Safety and immunogenicity of a high-titered canarypox vaccine in combination with rgp120 in a diverse population of HIV-1-uninfected adults: AIDS Vaccine Evaluation Group Protocol 022A.

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

To test the safety and immunogenicity of a high-titered preparation of ALVAC-HIV vCP205 in both high-risk and low-risk persons and to evaluate variations in dosing schedule, we conducted a multicenter, randomized, double-blind trial of this vector in combination with recombinant subunit gp120 in 150 HIV-1-seronegative volunteers. The high-titered ALVAC vaccine was well tolerated; adverse events were minimal and not influenced by dosing. At day 728, the cumulative probability of a cytotoxic T-lymphocyte (CTL) response was 76% (95% confidence interval [CI]: 64%-89%) among volunteers receiving vaccine, and the net amount attributable to vaccination was 50% (CI: 16%; 74%). The net probability of a repeated positive CTL response by day 728 was 50% (CI: 21%; 64%). There was a significant difference in CTL response at day 182 between volunteers who had received four doses versus three doses of vCP205 (42% vs. 24%, p =.052). The CTL response was similar in high-risk volunteers and vaccinia-naive volunteers compared with vaccinia-immune volunteers. Neutralizing antibody responses were detected in 95% of vaccinees at day 287, with higher geometric mean titers in recipients of sequential versus simultaneous dosing of the two vaccines and in vaccinia-naive volunteers. This high-titered preparation of ALVAC-HIV vCP205 in combination with gp120 was safe and immunogenic in a diverse group of HIV-1-seronegative volunteers.

Full Text

Duke Authors

Cited Authors

  • Gupta, K; Hudgens, M; Corey, L; McElrath, MJ; Weinhold, K; Montefiori, DC; Gorse, GJ; Frey, SE; Keefer, MC; Evans, TG; Dolin, R; Schwartz, DH; Harro, C; Graham, B; Spearman, PW; Mulligan, M; Goepfert, P; AIDS Vaccine Evaluation Group,

Published Date

  • March 1, 2002

Published In

Volume / Issue

  • 29 / 3

Start / End Page

  • 254 - 261

PubMed ID

  • 11873074

International Standard Serial Number (ISSN)

  • 1525-4135

Digital Object Identifier (DOI)

  • 10.1097/00126334-200203010-00005


  • eng

Conference Location

  • United States