Global Consultation On Potential Endpoints of HIV Vaccine Efficacy

A World Health Organization (WHO) consultation organized jointly with the Agence Nationale de Recherches sur le Sida et les hépatites virales (ANRS) supported by the Global HIV Vaccine Enterprise.

5-6 September 2007, Paris, France

Wednesday, 5 September

Opening Remarks (Y. Levy, J. Esparza)

Session 1: Introduction (Chair: Y. Levy)

  • Presentation of Recommendations of the Geneva Meeting and Expected Outcomes (S. Osmanov)

  • State-of-the-art: potential trial outcomes (P. Johnston)

  • Current phase IIb/III trials: horizon scanning & timelines (L. Corey)

  • Overview presentation on correlates and surrogates (P. Gilbert)

Session 2: Approaches to Monitor Disease Progression (Chair: D. Cooper)

  • Clinical and Laboratory markers (D. Cooper)

  • Mortality and morbidity evolution of HIV infected patients: lessons of data from long term cohorts (G. Chene)

  • Lessons from ART trials (J. Lange)

Session 3: Lessons from Animal models

Overview (Chair: J. Heeney)

Session 4: Variability of Virus Load Setpoint (Chair: P. Kaleebu)

Session 5: Virus load and Secondary Transmission

Thursday, 6 September

Session 6: Definition of Vaccine Efficacy and Potential Outcomes (Chair: P. Johnston)

  • Trial design and statistical considerations (S. Self)

  • Regulatory considerations: FDA (C. Weiss)

  • Regulatory considerations: South Africa (H. Rees)

Session 7: HIV Vaccine Trials (Chair: P. Fast)

Session 8: Future Public Health Use of Vaccines with different outcomes

Session 9: Recommendations (Chairs: K. Goldenthal, H. Rees)

General discussion & recommendations

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