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GAVI Task Force for R&D Pneumococcal Conjugate
Vaccine Agenda Meeting
Determining priority research activities to expedite
introduction of pneumococcal conjugate vaccines into infant immunization
programs in developing countries.
NIH, Bethesda, Washington
Agenda
19-20 April 2001
Meeting Objective: To
develop an agenda of research activities aimed at accelerating the
uptake of pneumococcal conjugate vaccine for routine infant immunization
in developing countries
Expected outcome:
The activities identified through this meeting, along with their
budgets, partners, and timeline, will form the Research and Development
(R&D) agenda. The R&D agenda will be integrated with similar
agendas from the other three GAVI task forces financing,
country coordination, and advocacy into a larger, comprehensive
agenda of activities necessary to accelerate the uptake of these
vaccines.
Meeting format:
Before the meeting, a background document summarizing previous and
current research on pneumococcal conjugate vaccines will be circulated
to the group, so little time will be spent during the meeting reviewing
this type of information. In addition, an outline of a draft agenda
including obstacles to introduction and proposed research areas
will also be sent to participants before the meeting. The meeting
will primarily be discussion, with sessions focused on the major
obstacles to vaccine introduction and research areas that need to
be addressed to overcome these obstacles. Each session will have
the following format:
- The moderator will briefly review background issues
relevant to the session
- The group will review whether the research areas
that are key to vaccine introduction have been included in the
draft research agenda outline
- For each research area, the group will delineate
needed activities, budget, and partners
Near the end of the meeting, the group will
discuss a timeline for the priority research areas.
After the meeting:
The R&D agenda will be combined with agendas that are concurrently
being developed by the other GAVI task forces (Country Coordination,
Advocacy, and Finance) into a comprehensive document that addresses
all activities needed to facilitate pneumococcal conjugate vaccine
introduction into developing countries. A meeting that included
members from all the task forces will be held in May to review and
approve the combined agenda.
Thursday 19
April |
Time |
Topic |
Moderators |
08:30 |
Registration |
09:00 |
Welcome and introductions |
Gary Nabel
Teresa Aguado |
09:15 |
Meeting goals and objectives
|
Myron Levine |
09:30 |
Framework for understanding the
vaccine introduction process: Lessons for Hib and other vaccines |
Orin Levine |
09:45 |
Disease burden: endpoints and advocacy
Defining disease burden
Establishing surveillance for pneumococcal meningitis, pneumonia,
and otitis media
Developing advocates to raise awareness of disease burden
and importance of vaccine
|
Anne Schuchat
Fred Binka |
11:15 |
Break |
11:30 |
Disease burden: diagnostics
Standardization of pneumonia diagnosis
Standardizing laboratory methods
Evaluating potential diagnostic tests
|
Richard Adegbola
Mark Steinhoff |
12:30 |
Lunch |
13:30 |
Safety and effectiveness: routine immunizations
Supporting ongoing and planned efficacy trials in developing
countries and evaluate need for additional trials
Studying herd immunity effect in developing countries, impact
of replacement, and effect on resistance
|
Mathuram Santosham
Jonathan Carapetis |
15:15 |
Break |
15:30 |
Safety and effectiveness: special populations
Evaluating safety and efficacy in special populations of
infants (HIV, sickle cell, low birth weight)
Strategies for preventing disease among very young infants
|
Hanna Nohynek
Yang Yong-Hong |
17:00 |
Adjourn |
Friday 20 April |
Time |
Topic |
Moderators |
08:30 |
Programmatic and feasibility concerns
Evaluating alternative dosing schedules
Evaluating immunogenicity of conjugate vaccine combinations
Post-introduction studies
|
Rosanna Lagos
Thomas Cherian |
10:30 |
Break |
10:45 |
Regulatory and licensing issues
Evaluating correlates of protection for invasive pneumococcal
infection
Getting appropriate products licensed
Establishing quality control requirements
|
Julie Milstien
David Klein |
12:00 |
Lunch |
13:00 |
Beyond routine infant immunization
Adult vaccination
Common protein vaccine
|
Keith Klugman
Margaret Liu |
14:00 |
Setting a time frame for priority
activities |
Orin Levine |
14:30 |
Summary and next steps |
15:00 |
Adjourn |
List of Participants
ABRAHAM, Dr Betsy,
Director, Global Medical Affairs-Vaccines, Wyeth Ayerst Pharmaceuticals,
USA
ADEGBOLA, Dr Richard,
