PREVENTING DISCRIMINATION AGAINST VOLUNTEERS IN PREVENTIVE HIV VACCINE EFFICACY TRIALS - CONFERENCE SUMMARY

A Workshop was held November 8, 1994 to discuss actual and theoretical risks for discrimination against volunteers in future HIV preventive vaccine efficacy trials. A small proportion of volunteers in ongoing P hase I/II vaccine trials have had positive HIV antibody tests due to v accine-induced HIV antibody responses. Some volunteers had difficulty obtaining health and life insurance, employment with the U.S. military , and with foreign travel. Study staff were able to resolve almost all such problems. Gay men enrolled in prospective seroincidence studies experienced a 1.6% chance per year of undergoing required HIV antibody tests. Among subjects enrolled in future vaccine trials, the likeliho od of such tests resulting in discrimination will depend on the type o f vaccine and antibody tests used. The Americans with Disabilities Act may be used to prevent illegal discrimination against those actually, or erroneously thought to be HIV infected. A study is underway to est imate the frequency with which volunteers in a study of gp120 preventi ve vaccines have actually experienced legal and illegal discrimination as a result of trial participation. Data and Safety Monitoring Boards can evaluate such data and should recommend modification of trial pro cedures or termination of trials if volunteers experience severe socia l harm due to their participation in trials.