July 17, 2008
NEW YORK, July 17, 2008 —Today, the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) announced that it will not go ahead with the proposed Phase IIb AIDS vaccine trial known as PAVE 100. The announcement followed the failure last September of an AIDS vaccine candidate with some similarities to the PAVE 100 candidate in a Phase IIb trial known as STEP.
Responding to the announcement, International AIDS Vaccine Initiative President and CEO Seth Berkley said, “The NIAID decision is a bold decision that bears in mind the lessons offered by the STEP study. That is the way good scientific endeavors work. And that is not the end of it. Because the PAVE vaccine candidate is different from the STEP candidate, we can still learn something from testing the PAVE candidate in humans. It’s just not necessary to do so in a trial involving thousands, as called for in the PAVE 100 design. So NIAID is considering a smaller, more focused trial. In the wake of the STEP trial, these kinds of smaller studies, such as the Screening Test of Concept trial proposed by IAVI, should become the norm, to test for a sign of promise before proceeding to large efficacy trials.
“The decision by NIAID does not reflect paralysis in the AIDS vaccine field, or a lack of direction forward. In fact, it reflects the opposite. It reflects the dynamic learning that is the scientific process, that is pharmaceutical product development. The decision reflects leadership on the part of NIAID.
“The AIDS vaccine field does not suffer from a lack of ideas about how to move forward. Yes, significant progress remains to be accomplished before an effective, preventive vaccine is within our grasp. But researchers are working apace on such projects as solving the HIV neutralizing antibody problem, determining how elite controllers remain disease-free for decades, determining how live-attenuated SIV vaccines work, developing replicating vectors for use in AIDS vaccines, developing AIDS vaccine candidates that elicit mucosal immunity, and exploring the use of gene therapy for AIDS vaccines. There’s a lot of work going on and a lot more that needs to get done. We’re not at our destination, but we know the paths to follow.”