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Warning Is Sent to AIDS Vaccine Volunteers

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The Merck vaccine trials took place in 15 cities in the United States, including Boston, Los Angeles and New York, and three in Canada. There also were sites in Peru, Brazil, Australia, Haiti, the Dominican Republic and Jamaica. Those trials began in December 2004 and included 3,000 participants, mostly gay men.

In South Africa -- where an estimated 5.5 million people are infected with HIV, more than in any other country -- the study used the same vaccine but was administered separately. The trial here started later, with the first injections this year, and had its own ethics oversight board. Most of the subjects were heterosexual.

The ethics oversight board in the United States, which monitored the trial everywhere but in South Africa, has not decided whether to tell participants if they received the placebo or the vaccine, said Mark Feinberg, vice president for medical affairs and policy for Merck.

Continuing research could be compromised, he said, if participants were told immediately whether they received the placebo or the vaccine. Vaccine researchers are scheduled to meet in Seattle on Nov. 7.

"Given the complexity of the issue, we feel the best conclusions will be reached when all the data are analyzed in their entirety," Feinberg said from Atlanta, where he was traveling.

He added that individual participants who want to know whether they received the vaccine will be told. Researchers also are counseling all study participants that the vaccine may have increased HIV risk for those who received it.

Other AIDS studies also have had unexpected results. Trials of two vaginal microbicide gels to prevent HIV led to more infections among those using the products instead of placebos. A massive study in Zimbabwe of the ability of HIV counseling and testing to prevent the spread of the epidemic found more infections among those with expanded access to testing.


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