OCTOBER 2020 TO MAY 2021


Session 3: Future efficacy trial design approaches

HIV prevention is evolving rapidly with the roll out of new tools such as pre-exposure prophylaxis (PrEP) and treatment as prevention making a significant contribution towards controlling the epidemic.

As a result, the design and conduct of the next generation of prevention trials is impacted and is further affected by the outcomes of ongoing HIV prevention efficacy trials – including oral and injectable antiretrovirals, passively infused monoclonal antibodies, and HIV vaccines.

The third session of the virtual workshop aims to reflect on novel scientific approaches for establishing efficacy of new biologics, community involvement and meaning full participation in trial design and regulatory approval. This session is supported by online presentations and three panel discussions.

Session 3A: Novel Scientific Approaches for Establishing Efficacy of New Biologics.

Panel discussion on Novel Scientific Approaches for Establishing Efficacy of New Biologics

Chairs: Holly Janes and Deborah Donnell (Fred Hutchinson Cancer Research Center)

• Fei Gao, Fred Hutchinson Cancer Research Center
• Alex Luedtke, Department of Statistics, University of Washington
• Sheila Kansiime, LSHTM, Medical Research Council, Uganda Virus Research Institute,
• Dave Glidden, UCSF
• Peter Gilbert, Fred Hutchinson Cancer Research Center

The main goal of the panel discussion is to explore novel scientific approaches for establishing efficacy of new biologics in a future where all trial participants have access to effective prevention and to identify gaps in knowledge or barriers to use of the statistical methods.

Session 3B: Community Engagement and Involvement in HIV Vaccine Prevention Clinical Research  

Community engagement and involvement in HIV vaccine prevention clinical research

Chair: Matthew Rose (HealthGap, Director US Policy and Advocacy)

• Nandi Luthuli (AVAC)
• Jim PIckett (AIDS Foundation Chicago)
• Rafael Gonzalez (HVTN)
• Kagisho Baepanye (HVTN)
• Dazon Dixon Diallo (SisterLove)

The main goal of this panel discussion is to address current trials across product modalities (e.g., vaccines, oral and injectable PrEP), community needs and considerations of current trials, then move into a broader discussion on community considerations of future trial designs, including acceptability, access, and meaningful engagement.

PrEPVacc trial statistical analysis plan

Sheila Kansiime, Ph.D.

LSHTM, Medical Research Council / Uganda Virus Research Institute, Uganda.

A brief overview of the PrEPvacc trial followed by a detailed presentation of the statistical analysis plan and some of its novel aspects.

A Bayesian Framework for Inferring Background HIV Incidence: An Application Using Tenofovir Drug Levels.

David Glidden, Ph.D.
University of California San Francisco, San Francisco, USA.

How to use Tenofovir pharmacology to help reconstruct an hypothetical placebo arm.

Estimation of Dapivirine vaginal ring efficacy in the HOPE trial

Alex Luedtke, Ph.D.

University of Washington, USA.

Evaluating vaccine efficacy of a candidate HIV vaccine vs. counterfactual placebo:
immune Mediator Approach

Peter Gilbert, Ph.D.
Fred Hutchinson Cancer Research Center, University of Washington, USA.

Design for active-arm trial with counterfactual placebo Incidence based on Recency test

Fei Gao, Ph.D.
Fred Hutchinson Cancer Research Center, University of Washington, USA.

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