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)

  • Presentation 

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

  • Presentation 

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

  • Presentation 

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

  • Presentation 

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

• Clinical and Laboratory markers (D. Cooper)

  • Presentation 

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

  • Presentation 

• Lessons from ART trials (J. Lange)

  • Presentation 

Session 3: Lessons from Animal models

Overview (Chair: J. Heeney)

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

• Biological/geographic/gender factors (E. Karita, C. Gray, M. Schechter)

  • Presentation 
  • Presentation 
  • Presentation 

• Virus Load in acute infection (K. Mlisana)

  • Presentation 

• Assay variability and standardization (H. Holmes)

  • Presentation 

• Host factors (A. Telenti)

  • Presentation 

Session 5: Virus load and Secondary Transmission

• Overview (Chair: M. Wawer)

  • Presentation 

• Mother-to-child transmission (G. Gray)

  • Presentation 

Thursday, 6 September

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

• Trial design and statistical considerations (S. Self)

  • Presentation 

• Regulatory considerations: FDA (C. Weiss)

  • Presentation 

• Regulatory considerations: South Africa (H. Rees)

  • Presentation 

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

• Key Questions (J. Kim)

  • Presentation 

• Ethical considerations (R. Macklin)

  • Presentation 

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

• Overview (Chair: R. Hecht)

  • Presentation 

• Modelling (D. Barth-Jones)

  • Presentation 

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

General discussion & recommendations