immune responses by adjuvants or superantigens. It is also possible that in Pandemrix™ cases, the adjuvant is only precipitating temporary risk among younger children but does not increase lifelong risk. References: 1. Peyron C, Faraco J, Rogers W, et al. A mutation in a case of early onset narcolepsy and a generalized absence of hypocretin peptides in human narcoleptic brains. Nat Med. 2000;6(9):991-7. 2. Mignot E, Lin L, Rogers W, et al. Complex HLA-DR and -DQ interactions confer risk of narcolepsy-cataplexy in three ethnic groups. Am J Hum Genet. 2001;68(3):686-99. 3. Hallmayer J, Faraco J, Lin L, et al. Narcolepsy is strongly associated with the T-cell receptor alpha locus. Nature Genet. 2009;41(6):708-11. 4. National Institute for Health and Welfare (Finland). Association between Pandemrix and narcolepsy confirmed among Finnish children and adolescents. Press release, September 1, 2011. http://www.thl.fi/ en_US/web/en/pressrelease?id=26352. 5. Medical Products Agency (Sweden). A registry based comparative cohort study in four Swedish counties of the risk for narcolepsy after vaccination with Pandemrix - A first and preliminary report. March 28, 2011. http://www.lakemedelsverket.se/upload/nyheter/2011/PandemrixRegReport110328.pdf. 6. Han F, Lin L, Warby SC, et al. Narcolepsy onset is seasonal and increased following the 2009 H1N1 pandemic in China. Ann Neurol. 2011;70(3):410-7.
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Acute Viscerotropic Disease in the Context of Yellow Fever Vaccination J. Erin Staples, MD, PhD Centers for Disease Control and Prevention Fort Collins, CO
Objectives: Discuss cases of yellow fever vaccine-associated viscerotropic disease (YEL-AVD). Identify potential risk factors for YEL-AVD. Describe current and future initiatives related to YEL-AVD. Abstract: Yellow fever (YF) is a vector-borne disease resulting from the transmission of YF virus to a human from the bite of an infected mosquito. It is endemic to sub-Saharan Africa and tropical South America. Clinical disease varies from a mild, undifferentiated febrile illness to severe disease with jaundice and hemorrhagic manifestations. The case fatality rate is 20-50% for persons with severe disease. Because no treatment exists for YF disease, prevention through avoiding mosquito bites and being vaccinated is critical to lower disease risk and mortality. YF vaccine is recommended for persons aged ≥ 9 months who are traveling to or living in areas at risk for YF virus transmission. Rare serious adverse events have been noted to occur following YF vaccine administration, including vaccine-associated viscerotropic disease (YEL-AVD). YEL-AVD mimics naturally acquired YF disease, with the vaccine virus proliferating and disseminating throughout the host’s tissues. Since YEL-AVD was first recognized in 2001, more than 60 cases have been reported globally. Based on data from Vaccine Adverse Event Reporting System (VAERS), the incidence of YEL-AVD in the US is 0.3-0.4 per 100,000 doses distributed. Older age and thymic disease have been identified as risk factors for YEL-AVD. Because of the risk of serious adverse events, such as YEL-AVD, health-care providers should vaccinate only persons who are at risk for exposure to YF virus or require proof of vaccination for country entry. References: 1. Hayes EB. Acute viscerotropic disease following vaccination against yellow fever. Trans Royal Soc Trop Med Hyg. 2007;101(10);967-71. 2. Lindsey NP, Schroeder BA, Miller ER, et al. Adverse events following yellow fever vaccination. Vaccine. 2008;26(48):6077-82. 3. Staples JE, Gershman M, Fischer M; Centers for Disease Control and Prevention (CDC). Yellow fever vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2010;59(RR7):1-27. 4. Whittembury A, Ramirez G, Hernández H, et al. Viscerotropic disease following yellow fever vaccination in Peru. Vaccine. 2009;27(43):5974-81.
