HIV vaccines for prevention of infection and disease in humans

Phase I and II studies have been carried out with several candidate HIV-1 vaccines in seronegative volunteers. Vaccines consisting of rgp 120 stimulated moderate levels of neutralizing antibodies against homologous, TCLA adapted viruses, but did not induce CD8+ CTL responses. Canarypox vectors stimulate CD8+ CTL responses, but little neutralizing activity. The latter can be increased in titer by boosting recipients of canarypox vectors with rgp120 vaccines. Large-scale placebo-controlled efficacy trials are underway with two rgp120 vaccines: AIDSVAX B/B (VaxGen, Inc.) in the United States, and AIDSVAX B/E in Thailand. The canarypox-rgp120 combined regimen has been proposed for study in an intermediate-sized, "test-of-concept" efficacy trial by the NIAID-sponsored HVTN, with an experimental design intended to provide information on the potential in vitro correlates of immunity. The results from these studies, and the methodology used in their conduct, should facilitate the refinement of conventional and novel approaches to the development of safe and effective HIV vaccines.