Safety and immunogenicity of HIV-1 Tat toxoid in immunocompromised HIV-1-infected patients |
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Authors: | Gringeri A Santagostino E Muça-Perja M Mannucci P M Zagury J F Bizzini B Lachgar A Carcagno M Rappaport J Criscuolo M Blattner W Burny A Gallo R C Zagury D |
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Affiliation: | Hemophilia and Thrombosis Center Angelo Bianchi Bonomi, IRCCS Maggiore Hospital, Milan, Italy. hemophilia_ctr@polic.cilea.it |
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Abstract: | 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. |
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