Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
Bay Area Reporter - September 27, 2007
Bob Roehr
[An article with local reaction was posted on the Bay Area Reporter's Web site last Friday. See: http://ww2.aegis.org/news/bar/2007/BR070907.html]
The vaccine neither reduced the number of persons who became infected, nor eased the course of disease of those who became infected, according to a scheduled interim analysis. It was conducted by a Data Safety Monitoring Board, an independent panel of experts that had access to all of the data that even the leaders of the trial could not see under the rules of the trial.
In fact, those who received at least one dose of the vaccine were slightly more likely to become infected with HIV than were those who received a placebo. But the numbers were small, 24 of 744 and 21 of 762, respectively. Among volunteers who received two doses of the vaccine, 19 of 672 became infected, while only 11 of 691 in the placebo arm became infected.
The findings did not reach what is called statistical significance; the differences might possibly be explained by randomness, rather than be a product of the vaccine used.
However, what is clear is that the vaccine provided no protection, and so the STEP trial and another more recently initiated trial were stopped. No more of the vaccine will be administered while a full and complete analysis of the data takes place. Meanwhile, study participants are asked to continue with their follow-up visits so that they can be monitored and additional data gathered.
Peter S. Kim, Ph.D., president of Merck Research Laboratories, expressed disappointment with news of the interim analysis. "Sadly, developing an effective AIDS vaccine remains one of the most challenging tasks facing modern medicine."
NIAID Director Anthony Fauci has often explained, "With other viruses, 90-plus percent [of those who become infected] can clear the virus, even smallpox and polio." The trouble with HIV is that "the natural immune response is inadequate." He said that with an HIV vaccine, researchers are trying to create what nature has not been able to create.
"These data are certainly not the ones that we had hoped for," said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition. "However, it must be seen for what it is; the failure of a product to show efficacy in a specific trial ... It is in no way the end of the search for an AIDS vaccine."
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