Safety and immunogenicity of a fully glycosylated recombinant gp160 human immunodeficiency virus type 1 vaccine in subjects at low risk of infection. National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group Network

J Infect Dis. 1993 Dec;168(6):1387-95. doi: 10.1093/infdis/168.6.1387.

Abstract

Recombinant gp160 derived from human immunodeficiency virus type 1 (HIV-1)IIIB and produced in mammalian tissue culture cells using a vaccinia virus expression system (rgp160-mam) was evaluated as a vaccine in combination with alum and deoxycholate adjuvant. Sixty low-risk, uninfected subjects received 12.5 micrograms, 50.0 micrograms, or adjuvant control at 0, 1, 6, and 12 months in a randomized, double-blind dose-escalation study. A single injection of 200 micrograms of vaccine was given at 18 months in an open study to 9 vaccines who had received 50 micrograms. The vaccine was safe. Six of 16 subjects receiving 50 micrograms developed neutralizing antibody to HIV-1IIIB. Seven of the 9 boosted with 200 micrograms of vaccine at 18 months developed neutralizing antibodies. Lymphocyte proliferation to rgp160-mam and baculovirus-derived rgp160 and rgp120 was induced in both groups (12.5 and 50.0 micrograms) and appeared after the first dose. Further studies with higher doses of rgp160-mam and vaccines derived from other strains of HIV-1 are warranted.

Publication types

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

MeSH terms

  • AIDS Vaccines / administration & dosage
  • AIDS Vaccines / adverse effects
  • AIDS Vaccines / immunology*
  • Adjuvants, Immunologic
  • Adolescent
  • Adult
  • Aged
  • Animals
  • Antibodies, Antinuclear / immunology
  • Cells, Cultured
  • Double-Blind Method
  • Female
  • Gene Products, env / adverse effects
  • Gene Products, env / chemistry
  • Gene Products, env / immunology*
  • Glycosylation
  • HIV Envelope Protein gp160
  • HIV-1 / immunology*
  • Humans
  • Lymphocytes / immunology
  • Male
  • Middle Aged
  • Protein Precursors / adverse effects
  • Protein Precursors / chemistry
  • Protein Precursors / immunology*
  • Safety
  • Vaccines, Synthetic / administration & dosage
  • Vaccines, Synthetic / adverse effects
  • Vaccines, Synthetic / immunology
  • Vero Cells

Substances

  • AIDS Vaccines
  • Adjuvants, Immunologic
  • Antibodies, Antinuclear
  • Gene Products, env
  • HIV Envelope Protein gp160
  • Protein Precursors
  • Vaccines, Synthetic