HIV-1 vaccines and adaptive trial designs

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HIV-1 vaccines and adaptive trial designs presented by Dr James Kublin, Executive Director, HVTN, Fred Hutchinson Cancer Research Center.

The presentation details the following:

Objectives of the Research Trial Design

· Primary objective: For each vaccine regimen, to evaluate VE against HIV infection within 18 months of randomization [i.e., VE(0-18)]

· Secondary objectives:

o To evaluate durability of VE out to 36 months for each regimen showing reliable evidence for positive VE(0-18)

o To expeditiously and rigorously evaluate immune correlates protection if any of the vaccine regimens show reliable evidence for VE(0-18) > 0%

o To compare VE among the vaccine regimens

· An adaptive 2-stage design for each vaccine regimen:

o Stage 1 evaluates VE(0-18)

o Stage 2 evaluates longer-term VE(t), and occurs if and only if the trial provides reliable evidence for VE(0-18) > 0%

The Adaptations Follow FDA Guidance Principles

· Adaptations can be done safely without sacrificing design integrity if:

o Planned: Adaptation triggered by pre-specified deterministic rules [may depend on VE]

o Independent of treatment: Adaptation unplanned, but is based on treatment-blinded data

· The developed designs are in the safe zone, adhering to the FDA guidance document Adaptive Design Clinical Trials for Drugsand Biologics February 2010

And more…

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