Vaccine Fails to Show Efficacy: Data from subgroup analysis is intriguing But drawing conclusions would raise false hopes

NEW YORK - The AIDS Vaccine Advocacy Coalition (AVAC) today expressed disappointment that the first efficacy trial of an AIDS vaccine failed to show protection in the study population. The trial was of the vaccine candidate AIDSVAX that is made by VaxGen.

"Of course it's unfortunate that AIDSVAX did not demonstrate efficacy in the study population of over 5000 men who have sex with men and over 300 women at risk of HIV infection," said Chris Collins, Executive Director of AVAC. "But this trial should not be characterized as a failed effort. More human trials of better candidates in several countries will likely be necessary to identify an AIDS vaccine."

"The AIDSVAX results did provide surprising data in the sub-population of African American trial participants," Collins said. "But the trial simply was not designed to demonstrate efficacy in this subgroup and the numbers of participants in this group are too small to draw any conclusions about the vaccine's effects in this subpopulation."

"The African American community has been devastated by AIDS, and finding a vaccine that could protect African Americans would be truly outstanding," Collins said. "But given the overall finding, at this stage in the data analysis, it would be hazardous to jump to conclusions about what the AIDSVAX data mean for this subgroup. Such premature conclusions run the risk of raising false hopes in a world desperate for an AIDS vaccine. Further examination, and perhaps further trials, are necessary before conclusions can be drawn."

There are over 20 other AIDS vaccine candidates in or nearing clinical trials and several are considered more promising than AIDSVAX. These candidate vaccines use multiple different approaches to protect from HIV. "AIDS vaccine research is a long term effort," Collins said. "The North American AIDSVAX trial has been one important step in that effort."

AVAC is a community and consumer based organization dedicated to accelerating the ethical development and global delivery of AIDS vaccines. AVAC provides education, analysis and advocacy to advance AIDS vaccine research. The organization does not accept funding from government or the pharmaceutical industry. AVAC is supported by the Bill & Melinda Gates Foundation, the Ford Foundation, the International AIDS Vaccine Initiative, Until There's a Cure Foundation, Gill Foundation, Broadway Cares/Equity Fights and many generous AVAC Members.