DESIGN APPROACHES FOR CURRENT AND FUTURE HIV PREVENTION EFFICACY TRIALS

VIRTUAL WORKSHOP SERIES
OCTOBER 2020 TO MAY 2021

Session 1 panel discussion focused on Current Efficacy Trial Design Approaches, looking at the challenges and lessons learned from three key trials:

  • Mosaico – in which Susan Buchbinder gave an introduction on the scientific and ethical rationale for the study, and Stephaun Wallace provided an expert opinion on the importance and benefits of community-informed involvement.
  • HPTN083 – Raphael Landovitz explained ‘where did we go right’ with this trial and Deborah Donnell, presents how the contingency plan, based on a counter-factual approach was designed to accommodate a non-inferiority result.
  • PrEPVacc – Eugene Ruzagira outlines the protocol for this Multi Arm Multi Steps study, and David Glidden discusses the study design and the use of a registrational cohort.

Session 2 includes three separate panel discussions on:

  • 2A) Future Design Approaches For Trials Of Antiretroviral-Based Prevention Strategies
  • 2B) Future Design Approaches for HIV Vaccine Efficacy Trials
  • 2C) Research pathway for the use of monoclonal antibodies in HIV prevention.

 These are accompanied by a series of pre-recorded talks examining how statistical challenges for inferring HIV incidence are being addressed and an example of how a surrogate endpoint is being used for the licensure of other vaccines.

In addition to a set of recordings from the HIVR4P conference in January 2021:

  • VRC01 Antibody Prevention of HIV –  Larry Corey
  • Antibody Mediated Prevention: Where To From Here? A Research for Prevention // Virtual event.

Session 3 looks collectively at future challenges firstly from a scientific perspective.

3A) Novel Scientific Approaches for Establishing Efficacy of New Biologics

Session 3A is accompanied by a series of presentations from the ID-PRISM seminar series, grappling with statistical challenges in a future where all trial participants have access to effective prevention. 

3B) Community engagement and involvement in clinical research

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