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

J Acquir Immune Defic Syndr. 2002 Mar 1;29(3):254-61. doi: 10.1097/00126334-200203010-00005.

Abstract

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • AIDS Vaccines / adverse effects*
  • AIDS Vaccines / genetics
  • AIDS Vaccines / immunology*
  • Adult
  • Double-Blind Method
  • Female
  • HIV Antibodies / blood
  • HIV Envelope Protein gp120 / adverse effects
  • HIV Envelope Protein gp120 / genetics
  • HIV Envelope Protein gp120 / immunology*
  • HIV Infections / diagnosis
  • HIV Seronegativity / immunology
  • HIV-1 / immunology
  • Humans
  • Immunization Schedule
  • Male
  • Neutralization Tests
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / genetics
  • Recombinant Proteins / immunology
  • T-Lymphocytes, Cytotoxic / immunology
  • Vaccines, Combined
  • Vaccines, Synthetic

Substances

  • AIDS Vaccines
  • ALVAC-HIV-1 vCP250
  • HIV Antibodies
  • HIV Envelope Protein gp120
  • Recombinant Proteins
  • Vaccines, Combined
  • Vaccines, Synthetic