HIV vaccine trial volunteers may face social blow

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NEW YORK (Reuters Health) - Many volunteers who take part in clinical trials of experimental HIV vaccines report negative social consequences because of their participation in the studies, according to a new report.

By Will Boggs, MD

NEW YORK (Reuters Health) - Many volunteers who take part in clinical trials of experimental HIV vaccines report negative social consequences because of their participation in the studies, according to a new report.

"Since a majority of the negative social impact events were due to negative reactions from friends and family who misinterpreted what a preventive HIV vaccine trial entails, trial sites need to continue their educational efforts with both study participants and with local communities emphasizing that you cannot become HIV-infected from the vaccine itself and that these trials seek HIV-negative individuals to participate," Dr. Jonathan Fuchs told Reuters Health.

Fuchs, from the San Francisco Department of Public Health, and his associates evaluated the negative social impacts reported by 5417 mostly male volunteers in an HIV vaccine efficacy trial.

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Just under 1000 volunteers reported negative social events during 36 months of follow-up.

Most such events were negative reactions from friends, family, and partners, the authors report in the Journal of Acquired Immune Deficiency Syndromes. These reactions were primarily attributed to a misunderstanding of the volunteer's HIV status or risk of infection.

Less than 1 percent of the group reported problems with disability or life insurance, employment, medical or dental care, health insurance, government agencies, or housing.

Among the 368 participants who became infected with HIV after enrollment in the trial, only 12 reported a negative social incident, the investigators say. Most involved personal relationships, such as friends or family members asserting that the vaccine caused the individual to become HIV-infected or more susceptible to infection.

Although the vaccine could affect HIV test results, none of the HIV antibody-related negative social events reported by 29 volunteers were attributed to vaccine-induced antibody results, the researchers note.

"A substantial proportion of vaccinees may test 'false-positive' on a standard HIV antibody screening test," Fuchs explained. "Providers should remember to first ask whether their patients have participated in an HIV vaccine trial before they perform HIV testing, to avoid potential misinterpretation of antibody results and possible social harm."

SOURCE: Journal of Acquired Immune Deficiency Syndromes, November 1, 2007.