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Adverse reactions to Squalene-Based Adjuvanted Influenza Vaccines in Special Risk Groups Claire-Anne Siegrist, MD, PD University of Geneva Geneva, Switzerland
Objective: Review the clinical experience collected using squalene-based influenza H1N1/A/09 pandemic vaccines in patients with variable levels of immune competence including HIV-infected patients, solid organ or hematopoietic stem cells transplant recipients, and patients with autoimmune diseases or cancer. Abstract: Eliciting protective influenza vaccine responses in immunocompromised patients may be challenging, suggesting a role for more potent novel adjuvant/delivery systems. However, it is biologically plausible that nonspecific immune activation (‘adjuvant effect’) may enhance or trigger immune responses against auto- or alloantigens. In a single-center prospective study, we evaluated 760/776 hematopoietic stem cells or solid organ transplants (274) and 133/138 healthy subjects after one (healthy) or two (patients) doses of AS03-adjuvanted influenza H1N1/A/09 vaccine. Primary reactogenicity endpoints were inflammatory reactions. Post-immunization clinical and biological biomarkers were compared to baseline values to identify immune-mediated disease enhancement or altered graft function. Adverse reactions, mostly local pain, were significantly less frequent in cancer (72.9%, 95%CI: 66.0-79.1), HIV-infected (77.7%, 95%CI: 69.2-84.8) and transplant (81.0%, 95%CI: 75.985.5) patients than in healthy individuals (88.0%, 95%CI: 81.2-93.0) and rheumatic disease patients (90.8%, 95%CI: 85.4-94.6). Biomarkers of autoimmune disease activity and graft function remained unaffected. However, anti-HLA antibodies were newly identified in 16/106 (15.1%) previously seronegative kidney transplant recipients and HIV-RNA became detectable (median 1.76 log10 copies/ml) in 40/69 (58.0%) treated, previously aviremic patients. These observations will be presented and discussed in the context of other clinical studies. References: 1. Katerinis I, Hadaya K, Duquesnoy R, et al. De novo anti-HLA antibody after pandemic H1N1 and seasonal influenza immunization in kidney transplant recipients. Am J Transplant. 2011;11(8):1727-33. 2. Mohty B, Bel M, Vukicevic M, et al. Graft-versus-host disease is the major determinant of humoral responses to the AS03-adjuvanted influenza A/09/H1N1 vaccine in allogeneic hematopoietic stem cell transplant recipients. Haematologica. 2011;96(6):896-904. 3. Gabay C, Bel M, Combescure C, et al. Impact of synthetic and biologic disease-modifying antirheumatic drugs on antibody responses to the AS03-adjuvanted pandemic influenza vaccine: a prospective, openlabel, parallel-cohort, single-center study. Arthritis Rheum. 2011;63(6):1486-96. 4. Hottinger AF, George AC, Bel M, et al, on behalf of the H1N1 Study Group. A prospective study of the factors shaping antibody responses to the AS03-adjuvanted influenza A/H1N1 vaccine in cancer outpatients. Oncologist. 2012 Feb 21 [Epub ahead of print]. 5. Calmy A, Bel M, Nguyen A, et al. Strong serological responses and HIV RNA increase following AS03adjuvanted pandemic immunization in HIV-infected patients. HIV Med. 2012;13(4):207-18. 6. Siegrist CA, Ambrosioni J, Bel M, et al. Responses of solid organ transplant recipients to the AS03adjuvanted pandemic influenza vaccine. Antivir Ther. 2012 (in press).
