A Gringeri, E Santagostino, M Muça-Perja, P M Mannucci, J F Zagury, B Bizzini, A Lachgar, M Carcagno, J Rappaport, M Criscuolo, W Blattner, A Burny, R C Gallo, D Zagury
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引用次数: 0
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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