title: Safety and immunogenicity of a gp120-depleted, inactivated HIV-1 immunogen: results of a double-blind, adjuvant controlled trial.
abstract: We report the safety and immunogenicity results of a double-blind adjuvant controlled trial of the human immunodeficiency virus type 1 (HIV-1) immunogen. Healthy, asymptomatic HIV-1-seropositive individuals received either three 100 microgram doses of the inactivated HIV-1 antigen in incomplete Freund's adjuvant (IFA) or three doses of IFA alone. The results of this study show that this HIV-1 immunogen is safe, with mild and transient adverse events. No difference in the number or type of adverse events was noted between the treatment groups. Rises in HIV-1-specific humoral and cell-mediated immune (CMI) responses were also noted, favoring the HIV-1 immunogen-treated group. The results of this study confirm and extend the safety and immunogenicity profile of this HIV-1 immunotherapeutic agent. The observation that this treatment can augment HIV-1-specific CMI is encouraging because this immunological marker may represent a key surrogate end point in HIV-1 infection and disease.
authors.affiliation: Immune Response Corporation, Carlsbad, CA 92008, USA.
authors.forename: R J
authors.initials: RJ
authors.lastname: Trauger
authors.forename: A E
authors.initials: AE
authors.lastname: Daigle
authors.forename: W
authors.initials: W
authors.lastname: Giermakowska
authors.forename: R B
authors.initials: RB
authors.lastname: Moss
authors.forename: F
authors.initials: F
authors.lastname: Jensen
authors.forename: D J
authors.initials: DJ
authors.lastname: Carlo
mesh_terms: D016915:AIDS Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D000956:Antigens, Viral / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use; D015331:Cohort Studies; D004311:Double-Blind Method; D005620:Freund's Adjuvant / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use; D015483:HIV Antibodies / Q000096:biosynthesis; D016655:HIV Core Protein p24 / Q000276:immunology; D006679:HIV Seropositivity / Q000276:immunology / Q000628:therapy*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007111:Immunity, Cellular; D008213:Lymphocyte Activation; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use
chemical_list: D016915:AIDS Vaccines; D000956:Antigens, Viral; D015483:HIV Antibodies; D016655:HIV Core Protein p24; D015164:Vaccines, Inactivated; D005620:Freund's Adjuvant