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Recombinant Oligomeric HA1 Vaccine Generates Higher Affinity Antibodies than Subunit H5N1 Vaccine Resulting in Reduced Viral Loads Following Heterologous H5N1 Challenge in Ferrets S. Verma1, M. Dimitrova1, T. M. Ross2, S. Khurana1, H. Golding1 1 Division of Viral Products, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), Bethesda, MD, 2Center for Vaccine Research, University of Pittsburgh, Pittsburgh, PA
Objective: Compare the functionality, immunogenicity, and protective efficacy of functional oligomeric and monomeric HA1 vaccines derived from H5N1 (A/Vietnam/1203/04) vs. the licensed subunit H5N1 (SU-H5N1) vaccine in ferrets. Background: Recombinant hemagglutinins from influenza viruses can be produced rapidly in various cell substrates in response to influenza pandemic threat. We demonstrated that HA1 globular domains from multiple influenza strains produced in E. coli without the HA2 stalk domain contain high percentage of oligomeric species. Methods: Ferrets were vaccinated twice with oligomeric or monomeric HA1 as well as subunit H5N1 (sanofi pasteur) mixed with Titermax® adjuvant. Ferrets were challenged with homologous (A/Vietnam/1203/04; clade1) or heterologous (A/Whooperswan/Mongolia/244/2005; clade2.2) virus and monitored for lethality, weight loss, sickness score, and viral loads in the nasal washes. Results: Only the oligomeric HA1 (but not monomeric HA1) immunogen, and the SU-H5N1 vaccine provided homologous and heterologous protection from lethality and morbidity. However, viral loads after heterologous challenge were most efficiently controlled in animals vaccinated with the oligomeric HA1 immunogen and much less in SU-H5N1 vaccinated animals. Surface plasmon resonance (SPR) analyses revealed that ferrets vaccinated with oligomeric fraction generated significantly higher total binding antibodies with higher avidity (slower off-rates) for HA1 (1-330) compared with the SU-H5N1 immune sera. Heterologous H5N1 viral load reduction correlated with higher binding avidity of antibodies to oligomeric HA1 in SPR. Conclusion: Our study suggests that generation of high avidity antibodies targeting the HA1 globular domain contribute to control of viral replication following heterologous challenge. Oligomeric influenza vaccines based on HA1 globular domain generate high affinity antibodies with the capacity to neutralize heterologous strains and control virus replication in the upper respiratory tract and the lungs. References: 1. Khurana S, Verma S, Verma N, et al. Bacterial HA1 vaccine against pandemic H5N1 influenza virus: evidence of oligomerization, hemagglutination, cross-protective immunity in ferrets. J Virol. 2011;85(3):1246-56. 2. Khurana S, Verma S, Verma N, et al. Properly folded bacterially expressed H1N1 hemagglutinin globular head and ectodomain vaccines protect ferrets against H1N1 pandemic influenza virus. PLoS One. 2010;5(7):e11548.
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Preclinical Studies of Live Attenuated Non-Typhoidal Salmonella Vaccines Including Safety in SIVInfected Rhesus Macaques S. M. Tennant1, A. Ault2, J. Wang1, J. E. Galen1, S. Livio1, R. Simon1, M. Pasetti1, O. Gat1, J. P. Gorres2, J. Estes3, M. Eckhaus4, N. Sandler5, D. Douek5, S. Bao2, K. Foulds4, M. Roederer4, S. Kao4, G. Nabel2, S. S. Rao2, M. M. Levine1 1 Center for Vaccine Development, University of Maryland Baltimore, Baltimore, MD, 2Vaccine Research Center, NIAID, NIH, Bethesda, MD, 3AIDS and Cancer Virus program, Science Applications International Corporation-Frederick, Inc, National Cancer Institute, Frederick, MD, 4Veterinary Resources Program, Office of Research Services, NIH, Bethesda, MD, 5Human Immunology Section, Vaccine Research Center, NIAID, NIH, Bethesda, MD
