Long-term safety analysis of preventive HIV-1 vaccines evaluated in AIDS vaccine evaluation group NIAID-sponsored Phase I and II clinical trials.

Publication Type
Journal Article
Year of Publication
Gilbert, P B; Chiu, Y-L; Allen, M; Lawrence, D N; Chapdu, C; Israel, H; Holman, D; Keefer, M C; Wolff, M; Frey, S E; NIAID HIV Vaccine Trials Network
Date Published
2003 Jun 20
Adolescent; Adult; AIDS Vaccines; Canarypox virus; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Double-Blind Method; Female; HIV-1; Humans; Male; Middle Aged; National Institutes of Health (U.S.); Randomized Controlled Trials as Topic; Salmonella; Time; United States; Vaccines, Subunit; Vaccines, Synthetic; Vaccinia virus

This report evaluates long-term safety data from 3189 human immunodeficiency virus type 1 (HIV-1) uninfected, healthy volunteers who were enrolled into 51 National Institute of Allergy and Infectious Diseases (NIAID)-sponsored Phase I and II multicentred, randomized, double-blind trials of recombinant HIV-1 subunit vaccines (23 studies), synthetic peptide vaccines (7 studies), live vaccinia-vector recombinant envelope vaccines (7 studies), canarypox vector recombinant vaccines (13 studies), a DNA vaccine (1 study), and a Salmonella-vector vaccine (1 study). During the 12,340 person-years of follow-up, participants were monitored for adverse events including immune dysfunction/autoimmunity, anaphylaxis, cancer, death, and vaccine allergy. The analysis provides evidence that a preparation of a C4-V3 polypeptide vaccine emulsified in incomplete Freund's caused serious toxicity, but otherwise no safety problems considered serious were identified for any of the vaccines and adjuvants studied. These data serve to solidify the growing safety base of current vaccine technologies utilized in candidate vaccines for HIV-1 infection.