International clinical trials of HIV vaccines: II. phase I trial of an HIV-1 synthetic peptide vaccine evaluating an accelerated immunization schedule in Yunnan, China.

A Phase 1, double-blind, placebo controlled trial was conducted in Longchuan County, China, to evaluate the safety and immunogenicity of a prototype HIV-1 synthetic peptide vaccine in a target population at risk for HIV infection, and to establish the infrastructure for future large-scale HIV vaccine efficacy trials. Subjects were randomly assigned to receive 100 microg or 500 microg of vaccine or alum placebo, and were given three injections at an accelerated 0, 1, and 2 month schedule. The vaccine was well tolerated with no significant local or systemic reactions observed in any subjects. Fifty-five percent (100 microg dose) and 64% (500 microg dose) of subjects who received the vaccine produced binding antibody to the immunogen as determined by ELISA. However, HIV-1 (MN) neutralizing antibody was detected in only 23% (3/13) of subjects with detectable HIV-1 specific binding antibody. It was concluded that this prototype HIV-1 synthetic peptide vaccine was well tolerated, safe and immunogenic, and that a 0, 1, 2 month schedule was not as effective in stimulating HIV-1 specific neutralizing antibodies compared with previous trials utilizing a 0, 1, 6 month schedule. Finally, this trial demonstrated that well-designed HIV vaccine trials can be performed at this clinical trials site in Yunnan, China, and that this site should be considered for conducting larger safety, immunogenicity and efficacy trials of candidate HIV vaccines.

International clinical trials of HIV vaccines: I. Phase I trial of an HIV-1 synthetic peptide vaccine in Bangkok, Thailand.

A randomized, double blind, placebo controlled Phase I trial of a prototype human immunodeficiency virus type 1 (HIV-1) synthetic peptide vaccine was conducted in Bangkok, Thailand, to evaluate the safety and immunogenicity of the vaccine in a population of healthy adults at low risk for HIV infection, and to establish essential infrastructure for future HIV vaccine trials in Thailand. Thirty volunteers (25 males; 5 females) were recruited and randomized into 3 groups, receiving 3 intramuscular injections of either 100 micrograms vaccine (N = 12) or 500 micrograms vaccine (N = 12) or alum placebo (N = 6) on weeks 0, 4 and 25. The vaccine was well tolerated without any serious adverse effects. HIV-1 specific ELISA responses were detected in 20/24 subjects who received the vaccine, with V3 binding antibody titers ranging from 1:69 to 1:5,041. HIV-1 (MN) specific neutralizing antibody was detected in 19/20 of subjects with detectable HIV-1 specific binding antibody. Neutralization titers ranged from 1:14 to 1:1,294, which were less than titers observed in HIV-infected subjects. The results of this study indicate that the vaccine was well tolerated, and that the vaccine stimulated anti-HIV humoral immune responses in Thai subjects. The successful undertaking of this first HIV vaccine trial conducted in Thailand provided important preparatory information surrounding volunteer recruitment and motivations, and paves the way for future trials of HIV vaccines in Thailand.