       Document 0586
 DOCN  M9610586
 TI    Safety and immunogenicity of a gp120-depleted, inactivated HIV-1
       immunogen: results of a double-blind, adjuvant controlled trial.
 DT    9601
 AU    Trauger RJ; Daigle AE; Giermakowska W; Moss RB; Jensen F; Carlo DJ;
       Immune Response Corporation, Carlsbad, CA 92008, USA.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1995;10 Suppl 2:S74-82.
       Unique Identifier : AIDSLINE MED/96033816
 AB    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.
 DE    Antigens, Viral/ADVERSE EFFECTS/IMMUNOLOGY/THERAPEUTIC USE  AIDS
       Vaccines/ADVERSE EFFECTS/IMMUNOLOGY/*THERAPEUTIC USE  Cohort Studies
       Double-Blind Method  Freund's Adjuvant/ADVERSE
       EFFECTS/STANDARDS/THERAPEUTIC USE  Human  HIV Antibodies/BIOSYNTHESIS
       HIV Core Protein p24/IMMUNOLOGY  HIV Seropositivity/IMMUNOLOGY/*THERAPY
       HIV-1/*IMMUNOLOGY  Immunity, Cellular  Lymphocyte Transformation
       Vaccines, Inactivated/ADVERSE EFFECTS/IMMUNOLOGY/THERAPEUTIC USE
       CLINICAL TRIAL  CONTROLLED CLINICAL TRIAL  JOURNAL ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

