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VaxGen Officials Report Increased Statistical Confidence in Human Trial Results of HIV Vaccine
VaxGen officials, who are preparing to release by early March results of late-stage human trials of an experimental HIV vaccine, called AIDSVAX, yesterday said that higher-than-expected patient retention rates and increased HIV incidence rates will lead to higher confidence levels, Dow Jones reports. Of the 5,400 people in the study -- which is taking place in the United States, Canada, the Netherlands and Puerto Rico -- 95% participated in the entire trial, 10% more than expected, and the incidence rate of HIV has risen from 1.5% four years ago to 3%, Dow Jones reports. Lance Ignon, a VaxGen spokesperson, said these figures are "good news from a bio-statistical standpoint," but they are not a guarantee of the vaccine's effectiveness or of FDA approval (Bennett, Dow Jones, 1/8). Researchers are trying to determine whether the vaccine candidate is effective in protecting against HIV infection, and trial results showing the effectiveness of the vaccine will be "certain to generate enormous attention." Half of the participants in the trial -- 5,100 homosexual men and 300 women with multiple sex partners -- received the vaccine, and half received a placebo, which was injected by doctors in "hundreds" of locations. In addition, VaxGen later this year is expected to announce the results of a trial of the vaccine that included 2,400 injection drug users in Thailand. The FDA has already fast-tracked the review process for AIDSVAX (Kaiser Daily HIV/AIDS Report, 12/23/02). The goal of the trial is prevention of HIV in 60% of patients, and company officials have said in the past that gaining federal approval could depend on meeting a 30% threshold, Reuters reports. However, VaxGen CEO Lance Gordon yesterday said that if the trial shows a 20% effectiveness rate, the company "could certainly proceed" with an FDA application (Reuters, 1/8).
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