Word: trialing
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Dates: during 2000-2009
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Detailed simultaneously on Tuesday at the Paris meeting and in a paper in the New England Journal of Medicine, the U.S. government-sponsored trial (both the National Institute of Allergy and Infectious Diseases and the U.S. Army provided funding) involved about 16,400 Thai volunteers. Half were given six injections comprising two AIDS vaccines, neither of which had proved effective in previous studies; the other half of the study group was given a placebo. (Read "The Flip Side of Placebos: The Nocebo Effect...
...approach was 31% effective in preventing HIV infection: 51 of the roughly 8,200 people who had been inoculated eventually acquired HIV, compared with 74 people in the placebo group. The analysis that resulted in the 31% figure, however, included study participants who became infected with HIV before the trial concluded and did not complete the entire vaccination schedule; it also factored out participants who were discovered to have been HIV-positive before the trial began. At a press conference at the Paris meeting, Dr. Nelson L. Michael, a virologist with the U.S. Military HIV Research Program, which helped...
Perhaps, but the release of the trial's full data has not quelled the early criticism that bubbled up around it. Some researchers contend that the second and third analyses of the data - including the "per protocol" analysis, which included only the 12,450 volunteers who received all six vaccine or placebo injections and completed the trial and the "intent to treat" analysis, which included everyone except the previously HIV-infected participants - show that the results are not statistically significant. Both analyses found the vaccine to be just 26% effective - that figure is empirically low, but further, the analyses relegate...
Still, after more than 25 years of virtually futile AIDS-vaccine research, the investigators involved in the Thai trial believe that their findings, while admittedly "modest," offer unprecedented leads to follow. "To quote from our recent history, this is a 'Yes we can' moment," Michael says. "It is not a public health breakthrough, [and] there is not a vaccine around the corner. But the door has finally been cracked open...
...manner in which the study was presented to the public - is secondary to what the research brings to the battle against HIV. "Let's not get hung up on tangential concerns, and stay focused on everyone's main priority: working our way toward getting a vaccine," Bernstein says. "This trial isn't the big bang. It isn't perfect, and [it] has only provided points of information that must be examined, pursued and - yes - hotly debated. But that's what science is about, and we've got more now to go on than we did before...