Objectives: Review proposed live oral attenuated non-typhoidal Salmonella vaccines that have been shown to be safe and effective in preclinical studies. Understand invasive disease due to non-typhoidal Salmonella in subSaharan Africa. Background: While non-typhoidal Salmonella (NTS) have long been known to be a cause of self-limited gastroenteritis, it is becoming increasingly recognized that multiple antibiotic-resistant strains are also emerging as important causes of invasive bacteremia and focal infections, resulting in hospitalizations and deaths. Surveys from multiple sites in sub-Saharan Africa reveal that ~ 80-90% of NTS from cases of invasive disease include the Salmonella enterica group B serovars Salmonella Typhimurium or the monophasic variant S. I 4,[5],12:i:-, or the group D serovar Salmonella Enteritidis. Thus, an effective NTS vaccine directed against these serovars could provide broad protection. Methods: We have constructed live attenuated NTS vaccines by deleting the guaBA and clpP genes from S. Typhimurium and S. Enteritidis strains isolated from the blood of toddlers in Mali, West Africa. The phenotypes of the NTS strains were verified by SDS-PAGE, Western blot and by motility tests. The live oral vaccines were tested for safety, immunogenicity, and ability to protect against a lethal challenge in BALB/c mice, and also for their safety in chronically SIV-infected rhesus macaques. Results: Oral LD50 analysis of the recombinant NTS candidate vaccines showed that they were highly attenuated in mice. Oral immunization with 109 CFU of the attenuated S. Typhimurium and S. Enteritidis strains elicited antiLPS and anti-flagella IgG responses and protected mice against oral lethal challenge with the parental wild-type strains. The live-attenuated S. Typhimurium vaccine strain was safe and well-tolerated in chronically SIV-infected rhesus macaques. Conclusion: Live attenuated S. Typhimurium and S. Enteritidis vaccines carrying deletions in guaBA and clpP were both attenuated and protective in mice, and also proved safe in SIV-infected rhesus macaques. References: 1. Tennant SM, Wang JY, Galen JE, et al. Engineering and pre-clinical evaluation of attenuated non-typhoidal Salmonella strains serving as live oral vaccines and as reagent strains. Infect Immun. 2011;79(10):417585. 2. Tennant SM, Diallo S, Levy H, et al. Identification by PCR of non-typhoidal Salmonella enterica serovars associated with invasive infections among febrile patients in Mali. PLoS Negl Trop Dis. 2010;4(3):e621.
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Novel Structurally Designed Vaccine for S. aureus a-Hemolysin: Protection against Bacteremia/Sepsis and Pneumonia M. Aman, H. Karauzum, R. P. Adhikari, J. Sarwar, L. Abaandou, M. Mahmoudieh, H. Vu, A. RezaeiBoroun, S. Shulenin, T. Nguyen, S.Venkataramani, K. L. Warfield Integrated BioTherapeutics, Gaithersburg, MD
Objective: Describe a novel vaccine candidate for S. aureus. Background: Staphylococcus aureus is a Gram-positive human pathogen that causes a wide range of infections from skin and soft tissue infections (SSTI) to life threatening sepsis and pneumonia. The pathogenicity of S. aureus is dependent on numerous virulence factors, including surface proteins and polysaccharides and secreted toxins. The latter cause tissue damage, promote bacterial dissemination, and enable the pathogen to evade the host innate immune response. The pore-forming alpha-hemolysin (Hla) is produced by nearly all strains and is implicated in several S. aureus diseases including SSTI and pneumonia. Methods: Using a rational approach based on Hla crystal structure we designed two vaccine candidates and compared the structural integrity and protective efficacy of these vaccines with a previously described truncated antigen consisting of amino acids 1-50 of Hla. The vaccine candidates were biochemically characterized and tested in infection models of S. aureus bacteremia and pneumonia. Results: Polyclonal antibodies raised against the antigen effectively blocked Hla induced lysis of red blood cells and inhibited Hla oligomerization. Vaccinations with the lead antigen (referred to as AT62) along with IDC-1001 or alum as adjuvant in mice resulted in protection from lethal pneumonia and bacteremia by the S. aureus strains USA300 and Newman. Furthermore, vaccination with AT62 resulted in protection from Hla toxicity in a dermal necrosis model. Passive immunization with polyclonal antibodies against AT62 resulted in 3-5 logs reduction in bacterial burden in blood, lung, spleen, liver, and kidneys. Conclusion: The data strongly indicate that effective vaccine preparations against S. aureus must contain an Hla-based antigen and the rationally designed AT62 antigen described here represents a unique and excellent candidate as a component for a multivalent S. aureus vaccine. Reference: 1. Kennedy AD, Bubeck Wardenburg J, Gardner DJ, et al. Targeting of alpha-hemolysin by active or passive immunization decreases severity of USA300 skin infection in a mouse model. J Infect Dis. 2010;202(7):1050-8.
