Clear black and white? said VaxGen's vaccine helped prevent HIV infection in participants in non-Caucasian tests.
The data from the first large-scale warming, the test of the real world of a vaccine against AIDS show that, like most researchers had long predicted, it failed to prevent HIV infection. But in a press conference this morning Webcast, the vaccine manufacturer - VaxGen of Brisbane, California - argued that it was to protect 67% of non-Caucasians in the study. Although many AIDS researchers quickly made reservations and even deep skepticism, the scientists said VaxGen they have compelling statistics and immunological data supporting the strange conclusion.
Two thirds of the 5,000 participants in the 4-year study was the VaxGen vaccine that contains a genetically engineered version of the HIV surface protein, while others received placebo shots. The analysis showed that HIV has infected 5.7% of the vaccine group and 5.8% of those who received placebo. "Efficacy has not taken place," firmly concludes Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who all but abandoned the vaccine in 1994, when the first results of human studies indicated that it probably would not work
But debates about the meaning of the subgroup analyzes. - which hinge on the vaccine or placebo status of the 13 blacks who were infected (see chart) - have already begun to roil AIDS researchers First, as noted Fauci, the subgroup analyzes are "very interesting and provocative." - if the data prove real. "I would have really hardcore statisticians pore over the data and let us know what that means," he said.
Others asked how hard the company presented data from the study, which took place in the United States, Canada, Puerto Rico and the Netherlands. "I do not think the subgroup analysis is robust enough to draw conclusions whatsoever," said one of the most vocal critics of the vaccine, HIV antibody expert John Moore of the Medical University of Cornell in New York City. Moore takes particular exception to the assertion that VaxGen vaccine triggered higher levels of antibodies to HIV among blacks, who putative explain why the vaccine worked better in this subgroup. "I have never seen any analysis that blacks have antibodies to HIV than whites, "says Moore.
VaxGen currently has a second efficacy trial of its vaccine against AIDS in courses in Thailand. the company plans to reveal the results of this study in the fall.
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