A phase II study of two HIV type 1 envelope vaccines, comparing their immunogenicity in populations at risk for acquiring HIV type 1 infection. AIDS Vaccine Evaluation Group

AIDS Res Hum Retroviruses. 2000 Jun 10;16(9):907-19. doi: 10.1089/08892220050042846.

Abstract

Several immunogens induce HIV-specific neutralization and in vitro lymphoproliferation in adults at low HIV-1 risk, but responses in persons at high HIV-1 risk are not known. We performed a multicenter, double-blinded, adjuvant-controlled trial with two gp120 vaccines in 296 HIV-1-uninfected volunteers, including 176 reporting higher HIV-1 risk activities. The immunogens were remarkably well tolerated. After three immunizations, 210 of 241 vaccinees (87%) developed neutralizing antibodies, which persisted in 59% after 2 years. The injection drug users receiving SF-2/gp120 had decreased antibody responses relative to the lower risk groups. Envelope-specific lymphoproliferation peaked after two immunizations, and 54% of vaccinees mounted a DTH reaction to gp120 after 4 years. In summary, these immunogens have low adverse reactogenicity and induce durable antibody and T cell responses to the prototype strains. Unexpected differences in antibody responses among diverse HIV-1 risk strata lend support to the conduct of expanded phase II trials in populations other than low-risk volunteers.

Publication types

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

MeSH terms

  • AIDS Vaccines / adverse effects
  • AIDS Vaccines / immunology*
  • AIDS Vaccines / pharmacology*
  • Adolescent
  • Adult
  • Amino Acid Sequence
  • Double-Blind Method
  • Female
  • HIV Antibodies / biosynthesis
  • HIV Antigens / genetics
  • HIV Envelope Protein gp120 / immunology
  • HIV Infections / immunology
  • HIV Infections / prevention & control*
  • HIV-1* / genetics
  • HIV-1* / immunology
  • Humans
  • Hypersensitivity, Delayed
  • In Vitro Techniques
  • Lymphocyte Activation
  • Male
  • Middle Aged
  • Molecular Sequence Data
  • Neutralization Tests
  • Peptide Fragments / immunology
  • Risk-Taking
  • Safety
  • Time Factors

Substances

  • AIDS Vaccines
  • HIV Antibodies
  • HIV Antigens
  • HIV Envelope Protein gp120
  • HIV envelope protein gp120 (305-321)
  • Peptide Fragments