title: Induction of humoral and cell-mediated anti-human immunodeficiency virus (HIV) responses in HIV sero-negative volunteers by immunization with recombinant gp160.
abstract: Development of an effective vaccine for prevention of infection with HIV would provide an important mechanism for controlling the AIDS epidemic. In the current study, the first clinical trial of a candidate HIV-1 vaccine initiated in the United States, the safety and immunogenicity of escalating doses (10-1,280 micrograms) of recombinant gp160 (rgp160), were evaluated in 138 HIV-negative volunteers. Maximal antibody responses, as evaluated by ELISA, were seen after immunization with three doses of 1,280 micrograms rgp160. Responses to some specific epitopes of HIV gp160, including the second conserved domain and the CD4 binding site, were seen more frequently than after natural infection. Neutralizing antibodies to the homologous HIV strain, but not heterologous strains, were induced by this regimen. Blastogenic responses to rgp160 were seen in most volunteers receiving at least two doses of > or = 20 micrograms. These envelope-specific T cell responses were also seen against heterologous strains of HIV. No major adverse reactions were seen after immunization. Thus, rgp160 is a safe and immunogenic candidate HIV vaccine; further studies are needed to determine if it will provide any clinical benefit in preventing HIV infection.
authors.affiliation: Critical Care Medicine Department, National Institutes of Health, Bethesda, Maryland 20892.
authors.forename: J A
authors.initials: JA
authors.lastname: Kovacs
authors.forename: M B
authors.initials: MB
authors.lastname: Vasudevachari
authors.forename: M
authors.initials: M
authors.lastname: Easter
authors.forename: R T
authors.initials: RT
authors.lastname: Davey
authors.forename: J
authors.initials: J
authors.lastname: Falloon
authors.forename: M A
authors.initials: MA
authors.lastname: Polis
authors.forename: J A
authors.initials: JA
authors.lastname: Metcalf
authors.forename: N
authors.initials: N
authors.lastname: Salzman
authors.forename: M
authors.initials: M
authors.lastname: Baseler
authors.forename: G E
authors.initials: GE
authors.lastname: Smith
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage / Q000276:immunology*; D000917:Antibody Formation; D015703:Antigens, CD / Q000097:blood; D015704:CD4 Antigens / Q000097:blood; D003001:Cloning, Molecular; D004797:Enzyme-Linked Immunosorbent Assay; D000939:Epitopes / Q000276:immunology; D015686:Gene Products, env / Q000008:administration & dosage / Q000276:immunology*; D015752:Genes, env; D015483:HIV Antibodies / Q000097:blood*; D019302:HIV Envelope Protein gp160; D006679:HIV Seropositivity / Q000097:blood / Q000276:immunology*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007111:Immunity, Cellular; D007117:Immunization, Secondary; D011498:Protein Precursors / Q000008:administration & dosage / Q000276:immunology*; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000276:immunology*
chemical_list: D016915:AIDS Vaccines; D015703:Antigens, CD; D015704:CD4 Antigens; D000939:Epitopes; D015686:Gene Products, env; D015483:HIV Antibodies; D019302:HIV Envelope Protein gp160; D011498:Protein Precursors; D014614:Vaccines, Synthetic