Safety and immunogenicity of HIV-1 Tat toxoid in immunocompromised HIV-1-infected patients

• Published in: Journal of human virology Vol. 1; no. 4; p. 293
• Main 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
• Format: Journal Article
• Language: English
• Published: United States 01-05-1998
• Subjects: Acquired Immunodeficiency Syndrome - immunology; Acquired Immunodeficiency Syndrome - therapy; Acquired Immunodeficiency Syndrome - virology; Adult; AIDS Vaccines - adverse effects; AIDS Vaccines - immunology; AIDS Vaccines - therapeutic use; CD4 Lymphocyte Count; Disease Progression; Female; Follow-Up Studies; Gene Products, tat - adverse effects; Gene Products, tat - immunology; Gene Products, tat - therapeutic use; HIV Antibodies - immunology; HIV Core Protein p24 - immunology; HIV-1 - chemistry; HIV-1 - immunology; Humans; Immunocompromised Host; Male; Pilot Projects; tat Gene Products, Human Immunodeficiency Virus
• ISSN: 1090-9508

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.
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).
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.
These results provide initial evidence of safety and potency of Tat toxoid vaccination in HIV-1-infected individuals.