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NDV-3, a Recombinant Alum-Adjuvanted Vaccine for Candida and Staphylococcus aureus is Safe and Immunogenic in Healthy Adults J. P. Hennessey, Jr.1, C. S. Schmidt1, C. J. White2, A. S. Ibrahim3, S. G. Filler3, M. R. Yeaman4, Y. Fu3, J. E. Edwards, Jr.3 1 NovaDigm Therapeutics, Grand Forks, ND, 2CJW Consulting, Ambler, PA, 3Infectious Disease, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA, 4Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA
Objectives: Understand the safety, tolerability, and immune response generated against a complex fungal antigen. Review cross-protection against diverse pathogens induced by one antigen. Background: Staphylococcus aureus (Staph) and Candida albicans are the second and fourth most common
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The Fifteenth Annual Conference ABSTRACTS OF SUBMITTED ORAL PRESENTATIONS causes of hospital-acquired infections in the US and together account for over 40,000 deaths per year in the US.1 There are no licensed vaccines for either of these pathogens. NDV-3 is one of several candidates in clinical development for Staph, but is one of only two candidates being evaluated for Candida. The primary antigen in NDV-3 is a recombinant form of the N-terminal portion of the C. albicans agglutinin-like sequence protein 3 (Als3). Most healthy non-vaccinated adults have a pre-existing immune response to Als32 and non-human primates show a substantial boost in anti-Als3 IgG after receiving one dose of vaccine. Methods: A double-blind, placebo-controlled clinical trial evaluated safety, tolerability, and immunogenicity of one dose of the vaccine at two dose levels out to six months post-vaccination, and a second dose given at six months post-dose one (PD1) out to 90 days PD2. The immunogenicity end-points for this study were a statistically significant increase (Mann-Whitney test) in fold-rise antibody titer and increased cytokine production levels in a high percent of subjects. Results: NDV-3 is safe and well-tolerated at both dose levels PD1 and PD2. Serum anti-Als3 antibodies reached peak titers by day 14, with significantly higher titers in recipients of the higher dose, though the lower dose produced higher PD2 titers than the higher dose. Als3-stimulated PBMC production of IL-17 and IFN-γ was observed in most of subjects, with a faster, more robust response in those receiving the higher dose. Conclusion: The NDV-3 vaccine is safe and well-tolerated and induces robust B- and T-cell immune responses in healthy adults. References: 1. Hidron AI, Edwards JR, Patel J, et al. Antimicrobial-resistant pathogens associated with healthcareassociated infections: annual summary of data reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention, 2006-2007. Infect Control Hosp Epidem. 2008;29(11):996-1011. 2. Baquir B, Lin L, Ibrahim AS, et al. Immunological reactivity of blood from healthy humans to the rAls3p-N vaccine protein. J Infect Dis. 2010;201(3):473-7.
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Pfs25-EPA/Alhydrogel, a Transmission Blocking Vaccine against Falciparum Malaria R. D. Ellis LMIV/NIAID/NIH, Rockville, MD
Objectives: Review transmission blocking vaccines as a tool to interrupt malaria transmission. Discuss the clinical developments underway for Pfs25-EPA conjugate vaccine. Background: Transmission blocking vaccines are designed to work by inducing antibodies in vaccinated individuals that inhibit the development of malaria parasites in the mosquito, thus interrupting the cycle of transmission to the next human host. The target population of a vaccine to interrupt malaria transmission is all potentially infected members of a community. Pfs25 has previously been shown to induce antibody which inhibits parasite development in a standard membrane feeding assay (SMFA), but an immunogenic formulation safe for human use has been lacking. EPA as a conjugate has been shown to enhance immunogenicity and to be safe in humans. Pfs25 and EPA were chemically conjugated and adjuvanted with Alhydrogel®. Methods: A dose-escalating first-in-human trial in malaria naïve adults is being conducted. Thirty participants have received up to three doses of 8, 16, or 47 µg of Pfs25. Endpoints are the frequency and severity of adverse events, and immunogenicity assessed by ELISA and activity of the induced antibody in the SMFA. 76
