Newsday - February 24, 2003
Laurie Garrett, Staff Writer

Overall, AIDSVax -- the first anti-HIV vaccine to complete Phase III clinical trials -- offered no protection to the volunteers who received it. After three years, the results were statistically identical: 5.8 percent of the placebo group became infected with HIV, compared to 5.7 percent of those receiving the vaccine.

Five-thousand-nine volunteers completed the trial; 4,185 were white. Most were gay men deemed at risk due to their lifestyles. Volunteers were from the United States, Canada, Puerto Rico and Europe.

"We were disappointed that the vaccine did not produce a reduction in infections in all population groups," VaxGen CEO Lance Gordon said yesterday in a briefing. "The study did not show a statistically significant reduction of HIV infection within the study population as a whole, which was the primary endpoint of the trial."

However, Gordon said, analysis of racial subgroups indicated that blacks and, to a lesser degree, Asians may have been better protected by the vaccine. Additionally, antibodies against HIV were found in their blood.

As a result, Gordon said, VaxGen will seek a license from the U.S. Food and Drug Administration for manufacture and sale of the vaccine, and will turn to the World Health Organization, PanAmerican Health Organization and Gates Foundation for funding for distribution.

"I think that is, to say the least, premature," Dr. Peter Piot, director of the United Nations AIDS Programme, said in an telephone interview from Geneva. "We will not support raising funds for distribution of this vaccine." WHO and UNAIDS might consider the vaccine's use, Piot said, if another VaxGen trial now under way in Thailand yields better overall results. Gordon indicated those results will be released later this year.

In an interview, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, labeled the VaxGen findings of racial differences "provocative," but said "one needs to go over every aspect of the numbers." And Dr. Seth Berkely, head of the International AIDS Vaccine Initiative, expressed disappointment at the overall results and also said "it is difficult to draw conclusions about what this [the racial results] means, given that the number of blacks in the study was so small."

VaxGen reported 13 total infections among the 314 black volunteers: 4 in the vaccine group and 9 in the placebo group.

"If there really was a difference among blacks, it then takes a giant leap to go from African Americans to blacks in Africa" in concluding AIDSVax might be wisely used in Africa, Berkely said. "It would be very difficult to determine the biological plausibility there."

"The numbers are small" for racial subgroup analysis, said Dr. Michael Para of Ohio State School of Medicine, who led the statistical analysis conducted for VaxGen. Of the Asian volunteers, two who got the placebo became HIV infected, he said, as did two of the 53 who got the vaccine.

Similarly, among black volunteers, 9 of 111 receiving placebo became infected, compared to 4 of 203 who got the vaccine.

"You're right, the numbers are small," Para said at the VaxGen briefing when asked if those numbers are sufficient to presume the vaccine worked for blacks. "You're starting to talk about a few infections here and there." Among whites and Hispanics, 5.4 percent of the in the placebo group of 1,508 became HIV infected, compared to 6 percent of the 3,003 vaccine recipients.

Those numbers, taken alone, mean there's "actually an increase [in infection] in the whites and Hispanics [receiving the vaccine], which is being disguised by the racial subgroup analysis," immunologist John Moore of Cornell Weill Medical Center in Manhattan, said in an interview.

Dr. Bette Korber, a noted bio-mathematician at Los Alamos National Laboratory, said in an interview, "I would interpret their results among minorities as possibly interesting trends in the data, but not statistically significant -- at best, as a hypothesis forming stage, not as a basis for drawing conclusions or declaring significance."

Racial analysis aside, various leaders said AIDSVax is simply not the much-sought solution to the HIV pandemic. "Continued HIV vaccine research remains an urgent global need," Dr. Gro Harlem Brundtland, Director-General of WHO, said in a statement. "We will need many more trials to develop effective HIV vaccines, particularly against the most prevalent HIV sub-types, which are having a devastating impact on populations in sub-Saharan Africa."

IAVI's Berkely noted several other vaccines have reached the Phase II stage of clinical trials, and more are in earlier stages of development. At least one is expected to enter Phase III trials this year in Thailand, with results available four years later, Berkely said.
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