Head of Pneumonia Research Programme, MRC Laboratories, Gambia
AGUADO, Dr M. -Teresa,
Coordinator, Vaccine Development, Vaccines and Biologicals, Health
Technology and Pharmaceuticals, World Health Organization
BIERNAUX, Sophie, Glaxo
Smithkline Biologicals, Belgium
BINKA, Dr Fred, University
of Ghana, School of Public Health, Ghana
CARAPETIS, Dr Jonathan,
Senior Lecturer, University of Melbourne, Department of Pediatrics,
Australia
CHERIAN, Dr Thomas,
Vaccines and Biologicals, Health Technology and Pharmaceuticals,
World Health Organization
DE CASTRO OLIVEIRA, Dr Marcos
Henrique*, Director, Bio-Manguinhos/Fiocruz
DI FABIO, Dr José Luis,
Advisor on Vaccine Research, Production & Quality, AMRO/PAHO
DOUGAN, Dr Gordon, Imperial
College of Science, Technology and Medicine, Department of Biochemistry,
United Kingdom
ESKOLA, Dr Juhani,
Aventis Pasteur, France
FREE, Dr Michael J,
Vice President and Senior Advisor for Technologies, PATH, USA
GLÜCK, Dr Reinhard*,
Director R&D, Swiss Serum & Vaccine Institute, Switzerland
GOLDBLATT, Dr David, University
College London Medical School, Institute of Child Health, United
Kingdom
HACKELL, Dr Jill, Wyeth
Lederle Vaccines, USA
HOLMGREN, Professor Jan*,
University of Göteborg, Department of Medical Microbiology
and Immunology, Sweden
HOMMA, Dr Akira, Vice
President of Technology, Manguinhos, Brazil
KILGORE, Dr Paul, Research
Epidermiologist, International Vaccine Institute, South Korea
KLEIN, Dr David, Program
Officer, Division of Microbiology and Infectious Diseases, NIAID,
USA
KLUGMAN, Keith P., Professor
of Infectious Diseases, Department of International Health, The
Rollins School of Public Health, Emory University, USA
KRISHNA, Dr Ella, Bharat
Biotech International Ltd, India
LAGOS, Dr Rosanna, Hospital
Roberto Del Rio, Centro para Vacunas en Desarollo, Servicio de Salud,
Chile
LEVINE, Professor Myron, Director,
Centre for Vaccine Development, University of Maryland, USA
LEVINE, Orin S, Epidemiologist,
NIH/CDC, USA
LIU, Dr Margaret, Senior
Advisor in Vaccinology, Bill & Melinda Gates Foundation, USA
LONG, Prof. Hoang Thuy*, Director
General, National Institute of Hygiene & Epidemiology,Vietnam
MALECKAR, Dr James, Pneumo
Conjugate Project Leader, Aventis Pasteur, France
MCINNES, Dr Pamela, Chief,
Respiratory Diseases, National Institute of Allergy & Infectious
Disease National Institutes for Health, USA
MIDTHUN, Dr Karen, Director,
OVRR, Food and drug Association, Centre for Biologics Evaluation
and Research, USA
MILSTIEN, Dr Julie,
Coordinator ATT, Vaccine and Biologicals, Health Technology and
Pharmaceuticals, World Health Organization
MOHSNI, Dr Ezzeddine*, EMRO/WHO
MULHOLLAND, Prof. Kim*, Royal
Children's Hospital, Department of Pediatrics, Australia
NABEL, Dr Gary J., Director,
Vaccine Research Center, NIAID/NIH, USA
NOHYNEK, Dr Hanna,
Senior Scientist, KTL National Public Health Institute, Department
of Vaccines, Finland
NOSSAL, Sir Gustav J.V*.,
Professor Emeritus, University of Melbourne, Department of Pathology,
Parkville, Australia
PITISUTTITHUM, Dr Punnee, Chief
of Clinical Infectious Diseases Research Unit, Mahidol University,
Thailand
POOLMAN, Dr Jan T., SmithKline
Beecham, rue de l'Institut 89, B-1330 Rixensart, Belgium Tel: 32
2 656 7109 Fax: 32 2 656 9131
RAPPUOLI, Dr Rino*,
Head of Research, Chiron, Italy
SANTOSHAM, Dr Mathuram, Johns
Hopkins School of Hygiene and Public Health, Centre for American
Indian Health, USA
SCHILD, Dr Geoffrey C.,
Director, WHO International Laboratory for Biological Standards,
National Institute for Biological Standards & Control, United
Kingdom
SCHUCHAT, Dr Anne, Chief,
Respiratory Diseases Branch, Centres for Disease Control and Prevention,
Division of Bacterial and Mycotic Diseases, National Centre for
Infectious Diseases, USA
SILBER, Dr Jeffrey L., Director,
Vaccine Clinical Research, Merck & Co, Inc., USA
SPIEGEL, Dr Richard, Bill
and Melinda Gates Childrens Vaccine Program, c/o PATH, USA
STEINHOFF, Prof. Mark,
Johns Hopkins School of Public Health, Department of International
Health, USA
SUZUKI, Dr Yasuhiro*, Executive
Director, Health Technology and Pharmaceuticals, World Health Organization
VAN BENEDEN, Dr Chris,
Respiratory Diseases Branch, Centers for Disease Control and Prevention,
USA
WARD, Dr Joel, UCLA
Center for Vaccine Research, USA
WENGER, Dr Jay*, Vaccines
& Biologicals, Health Technology and Pharmaceuticals, World
Health Organization
WHITNEY, Dr Cyndy, Respiratory
Diseases Branch, Centers for Disease Control and Prevention, Division
of Bacterial and Mycotic Diseases, National Center for Infectious
Diseases, USA
YONG-HONG, Yang, Deputy
Director, Beijing Childrens Hospital, China
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