title: 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.
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.
authors.affiliation: Dept. of Medicine, St. Louis University School of Medicine, MO 63104.
authors.forename: R B
authors.initials: RB
authors.lastname: Belshe
authors.forename: M L
authors.initials: ML
authors.lastname: Clements
authors.forename: R
authors.initials: R
authors.lastname: Dolin
authors.forename: B S
authors.initials: BS
authors.lastname: Graham
authors.forename: J
authors.initials: J
authors.lastname: McElrath
authors.forename: G J
authors.initials: GJ
authors.lastname: Gorse
authors.forename: D
authors.initials: D
authors.lastname: Schwartz
authors.forename: M C
authors.initials: MC
authors.lastname: Keefer
authors.forename: P
authors.initials: P
authors.lastname: Wright
authors.forename: L
authors.initials: L
authors.lastname: Corey
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D000276:Adjuvants, Immunologic; D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D000974:Antibodies, Antinuclear / Q000276:immunology; D002478:Cells, Cultured; D004311:Double-Blind Method; D005260:Female; D015686:Gene Products, env / Q000009:adverse effects / Q000737:chemistry / Q000276:immunology*; D006031:Glycosylation; D019302:HIV Envelope Protein gp160; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D008214:Lymphocytes / Q000276:immunology; D008297:Male; D008875:Middle Aged; D011498:Protein Precursors / Q000009:adverse effects / Q000737:chemistry / Q000276:immunology*; D012449:Safety; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014709:Vero Cells
chemical_list: D016915:AIDS Vaccines; D000276:Adjuvants, Immunologic; D000974:Antibodies, Antinuclear; D015686:Gene Products, env; D019302:HIV Envelope Protein gp160; D011498:Protein Precursors; D014614:Vaccines, Synthetic