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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Agenda - Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development

FDA's Center for Biologics Evaluation and Research, in cooperation with the National Institutes of Health's Division of Intramural Research within the National Institute of Allergy and Infectious Diseases and the World Health Organization, is holding this public workshop.

December 10 and 11, 2007
Bethesda, MD, USA

Agenda
Day 1 - December 10, 2007
8:00-8:30 am Registration (Cabinet and Judiciary Rooms)
8:30-8:35 am Introduction
Jerry Weir, PhD
Director, Division of Viral Products
Center for Biologics Evaluation and Research, FDA
8:35-9:00 am Welcome and opening address:

Jesse L. Goodman, MD, MPH
Director, Center for Biologics Evaluation and Research, FDA

Anthony S. Fauci, MD
Director, National Institute of Allergy and Infectious Diseases, NIH

David Wood, PhD
Coordinator, Quality Safety and Standards, WHO

9:00-11:30 am Session 1.   Correlates of protection against seasonal influenza
Moderator: Robert Couch, MD

9:00-9:30 Plenary talk: General overview of immunity to influenza A viruses in humans and surrogate markers of protection: Robert Couch, MD (Baylor College of Medicine)
9:35-10:05 Humoral immune responses: Viral targets of antibody-mediated immunity (description of serum and mucosal antibody responses that correlate with protection): Brian Murphy, MD (NIH)
10:10-10:25 Break
10:25-10:45 An evidence based review of the criteria for regulatory assessment of seasonal influenza vaccines: Tom Jefferson, MD (Cochrane Collaboration)
10:45-11:05 Cell mediated immunity: description of T cell responses that correlate with protection and epitope specificity of T cell responses in mice: Jack Bennink, PhD (NIH)
11:05-11:25 Cell mediated immune responses in humans following natural infection and vaccination: Harry Greenberg, MD (Stanford University School of Medicine)
11:30 am-1:00 pm Lunch (on your own)

1:00-5:15 pm Session 2.   Immune responses to avian influenza infections and vaccines for novel influenza viruses in humans
Moderator: Jacqueline Katz, PhD

1:00-1:30 Plenary talk: overview of avian influenza A viruses in humans (including virus heterogeneity): Nancy Cox, PhD (CDC)
1:35-2:05 Immune responses in poultry workers: Jacqueline Katz, PhD (CDC)
2:10-2:40 Immune responses to non-replicating avian influenza vaccines in clinical trials conducted in Europe: Maria Zambon, PhD (Health Protection Agency, UK)
2:45-3:15 Immune responses to non-replicating avian influenza vaccines in clinical trials conducted in the USA: David Cho, PhD, MPH (NIH)
3:15-3:30 Break
3:30-4:00 Evaluation of immune responses in clinical trials of live attenuated A/AA ca avian influenza virus vaccines: Ruth Karron, MD (Johns Hopkins University)
4:05-4:35 Immune responses to non-replicating avian influenza vaccines in clinical trials conducted in the rest of the world: Laszlo Palkonyay, MD (WHO)
4:40-5:00 H5N1 Infection of Humans: Frederick Hayden, MD (WHO)
5:15 pm Close of Day

Day 2 - December 11, 2007

8:00-8.30 Summary of Day 1: Robert Couch and Jacqueline Katz

8:30-10:45 am Session 3.   Assays to evaluate vaccine immunogenicity
Moderator: Maria Zambon, PhD

8:30-9:00 Limitations of current serologic assays to detect antibody responses to HA and NA: John Wood, PhD (NIBSC, United Kingdom)
9:00-9:30 Assays to evaluate cell mediated immunity: Guus Rimmelzwaan, PhD (Erasmus Medical Center, Netherlands)
9:30-10:45

Novel assays

      9:30-9:45     Pseudotyped viruses: Gary Nabel, MD, PhD (NIH)
      9:45-10:00   NA inhibition assays: Maryna Eichelberger, PhD (FDA)
    10:00-10:15   Phage display libraries: Hana Golding, PhD (FDA)
    10:15-10:30   M2-specific assays: Walter Gerhard, MD (Wistar Institute)
    10:30-10:45   Assays to evaluate T cell responses: Janet McElhaney, MD (University of British Columbia and University of Connecticut)

10:45-11:00 Break

11:00 am-12:30 pm   Session 4. Evaluation of avian influenza vaccine efficacy
Moderator: Kanta Subbarao, MD, MPH - introduction and overview of animal models of influenza (mouse, ferret, monkey)

11:15-11:45 Evaluation of immunogenicity and efficacy of non-replicating avian influenza vaccines following challenge with homologous and heterologous H5N1 viruses in animal models: Jackie Katz, PhD (CDC)
11:50-12:25 Evaluation of immunogenicity and efficacy of live attenuated avian influenza vaccines efficacy following challenge with homologous and heterologous H5N1 viruses: Kanta Subbarao, MD, MPH (NIH)
12:30-2:00 Lunch (on your own)
2:00-3:05 Session 4- Continued
2:00-2:20 Heterosubtypic immunity: Suzanne Epstein, PhD (FDA)
2:20-2:30 Challenge studies in humans: John Treanor, MD (University of Rochester)
2:35- 3:05 Use of surrogate measures of efficacy: Jerry Weir, PhD (FDA)
3:05-3:20 Break

3:20-4:40 pm   Panel Discussion Led by the moderators (Couch, Katz, Zambon, Subbarao) and panelists, Bob Belshe, MD (St Louis University), Ed Kilbourne, MD (NY Medical College), Wendy Keitel, MD (Baylor College of Medicine), and Peter Wright, MD (Vanderbilt)

4:40-5:10 pm   Wrap up:

Summary of sessions 3 and 4: Maria Zambon and Kanta Subbarao
Wrap up
5:30 pm Close of Day