NIAID Decides Not to Conduct PAVE 100

On Thursday, July 17^th, The National Institute of Allergy and Infectious Disease (NIAID) announced that it would not move ahead with the PAVE 100 HIV vaccine study. The trial, proposed in January 2007, was originally designed to study the efficacy of a vaccine candidate developed by NIAID’s Vaccine Research Center (VRC) in 8,500 volunteers in the United States, South America, the Caribbean and Eastern and Southern Africa. NIAID immediately postponed the trial when the Merck ® STEP study, which tested a similar concept, was halted due to futility and possible increased risk of infection.

After careful reevaluation, PAVE researchers proposed a modified trial design in May of 2008 based on the analyses of the STEP study results. The new trial would have been smaller in scope than the original, taking extra safety precautions while studying safety, tolerability, and immune response.

NIAID has been considering the newly proposed PAVE 100 trial for several months. Dr. Anthony Fauci, Director of NIAID, solicited and considered broad input from the scientific and HIV advocacy community before making the decision not to conduct the PAVE 100 trial. But, NIAID did announce that it would entertain proposals for an alternative study.

In an official press statement, NIAID stated, “Based on the available scientific information, NIAID has decided that the VRC vaccine regimen did not warrant a trial of this size and scope and that PAVE 100 will not proceed. However, NIAID will entertain a smaller, more focused clinical trial designed to answer one important question: Does the product have a significant effect on HIV viral load?”

Click here to read NIAID’s statement on the PAVE 100 trial.

Click here to read the AIDS Vaccine Advocacy Coalition’s (AVAC) statement on the PAVE 100 trial decision

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