"Trials Set in High-Risk Populations"

Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.

"Trials Set in High-Risk Populations"

Science (12/11/92) Vol. 258, No. 5089, P. 1729
Cohen, Jon

Abstract: The National Institute of Allergy and Infectious Diseases recently announced that it is launching a trial of two preventive HIV vaccines that will be administered to people considered to be at high risk of HIV infection in addition to those at low risk. Small-scale tests of preventive vaccines, conducted over the past six years, have included only volunteers from low-risk groups. The placebo-controlled, Phase II trial will involve 330 uninfected volunteers at five different university medical centers. The volunteers will include drug users, people with sexually transmitted diseases, and minorities. The test will assess whether people at high risk and minorities have different responses from the healthy whites who dominated the earlier trials. NIAID's Patricia Fast, a trial coordinator, said that some high-risk uninfected subjects may already have been exposed to HIV, an exposure that might have altered their immune systems. Because the new trial will enroll hundreds instead of dozens of people, safety problems with the vaccines are also more likely to emerge. Both vaccines in the trial are genetically engineered versions of the HIV surface protein called gp120. It is still undetermined when a Phase III trial in thousands of people at high-risk, which is the most conclusive test of AIDS vaccine efficacy, will take place.

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