FDA/NIH/WHO Public Workshop: Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development

December 10 and 11, 2007

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, held this public workshop which included discussions on: (1) Current knowledge regarding correlates of protection against seasonal influenza, (2) immune responses to avian influenza infections and vaccines for novel influenza viruses in humans, (3) assays to evaluate vaccine immunogenicity, and (4) evaluation of avian influenza vaccine efficacy. The goals of the public workshop were to: (1) Identify the gaps in our knowledge and abilities in addressing the unique challenges encountered in the development and evaluation of vaccines intended to protect against pandemic influenza, and (2) facilitate implementation of a global research agenda to improve efficacy assessment of pandemic influenza vaccines.

Agenda

FDA/NIH/WHO public workshop on immune correlates of protection against influenza A viruses in support of pandemic vaccine development, Bethesda, Maryland, US, December 10–11, 2007, Vaccine 26 (2008) 4299–4303 (PDF - 196 KB)

December 10 Transcripts
December 11 Transcripts

December 10 Webcast (Captioned) (RealPlayer)
December 11 Webcast (Captioned) (RealPlayer)
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Workshop Presentations

Day 1 - December 10, 2007

Introduction

• Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development (PDF - 51 KB) - Jerry Weir, PhD
• Welcome to the Workshop (PDF - 53 KB) - Jesse L. Goodman, MD, MPH
• Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development (PDF - 544 KB) - Anthony S. Fauci, MD

Session 1. Correlates of protection against seasonal influenza

• Seasonal Influenza: Immunity and Correlates/Surrogates of Immunity in Humans (PDF - 481 KB) - Robert Couch, MD
• Immunity to Influenza A Virus in Humans (PDF - 1.4 MB) - Brian Murphy, MD
• An evidence based review of the criteria for regulatory assessment of seasonal influenza vaccines (PDF - 41 KB) - Tom Jefferson, MD
• Cell mediated immunity to influenza in mice: T-cell specific responses that correlate with protection (PDF - 290 KB) - Jack Bennink, PhD
• Immune response in children and adults to influenza vaccination (PDF - 242 KB) - Harry Greenberg, MD

Session 2. Immune responses to avian influenza infections and vaccines for novel influenza viruses in humans

• Immune responses to non-replicating avian influenza vaccines - EU experience (PDF - 1 MB) - Maria Zambon, PhD
• Immune responses to non-replicating avian influenza vaccines in clinical trials conducted in the USA (PDF - 1 MB) - David Cho, PhD, MPH
• Evaluation of immune responses in clinical trials of live attenuated A/AA ca avian influenza virus vaccines (PDF - 22 KB) - Ruth Karron, MD
• Immune responses to non-replicating avian influenza vaccines in clinical trials conducted in other countries (PDF - 197 KB) - Laszlo Palkonyay, MD
• H5N1 Infection of Humans (PDF - 760 KB) - Frederick Hayden, MD

Summary of Day 1 (PDF - 26 KB) - Robert B. Couch, MD

Day 2 - December 11, 2007

Session 3. Assays to evaluate vaccine immunogenicity

• Limitations of current serologic assays to detect antibody responses to HA and NA (PDF - 559 KB) - John Wood, PhD
• Assays to evaluate cell mediated immunity (PDF - 1.86 MB) - Guus Rimmelzwaan, PhD
• Novel assays
  • Viral Neuraminidase (PDF - 650 KB) - Maryna Eichelberger, PhD
  • M2-specific assays (PDF - 101 KB) - Walter Gerhard, MD
  • Assays to evaluate T cell responses (PDF - 149 KB) - Janet McElhaney, MD

Session 4. Evaluation of avian influenza vaccine efficacy

• Introduction: Features of Animal Models of Influenza Infection (PDF - 73 KB) - Kanta Subbarao, MD, MPH and Catherine Luke, Ph.D.
• Immunogenicity and Efficacy of Live Attenuated Pandemic Influenza Vaccines: Preclinical Data (PDF - 379 KB) - Kanta Subbarao, MD, MPH
• Heterosubtypic immunity to Influenza A (PDF - 232 KB) - Suzanne Epstein, PhD
• Challenge studies in humans (PDF - 34 KB) - John Treanor, MD
• Use of surrogate measures of efficacy (PDF - 54 KB) - Jerry Weir, PhD

Panel Discussion (PDF - 18 KB)