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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


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:

  1. The moderator will briefly review background issues relevant to the session

  2. The group will review whether the research areas that are key to vaccine introduction have been included in the draft research agenda outline

  3. 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

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

Disease burden: diagnostics

Standardization of pneumonia diagnosis

Standardizing laboratory methods

Evaluating potential diagnostic tests

Richard Adegbola
Mark Steinhoff
12:30 Lunch

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

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

Programmatic and feasibility concerns

Evaluating alternative dosing schedules

Evaluating immunogenicity of conjugate vaccine combinations

Post-introduction studies

Rosanna Lagos
Thomas Cherian
10:30 Break

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

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 Children’s 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 Children’s Hospital, China


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