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The results: New infections occurred in 51 of the 8,197 given vaccine and in 74 of the 8,198 who received dummy shots. That worked out to a 31 percent lower risk of infection for the vaccine group. Two of the infected participants who received the placebo died.
The vaccine had no effect on levels of HIV in the blood for those who did become infected. That had been another goal of the study -- seeing whether the vaccine could limit damage to the immune system and help keep infected people from developing full-blown AIDS.
That result is "one of the most important and intriguing findings of this trial," Fauci said. It suggests that the signs scientists have been using to gauge whether a vaccine was actually giving protection may not be valid.
"It is conceivable that we haven't even identified yet" what really shows immunity, which is both "important and humbling" after decades of vaccine research, Fauci said.
Details of the $105 million study will be given at a vaccine conference in Paris in October.
This is the third big vaccine trial since 1983, when HIV was identified as the cause of AIDS. In 2007, Merck & Co. stopped a study of its experimental vaccine after seeing it did not prevent HIV infection. Later analysis suggested the vaccine might even raise the risk of infection in certain men. The vaccine itself did not cause infection.
In 2003, AIDSVAX flunked two large trials -- the first late-stage tests of any AIDS vaccine at the time.
It is unclear whether vaccine makers will seek to license the two-vaccine combo in Thailand. Before the trial began, the U.S. Food and Drug Administration said other studies would be needed before the vaccine could be considered for U.S. licensing.
"This is a world first which proves that vaccine development is possible," said Dr. Supachai Rerks-Ngarm, the Thai Health Ministry official who oversaw the trial. "But this is not to the level where we can license or manufacture the vaccine yet."
Mass-producing the vaccine, plus how to proceed with future studies, will be discussed among the governments, study sponsors and companies involved in the trial, Kim said. Scientists want to know how long protection will last, whether booster shots will be needed, and whether the vaccine helps prevent infection in gay men and injection drug users, since it was tested mostly in heterosexuals in the Thai trial.
The study was done in Thailand because U.S. Army scientists did pivotal research in that country when the AIDS epidemic emerged there, isolating virus strains and providing genetic information on them to vaccine makers. The Thai government also strongly supported the idea of doing the study.
On the Net:
Vaccine coalition: http://www.avac.org/
Government AIDS info:
Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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