Thai HIV vax trial controversy continues to brew

The post mortems on the Thai HIV vaccine trial continue to pour in following the revelation in the New York Times that AIDS researchers briefed on the results found out that a separate--and initially undisclosed--analysis of the trial data came up with a more modest efficacy rate. While scientists grabbed headlines the world over with their conclusion that a new vaccine was 31 percent effective in preventing HIV, the secondary analysis concluded that 26 percent might be a more accurate number.

"The bottom line is that this makes what was already a borderline result seem even more marginal," Paul E. Sax, MD, clinical director of the HIV Program and Division of Infectious Diseases at Brigham and Women's Hospital, told Medscape HIV/AIDS.

Anthony Fauci, director of the National Institute of Health's National Institute of Allergy and Infectious Diseases, was left to defend the way the trial numbers--the first hard sign that vaccine developers were on the right track toward quelling AIDS--were reported. Their original analysis used "gold standard" techniques, he said, and including other analyses "would have confused everybody." Allegations that more accurate data were hidden? "Absurd."

Sax, though, seems anything but confused. "In short, two additional analyses (modified per protocol and per protocol) do not show a statistically significant protective effect," he noted. "In other words, the study subjects who followed the protocol most closely had less protection from the vaccine strategy." 

- here's the story from Medscape

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