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Safety and immunogenicity of HIV-1 Tat toxoid in immunocompromised HIV-1-infected patients [see comments]
Gringeri A; Santagostino E; Muca-Perja M; Mannucci PM; Zagury JF;
July 30, 1999
J Hum Virol. 1998 May-Jun;1(4):293-8. Unique Identifier : AIDSLINE

OBJECTIVES: To antagonize the deleterious effects of the HIV-1 toxin extracellular Tat on uninfected immune cells, we developed a new strategy of anti-HIV-1 vaccine using an inactivated but immunogenic Tat (Tat toxoid). Tat toxoid has been assayed for safety and immunogenicity in seropositive patients. METHOD: The phase I vaccine clinical trial testing Tat toxoid preparation in Seppic Isa 51 oil adjuvant was performed on 14 HIV-1-infected asymptomatic although biologically immunocompromised individuals (500-200 CD4+ cells/mm3). RESULTS: Following as many as 8 injections, no clinical defects were observed. All patients exhibited an antibody (Ab) response to Tat, and some had cell-mediated immunity (CMI) as evaluated by skin test in vivo and T-cell proliferation in vitro. CONCLUSION: These results provide initial evidence of safety and potency of Tat toxoid vaccination in HIV-1-infected individuals.

CLINICAL TRIAL CLINICAL TRIAL, PHASE I JOURNAL ARTICLE Acquired Immunodeficiency Syndrome/*IMMUNOLOGY/THERAPY/VIROLOGY Adult AIDS Vaccines/ADVERSE EFFECTS/*IMMUNOLOGY/THERAPEUTIC USE Comparative Study CD4 Lymphocyte Count Disease Progression Female Follow-Up Studies Gene Products, tat/ADVERSE EFFECTS/*IMMUNOLOGY/THERAPEUTIC USE Human HIV Antibodies/IMMUNOLOGY HIV Core Protein p24/IMMUNOLOGY HIV-1/*CHEMISTRY/IMMUNOLOGY Immunocompromised Host Male Pilot Projects