Preventing Discrimination against Volunteers in Preventive HIV Vaccine Efficacy Trials: Conference Summary

Abstract

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 Phase I/II vaccine trials have had positive HIV antibody tests due to vaccine-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 likelihood of such tests resulting in discrimination will depend on the type of 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 estimate the frequency with which volunteers in a study of gp120 preventive 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 procedures or termination of trials if volunteers experience severe social harm due to their participation in trials.