Document 2815 DOCN M94A2815 TI Lymphoproliferative responses in HIV-1-seropositive volunteers pre and post immunization with immuno rgp160. European Multinational Immuno AIDS Vaccine Study Group. DT 9412 AU Mannhalter JW; Eibl MM; Wahren B; Blazevic V; Goebel FD SO Int Conf AIDS. 1994 Aug 7-12;10(1):219 (abstract no. PB0305). Unique Identifier : AIDSLINE ICA10/94369760 AB OBJECTIVE: To evaluate antigen- and mitogen-induced lymphoproliferative responses in two groups of HIV-1-seropositive volunteers (randomized according to different CD4 strata: CD4 counts > 500 and CD4 counts from 200 to 500) pre and post immunization with the IMMUNO rgp160 AIDS candidate vaccine. METHODS: In a double-blind, placebo-controlled phase I/II study, vaccinees got 6 monthly intramuscular injections of either the AIDS candidate vaccine (containing 100 ug rgp160 IIIB per dose) or placebo (adjuvant only). One half of the volunteers received the vaccine, the other half placebo. At various time points pre and post immunization, lymphoproliferative responses to antigens (HIV-1 envelope proteins, tetanus toxoid, CMV antigen, alloantigens) and mitogens (PWM, PHA) were assessed. RESULTS: Prior to immunization with the AIDS candidate vaccine, rgp160-induced lymphocyte proliferation was absent or very low in all HIV-1-seropositive volunteers. Responses to recall antigens and mitogens were observed in both groups of volunteers, but were lower in magnitude than in HIV-1-seronegative controls. Proliferation in response to alloantigens was comparable in HIV-1-seropositive and HIV-1-seronegative subjects. Post immunization with the rgp160 vaccine, HIV-1 envelope-specific lymphoproliferative responses were found in one half of the volunteers with CD4 > 500 and in one third of the subjects with CD4 between 200 and 500 (note that only half of the volunteers received the vaccine). CONCLUSIONS: The IMMUNO AIDS candidate vaccine induces HIV-1 env-specific T cell memory in HIV-1-seropositives with CD4-pos. T cells > 500 and CD4-pos. T cells between 200 and 500. DE Antigens/IMMUNOLOGY AIDS Vaccines/*THERAPEUTIC USE Gene Products, env/PHARMACOLOGY/*THERAPEUTIC USE Human HIV Infections/IMMUNOLOGY/*THERAPY HIV-1/*IMMUNOLOGY Immunization Immunologic Memory *Immunotherapy, Active *Lymphocyte Transformation/DRUG EFFECTS Mitogens/PHARMACOLOGY Protein Precursors/PHARMACOLOGY/*THERAPEUTIC USE Recombinant Proteins/PHARMACOLOGY/THERAPEUTIC USE T-Lymphocyte Subsets/IMMUNOLOGY Vaccines, Synthetic/THERAPEUTIC USE CLINICAL TRIAL CLINICAL TRIAL, PHASE I CLINICAL TRIAL, PHASE II MEETING ABSTRACT RANDOMIZED CONTROLLED TRIAL SOURCE: National Library of Medicine. NOTICE: This material may be protected by Copyright Law (Title 17, U.S.Code).