DESIGN APPROACHES FOR CURRENT AND FUTURE HIV PREVENTION EFFICACY TRIALS

VIRTUAL WORKSHOP SERIES
OCTOBER 2020 to MAY 2021

#HIVPxTrialDesign

Session 2: 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 second session of the virtual workshop aims to reflect on future trial designs for ARV-based prevention strategies, HIV vaccines and monoclonal antibodies. This session is supported by a further six bite-size presentations and three panel discussions of the current scientific approaches for establishing efficacy of vaccines in the broader context or Pre-Exposure Prophylaxis (PrEP).

Workshop Home Session 1 Session 3

PANEL DISCUSSION 2A – Friday 06 November 2020.

Future Design Approaches For Trials Of Antiretroviral-Based Prevention Strategies

PANEL DISCUSSION 2B – Wednesday 18 November 2020.

Future Design Approaches for HIV Vaccine Efficacy Trials

PANEL DISCUSSION 2C – Thursday 8 April 2021.

Research pathway for the use of monoclonal antibodies in HIV prevention.

VRC01 antibody prevention of HIV

Lawrence Corey, M.D.
Fred Hutchinson Cancer Research Center, USA.

Antibody Mediated Prevention: Where to from here?

A Research for Prevention // Virtual event.

Satellite timeline

  • 00:50 John Mascola: History of VRC01.
  • 07:11 Sri Edupuganti: Profile and experiences of participants in HVTN704/HPTN085.
  • 12:30 Nyaradzo M. Mgodi: Profile and experiences of participants in HVTN703/HPTN081.
  • 18:00 Peter Gilbert: Study design of AMP.
  • 29:28 Lynn Morris: The relationship between serum neutralisation titres and HIV acquisition in the AMP trials.
  • 41:15 Lawrence Corey: What do these data mean for the future of Antibody Mediated Prevention?
  • 49:50 Panel discussion: Antibody Mediated Prevention; Where to from here?
PresentationPresenter
Inferring HIV incidence using incidence of other STIsJared Baeten, M.D., Ph.D. – University of Washington, Seattle, USA.
Cross-sectional HIV incidence estimation using recent infection assays and algorithms – A statistical perspectiveEduard Grebe, Ph.D – Vitalant Research Institute, San Francisco, USA.
Cross-sectional incidence assays to infer population incidence – Clinical trial perspectiveSinéad Delany-Moretlwe, MBBCh Ph.D. DTM&H – Wits RHI, South Africa.
Using of a surrogate endpoint in licensure of pneumococcal vaccinesDavid Radley, M.Sc. – Pfizer Inc. – New York, USA.

A case study in using extra-trial data to infer placebo incidenceMia Moore, Ph.D. – Fred Hutchinson Cancer Research Center, Seattle, USA.
Future directions for more granular estimation of HIV incidenceJeffrey W. Eaton, Ph.D. – Imperial College London, UK.

Inferring HIV incidence using incidence of other STIs (S2-01)

Jared Baeten, M.D., Ph.D.
University of Washington, Seattle, USA.

Cross-sectional incidence assays to infer population incidence (S2-02)

Eduard Grebe, Ph.D.
Vitalant Research Institute, San Francisco, USA.

Cross-sectional incidence assays to infer population incidence​(S2-03)

Sinéad Delany –Moretwe, MBBCh, Ph.D., DTM&H
Wits RHI, South Africa.

Using of a surrogate endpoint in licensure of pneumococcal vaccines (S2-04)

David Radley, M.Sc.
Pfizer Inc., USA.

A case study in using extra-trial data to infer placebo incidence (S2-05)

Mia Moore, Ph.D.
Fred Hutchinson Cancer Research Center, Seattle, USA.

Incorporation of trial incidence data into model estimate (S2-06)

Jeffrey W. Eaton, Ph.D.
Imperial College London, London, UK.

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