on Vaccine Research ABSTRACTS OF SUBMITTED ORAL PRESENTATIONS Results: All adverse events related to vaccination have been mild or moderate. Local adverse events have been mostly mild, with pain and injection site erythema most frequent. Few related systemic adverse events have occurred and all have been mild. Immunogenicity data will be presented, including antibody activity in the SMFA. Conclusion: Pfs25-EPA/Alhydrogel® is a safe formulation of a transmission blocking vaccine. Clinical development requires demonstration of safety and immunogenicity in malaria exposed adults and children, and demonstration of a reduction in mosquito infectivity under field conditions. A Phase 1b study will assess initial safety and immunogenicity in malaria exposed adults, with transmission blocking activity assessed by membrane and direct skin feeds. References: 1. Wu Y, Ellis RD, Shaffer D, et al. Phase 1 trial of malaria transmission blocking vaccine candidates Pfs25 and Pvs25 formulated with montanide ISA 51. PLoS One. 2008;3(7):e2636. 2. Wu Y, Przysiecki C, Flanagan E, et al. Sustained high-titer antibody responses induced by conjugating a malarial vaccine candidate to outer-membrane protein complex. Proc Natl Acad Sci U S A. 2006;103(48):18243-8.
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Safety Signal Associated with Recombinant BCG Vaccination: Immunologic Clue or Chance Occurrence? D. F. Hoft1, A. Blazevic1, A. Selimovic1, A. Turan1, J. Tennant1, G. Abate1, J. Fulkerson2, R. Walker2, J. Scott2, J. Ishmukhamedov2, D. Hokey2, V. Dheenadhayalan2, L. Barker2, R. Wallis3, A. A. Gershon4, M. D. Gershon4, S. Steinberg1 1 Departments of Internal Medicine & Molecular Microbiology, Saint Louis University, St. Louis, MO, 2 Aeras Global TB Vaccine Foundation, Rockville, MD, 3Pfizer Global Research & Development, New London, CT, 4Columbia University, New York, NY
Objective: Discuss the results of the first-in-human trial of a new recombinant BCG vaccine, AERAS-422, overexpressing three key TB antigens (Ag85A, Ag85B, and Rv3407), and expressing mutant perfringolysin O. Background: Mycobacterium tuberculosis (Mtb) kills 1-2 million people annually and is increasingly drugresistant. New tuberculosis (TB) vaccines are needed. We conducted a first-in-human trial of a new recombinant BCG, AERAS-422, over-expressing 3 key TB antigens (Ag85A, Ag85B and Rv3407), and expressing mutant perfringolysin (PFOG137Q) designed to allow phagosomal membrane perforation and enhance CD8+ T cell immunogenicity. AERAS-422 was highly immunogenic in mice and nonhuman primates, and less virulent than non-recombinant BCG in SCID mice. Methods: HIV-negative, mycobacteria-naïve, healthy 18-40 year old volunteers were recruited into a doubleblind, dose-escalation trial of AERAS-422 (>105-106-2.2% (base case = 16%) or cost less than $33.09 per person per year (base case = $4.6). Probabilistic sensitivity analysis results, varying all parameter values simultaneously, demonstrate that SOPs are favored in >91% of model iterations at a $50,000/QALY acceptability threshold. Conclusion: Both PPSV and influenza vaccination in outpatient settings facilitated by SOPs is a promising and economically favorable investment, with analysis results remaining robust to parameter variation over clinically plausible ranges. References: 1. Smith KJ, Lee BY, Nowalk MP, et al. Cost-effectiveness of dual influenza and pneumococcal vaccination in 50-year-olds. Vaccine. 2010;28(48):7620-5. 2. McKibben LJ, Stange PV, Sneller VP, et al. Advisory Committee on Immunization Practices. Use of standing orders programs to increase adult vaccination rates. MMWR Recomm Rep. 2000;49(RR-1):15-6.
