VaxGen’s announcement of AIDSVAX results causes controversy

By Advocate.com Editors

Originally published on Advocate.com February 26 2003 12:00 AM ET

VaxGen's announcement on Monday of results from the company's Phase III clinical trial of AIDSVAX, the first HIV vaccine to make it to human trials, has caused some controversy among AIDS researchers and activists who are concerned over the company's suggestion that the vaccine may be useful for some minority groups. Although VaxGen officials said the vaccine was ineffective in preventing HIV infections in the general population, they added that subset data for blacks and Asians showed better results. Only four of the 203 black study subjects who received the vaccine tested positive for HIV antibodies during the course of the study, compared with nine of 111 blacks who received a placebo. Of 54 Asians who received the vaccine, only two tested positive, compared with two of 20 Asians who received placebos. Based on these findings, VaxGen officials said they planned to continue developing AIDSVAX for possible use in these minority communities.

But some AIDS activists and researchers say VaxGen's suggestion that AIDSVAX might be useful in preventing HIV infections among blacks and Asians is premature and a result of the company trying too hard to put a positive spin on otherwise disappointing trial data. "My sense is that they're way out in front of the data," Gregg Gonsalves, director of treatment and prevention advocacy at Gay Men's Health Crisis in New York City, told The Wall Street Journal. John Moore of New York's Weill Cornell Medical Center told the Los Angeles Times that there is "no biological reason based on how the vaccine works that race would make a difference." He suggested VaxGen "played the race card...because [the company] had to show some results to its public investors."

The AIDS Vaccine Advocacy Coalition, San Francisco's Project Inform, and the Treatment Action Group released a joint statement calling VaxGen's announcement misleading. Martin Delaney, founding director of Project Inform, added, "The company is claiming that this vaccine works better in African-Americans and other non-Hispanic racial subgroups based on a difference of five people. This is at best premature and irresponsible data reporting. It is highly misleading and disingenuous to communities who have a stake in these findings. It would do a great deal of harm to stir up hopes for selected groups over a vaccine that has been proven ineffective overall."

But not all AIDS experts were upset over VaxGen's announcement. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told The New York Times that his agency welcomed the subset data presented by VaxGen and that NIAID plans to conduct laboratory tests on blood samples from trial participants to uncover any immune or genetic factors that could explain the results. He also called the results "provocative enough to give very good reason to consider funding a larger study of this or other AIDS vaccines among minorities."