AVAC comments on NIAID decision not to move forward with PAVE 100 Trial

The AIDS Vaccine Advocacy Coalition (AVAC) today urged Dr. Anthony Fauci and the U.S. National Institute of Allergy and Infectious Diseases (NIAID) to act swiftly to clarify the path ahead suggested by the announcement that NIAID would not go forward with the proposed PAVE 100 AIDS vaccine trial but would, instead, consider a smaller trial of the same candidate. AVAC also calls on leaders in the field to make clear commitments of financing, leadership and scientific exploration to further the search for an AIDS vaccine. The decision not to move forward comes just over one month after a meeting of the AIDS Vaccine Research Subcommittee at which the majority of participants voiced support for the scientific premise and the trial design of the proposed PAVE 100 trial. At that meeting, AVAC also voiced cautious support for the trial going forward, while stressing that there was no substitute for extended community education and consultation to ensure that diverse groups of men who have sex with men, who would be asked to participate in the study, would have a clear and decisive role in determining the acceptability of the study.

"In deciding not to go ahead with PAVE 100, Dr. Fauci and NIAID have likely considered other fiscal and feasibility considerations beyond these scientific recommendations," said AVAC Executive Director Mitchell Warren. "The reality of science is that these issues also carry great weight. However, after nearly a year of public hand-wringing and unproductive public attacks on the entire search for an AIDS vaccine, it is essential that this decision not be viewed as a vote of no-confidence for the overall endeavor."

"At AVAC we supported the scientific premise of the trial and believed that it was being designed in such a way that participants' safety would be protected to the fullest extent possible," Warren said.

"While the consultative process around the trial had insufficient community input, it did feature frank and challenging debate from a diverse, independent group of scientific leaders in the field. Within this group, the majority felt that important information could be gleaned from testing the VRC strategy that would have been used in PAVE 100. Many also voiced some concern that scaling back the trial design could lead to results that might be difficult to interpret or less useful than they could be. It will be critical to pursue these issues further and to closely consider the appropriate design for a scaled-back study.

"NIAID has stated that it will consider a proposal for such a trial. This new proposal must be subject to an even higher level of consultation and discussion that has taken place to date, and there must be adequate investment by NIAID in this process.

"This will not be the last time that the scientific community is asked to weigh in on whether or not an AIDS vaccine trial should go forward. This most recent development should be a guide to NIAID and the entire field on how to improve the decision-making process for the future. At a minimum, such a process must include more rigorous and legitimate community input," Warren said.

In the debates and discussions that have led up to this decision, many members of the scientific community have, along with AVAC, affirmed the value of clinical research as a vital component of the search for an AIDS vaccine. Although this one trial will not happen, AIDS vaccine research involving humans can, will and must continue.

"This decision in no way signals an end to the involvement of volunteers in the search for a safe and effective AIDS vaccine," Warren added. "AVAC believes that the field must redouble efforts to develop and implement a broad scientific agenda that includes basic science, preclinical work, and human trials of promising HIV vaccine candidates."

Many communities around the world, including here in the U.S., are ravaged by HIV/AIDS. AVAC will continue to work with researchers, communities, policy makers and others to advocate for the development and delivery of a comprehensive response to AIDS that includes dramatically expanded access to existing treatment and prevention along with research to find new HIV prevention and treatment options.

Source: AIDS Vaccine Advocacy Coalition (AVAC)