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The Fifteenth Annual Conference ABSTRACTS OF SUBMITTED ORAL PRESENTATIONS
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Coverage from Ontario’s School-Based HPV Vaccination Program: The First Three Years S. Wilson1, T. Harris1, P. Sethi2, J. Fediurek1, S. L. Deeks1 1 Surveillance and Epidemiology, Public Health Ontario, Toronto, Ontario, Canada, 2Ministry of Health and Long Term Care, Toronto, Ontario, Canada
Objectives: Understand how HPV vaccination coverage is assessed. Describe factors that influence HPV coverage. Background: Ontario, Canada’s largest province (13.3 million), implemented a grade 8 school-based human papillomavirus (HPV) vaccination program for girls in the 2007/8 school year. Girls are eligible to receive the vaccine until the end of their grade 9 year (extended eligibility). The objectives of this evaluation were (1) To calculate provincial vaccine coverage for the first three program years; and (2) To receive Health Units’ (HU) feedback on local coverage assessment methods. Methods: Ontario’s 36 HUs were surveyed to obtain vaccine coverage information, including source of denominator data and use of local information systems. HU-reported HPV vaccine coverage was compared to coverage estimates obtained from two provincial systems: the Immunization Record Information System (IRIS) and the HPV reimbursement database, a system used to remunerate HUs for HPV vaccine doses administered. Results: 100% of HUs participated in the survey. The provincial coverage estimates using HU-reported data were: 51% (2007-2008), 58% (2008-2009), and a preliminary estimate of 54% for 2009-2010. Only 47-58% of HUs included information on extended eligibility signifying that provincial coverage will be an underestimate. Comparisons across the three data sources (survey, IRIS and reimbursement database) revealed significantly different coverage estimates. The most common source of denominator data used by HUs (27/36, 75%) were class or school lists, however independent schools were not always included by all HUs. Conclusion: To improve HPV vaccine coverage assessment in Ontario until other immunization information management systems are implemented we recommend: (1) Local generation of denominators using class lists, ensuring all eligible girls are represented; and (2) The use of IRIS for provincial coverage assessment using modified methods to ensure doses administered as part of the extended eligibility are captured. References: 1. Fairbrother G, Freed GL, Thompson JW. Measuring immunization coverage. Am J Prev Med. 2000;19(3 Suppl):78-88. 2. Dorleans F, Giambi C, Dematte L, et al; VENICE 2 Project Gatekeepers Group. The current state of introduction of human papillomavirus vaccination into national immunisation schedules in Europe: first results of the VENICE2 2010 survey. Euro Surveill. 2010;15(47).pii:19730.
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Smaller Pediatric Offices Have Higher In-Office Influenza Vaccination Rates S. L. Toback1, E. Rothstein2, P. Bhatt3, W. Carr4, X. Wu1, C. S. Ambrose1 1 MedImmune, LLC, Gaithersburg, MD, 2Pennridge Pediatric Associates, Sellersville, PA, 3Pediatric & Adolescent Medicine, Lock Haven, PA, 4Stafford Pediatrics, Stafford, VA
Objective: Describe characteristics and activities that correlate with influenza vaccination coverage in US pediatric offices. Background: Efficient delivery of influenza vaccines by office-based providers is critical given that all eligible children six months and older are recommended for influenza vaccination and there is limited time in which to deliver the vaccine each year.1
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on Vaccine Research ABSTRACTS OF SUBMITTED ORAL PRESENTATIONS Methods: A multi-year, observational study of US outpatient pediatric offices prospectively captured influenza vaccinations by age group and activities to increase vaccine uptake during the 2007-2008 through 2010-2011 influenza seasons. Offices were recruited from a random sample of the American Medical Association list of pediatricians. Vaccination coverage was calculated as the number of children vaccinated with at least one dose divided by the total number of children under the office’s care. For each season, office characteristics that were correlated with office-level coverage were evaluated qualitatively and with regression analyses. Results: Vaccination coverage for children six months to 18 years of age was assessed in 36, 76, 82, and 103 pediatric offices during the 2007-2008, 2008-2009, 2009-2010, and 2010-2011 influenza seasons, respectively. Across all four seasons, lower coverage rates were observed in offices with more children under their care; office-level vaccination coverage fell by 21% (P