Behind the Rising Doubts About Hailed AIDS Vaccine

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HIV burgeoning on a lymphocyte

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Fauci acknowledges that the vaccine's effect is small, but believes that it's an important first step toward understanding how the body fights off HIV. "It's barely significant, yes," he says. "But it's interesting in that it opens up a door for us to be able to pursue more research." Although the number of volunteers who were protected were few, they are still the first who may have been protected at all by an AIDS vaccine and are therefore considered a valuable starting point.

Still, the manner in which the trial results were released raised suspicions among some in the AIDS-research community. Scientific results are generally vetted in a two-step process: first, they are published in a peer-reviewed journal, which means a panel of scientists has reviewed and evaluated the validity of the study's methods and the authors' conclusions before publication; once published, other research groups repeat or analyze the data in more depth to further ensure that they are legitimate. The results of the AIDS-vaccine trial did not benefit from either leg of this process. The investigators chose instead to announce the results in a press conference in Thailand, at the request of the Thai government, which wanted to inform its citizens of the positive findings as soon as possible. A U.S. press conference, including the U.S. Army researchers and Fauci, was held several hours later, with a promise to follow up with more detailed data in a presentation at the annual AIDS Vaccine Conference in Paris on Oct. 20.

To confound matters further, after the Thai press conference, a select number of scientists received confidential data on the study. After reviewing the numbers, some of them discussed their concerns over the discordant statistics with journalists at Science magazine's Science Insider blog and the Wall Street Journal.

From the outset, the vaccine strategy used in the NIH and U.S. Army study — giving two older vaccines in succession — has been controversial. In previous trials, each vaccine had failed to provide any protection against HIV, and in September 2004 a group of adamant scientists wrote a letter to Science arguing that the National Institute of Allergy and Infectious Diseases should not to continue with the trial. "We seriously question whether it is sensible now to conduct a ... trial that, in our opinion, is no more likely to generate a meaningful level of protection against infection or disease," they wrote.

The scientists' skepticism about the strategy seems to be at least partially justified. But even so, at least one of the 22 authors of that Science letter is waiting for the release of the full set of data before acknowledging complete vindication. "I think I will wait until after the Paris meeting next week to see more of the data before making any comments," wrote Dennis Burton, an immunologist at Scripps Research Institute, in an e-mail response to a request for his reaction.

While unfortunate, Fauci says the circumstances surrounding the release of the data should not detract from the potential benefit the results may yet extend to AIDS-vaccine research. The trial was never intended to serve as a demonstration of effectiveness to license a new vaccine, he says. As such, it was a proof-of-concept study that showed it is indeed possible to generate an immune response against HIV — even if only a small one.

Correction: The original version of this article misstated that some AIDS researchers received confidential data prior to the Thai press conference in September; they received the data after. The article also misstated that these researchers published their concerns on the website of the journal Science; in fact they gave interviews to a Science reporter. Clarification: The original article did not elucidate the particular conditions under which researchers would analyze a smaller subset of clinical trial data, rather than the complete, original set; those details have been incorporated in the text.

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