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

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

Research output: Contribution to journalArticlepeer-review


Objectives: To antagonize the deleterious effects of the HIV-1 toxin extracellular Tat on uninfected immune cells, we developed a new strategy of anti-HFV-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 immunocompromized 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.

Original languageEnglish
Pages (from-to)293-298
Number of pages6
JournalJournal of Human Virology
Issue number4
Publication statusPublished - May 1998


  • AIDS
  • Immunization
  • Immunotherapy
  • Tat protein

ASJC Scopus subject areas

  • Virology


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