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Pneumococcal Disease Prevention in Adults: Potential Vaccine Strategies
Agenda
September 9-10, 2003
Four Points Sheraton Hotel
Washington, DC
Sponsored by: National Vaccine Advisory Committee
Vaccine Conference
Pneumococcal Disease Prevention in Adults:
Potential Vaccine Strategies
September 9-10, 2003
Four Points Sheraton in Washington DC (K street)
Draft Agenda
Focus:
Identify gaps and discuss strategies in the effective protection of adults
against pneumococcal disease.
Objectives:
- To review current knowledge regarding pneumococcal disease in adults
and assess potential vaccine strategies for prevention.
- To explore biological and clinical trial design considerations for the
expanded use of current or future pneumococcal vaccines in adults.
Meeting Day 1
9:00 a.m. � 6:00 p.m.
Morning session
I. Introduction
- Goals of the meeting (15 minutes)
- Immunology (90 minutes)
Chair: Ann Arvin (Stanford University)
- Richard Insel (Juvenile
Diabetes Research Foundation International)
Basic and clinical immunology of pneumococcal vaccines.
- Donna Ambrosino (Massachusetts Biologic Laboratories/University of Massachusetts Medical School)
Immune responses (to polysaccharides) in immunosuppressed individuals.
Panel Discussion: Richard Insel, Donna Ambrosino, Ann Arvin
What does the basic immunology teach us for design of clinical trials:
Insights with respect to correlates and/or endpoints.
- Epidemiology (90 minutes)
Chair: Cynthia Whitney (Centers for Disease Control and Prevention,
[CDC])
- Cynthia Whitney (CDC)
Pneumococcal disease (invasive) in adults.
- Thomas Marrie (University of Alberta)
Community acquired pneumonia in adults.
- Alicia Fry (CDC)
Data and mathematical modeling of serotype coverage
- Possible serotype replacement
- Strengths & limitations of the model
- Trends in pneumococcal disease as population ages
Panel Discussion: Cynthia Whitney, Thomas Marrie, Alicia Fry
Profile of risk factors for pneumococcal disease.
II. Polysaccharide vaccine (PS): How much protection does a PS vaccine
provide against pneumoccoccal disease at various ages? (90 minutes)
Chair: Daniel Musher (Baylor College of Medicine and Veterans Affairs
Medical Center, Houston Texas)
- George Carlone (NCID/CDC)
- Methods for assessing level and biological activity of antibody levels
- Levels and biological activity after vaccination in adults of different ages
- David Fedson (Pasteur M�rieux MSD)
PS vaccine:
- Duration of protection
- Efficacy profile (invasive vs. non-invasive disease)
- New data
Panel discussion: Daniel Musher, David Fedson, George Carlone
Polysacharide vaccine strengths & weaknesses: revaccination, immune
correlates in adults
LUNCH
Afternoon Session
III. Conjugate vaccine: Could a conjugate vaccine of sufficient valency and
coverage protect adults against pneumococcal disease? (90 minutes)
Chair: David S. Stephens (Emory University
- Peter Paradiso (Wyeth)
Conjugate vaccines:
- Duration of immune response and breadth of immune response.
- Correlate of immunity in adults: what do we know?
- Sequential use of PS and conjugate; dose, duration, memory.
- James Watt (Johns Hopkins Bloomberg School of Public Health)
- Indirect effects- herd immunity
- Prevention of pneumococcal pneumonia, radiographic endpoints
Panel Discussion: David Stephens, Peter Paradiso and James Watt
Conjugate vaccine research needs and path forward. Can carriage of pathogen
or herd immunity be used as an endpoint? What is known about duration of
immunity?
IV. Pneumococcal protein vaccines (90 minutes)
Chair: Mark Steinhoff (Johns Hopkins School of Public Health)
- Mark Steinhoff (Johns Hopkins School of Public Health)
Review of the field of common protein vaccines
- David Briles (University of Alabama at Birmingham)
Rationale : Why should we have a protein Ag?
- Jan T. Poolman (GSK Biologicals)
Conjugates and proteins as part of the development of an adult pneumococcal vaccine
Elaine Wang (Aventis Pasteur, Ltd)
Development of the Aventis Pasteur pneumococcal protein vaccine
- Development and evaluation of new vaccine candidate
Panel Discussion: Mark Steinhoff, David Briles, Jan Poolman, Elaine Wang
Meeting Day 2:
8:30 a.m. � 12:30 p.m.
V. Trial Designs and Endpoints: What would it take to license a new
vaccine? What would it take to recommend a major new use for a licensed
vaccine?
Chair: Steve Black (Kaiser Permanente)
- Steve Black (Kaiser Permanente)
Several illustrative scenarios for the conduct of a pneumococcal conjugate
efficacy trial in adults.
- Jill Hackell (Wyeth)
Clinical Issues in Trial Design for a new pneumococcal vaccine.
- Robert Kohberger (Wyeth)
Specificity versus Sensitivity: Tradeoffs in Choice of Outcomes.
- Carl Frasch (Food and Drug Administration, [FDA])
FDA research and viewpoint on endpoints for licensure.
- Doug Pratt (FDA)
FDA's viewpoint on design of trials for licensure of new vaccines and
establishment of new indications for currently licensed vaccines.
- Brian Plikaytis (CDC)
Statistical considerations, non-inferiority
Panel Discussion: Steve Black, Jill Hackell, Robert Kohberger, Carl Frasch, Doug Pratt, Brian Plikaytis
VI. Summary and Overview of Issues
Benjamin Schwartz (CDC)
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