Phase I clinical trial with HIV-1 gp160 plasmid vaccine in HIV-1-infected asymptomatic subjects.
The aim of the study was to investigate the safety of an HIV-1 gp160 plasmid vaccine. Four asymptomatic HIV-1-infected subjects with CD4+ lymphocyte counts >500/microl were injected with four times 400 microg of HIV-1 modified gp160 env and rev coding DNA vaccine at 0, 4, 10 and 28 weeks. Safety parameters, including autoimmune antibodies as well as CD4+/CD8+ cell counts and HIV-1 plasma concentrations, were monitored for 52 weeks after the first vaccine application. Follow-up data for more than 3 years are now available. The DNA vaccine proved to be safe and, specifically, did not induce anti-DNA autoimmune antibodies. Vaccination had no long-term effects on the CD4+/CD8+ lymphocyte counts, plasma HIV-1 RNA concentrations or disease progression. The present data supplement published data from Philadelphia, USA, where a dose-escalating study (30-300 microg) with the same HIV-1 DNA vaccine was performed.
Weber
R
R
University Hospital of Zurich, Division of Infectious Diseases, Switzerland.
Bossart
W
W
Cone
R
R
Luethy
R
R
Moelling
K
K
D016915:AIDS Vaccines / Q000008:administration & dosage*; D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D019302:HIV Envelope Protein gp160 / Q000008:administration & dosage* / Q000276:immunology; D015658:HIV Infections / Q000517:prevention & control*; D006679:HIV Seropositivity; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D008297:Male; D018579:Patient Selection; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014611:Vaccination / Q000379:methods*
D016915:AIDS Vaccines; D019302:HIV Envelope Protein gp160