The AIDS Vaccine Research Subcommittee (AVRS) met in public session on May 30, 2008 at the Bethesda North Marriott Hotel and Conference Center in Bethesda, MD.
This regular meeting of the AVRS focused on PAVE 100A. Presentations elucidated the findings from the STEP study, described the design and rationale behind the PAVE study and reflected the community’s perspective. The PAVE 100A team emphasized that the STEP study should be interpreted as a failure of a product rather than a failure of a concept, and delineated the similarities and differences between the VRC vaccine and the vaccine used in STEP. The VRC vaccine that would be used in PAVE 100A has a different profile in non-human primate studies and the targeted population for PAVE 100A should reduce safety risks.
The questions posed to the AVRS:
The AVRS was impressed by the PAVE 100 team’s responsiveness to the AVRS recommendations of December 12, 2007 and made the following observations:
Community members recognized the challenges of implementing PAVE 100A given the proximity of the STEP trial; and while there was a general perception that the trial could be successfully implemented, it was recognized that if the trial goes forward considerable effort must be made to engage and educate communities as to the rationale and importance of the protocol to the field.
Input from two members of the public was obtained. The first argued that given the limited differences between the Merck and VRC vaccines and the limited chances for a successful outcome that the PAVE 100A trial should not go forward. The second also argued against the trial with concerns about the limited data for differences, and the potential negative impact of an unsuccessful trial.
Some committee members felt that the comparison of the Merck and VRC immunogenicity studies indicated that there is no reason to hypothesize that the VRC vaccine will have any chance of efficacy, and that the modified PAVE 100 A trial should not go forward.
In terms of the 3 questions posed to the AVRS one member proposed the following:
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Last Updated June 27, 2011