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AIDS study announcement questioned

United Press International - October 10, 2009


The encouraging results of an AIDS vaccine trial announced by the U.S. Army and Thailand may have been a fluke, a scientist says.

The Army, the Thai government and the U.S. National Institutes of Health, which helped finance the three-year, $105 million study, announced last month the results indicated they had found the first vaccine that provided some protection against human immunodeficiency virus. But an Army scientist involved in the project said a second analysis of data showed the results weren't statistically significant, The Wall Street Journal reported Saturday.

Scientist Jerome Kim told the newspaper that officials were aware of the second analysis when it made the announcement but went ahead anyway. The newspaper said the second analysis, which is considered a vital component of any vaccine study, indicated the results could have been due to chance.

The initial results indicated the vaccine reduced by the chance of infection with HIV, the AIDS-causing virus, by 31 percent, but a follow-up "per protocol" analysis showed there is a 16 percent chance the study results were a fluke, which, the newspaper said, is a far greater probability than is considered statistically acceptable.

Questions have reportedly been raised by the incomplete disclosure. Among them is the National Institute of Allergy and Infectious Diseases, the part of the NIH that oversees AIDS research, rushed out a positive spin on what may have been an expensive, inconclusive effort.

NIAID Director Anthony Fauci declined to comment to the Journal.


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