Phase I therapeutic trial of the HIV-1 Tat protein and long term follow-up

Olimpia Longo, Antonella Tripiciano, Valeria Fiorelli, Stefania Bellino, Arianna Scoglio, Barbara Collacchi, Maria Josè Ruiz Alvarez, Vittorio Francavilla, Angela Arancio, Giovanni Paniccia, Adriano Lazzarin, Giuseppe Tambussi, Chiara Tassan Din, Raffaele Visintini, Pasquale Narciso, Andrea Antinori, Gianpiero D'Offizi, Marina Giulianelli, Maria Carta, Aldo Di CarloGuido Palamara, Massimo Giuliani, Maria Elena Laguardia, Paolo Monini, Mauro Magnani, Fabrizio Ensoli, Barbara Ensoli

Research output: Contribution to journalArticlepeer-review


A randomized, double blind, placebo-controlled phase I vaccine trial based on the native Tat protein was conducted in HIV-infected asymptomatic individuals. The vaccine was administered five times subcute with alum or intradermally without adjuvant at 7.5 μg, 15 μg or 30 μg doses, respectively. The Tat vaccine was well tolerated both locally and systemically and induced and/or maintained Tat-specific T helper (Th)-1 T-cell responses and Th-2 responses in all subjects with a wide spectrum of functional anti-Tat antibodies, rarely seen in HIV-infected subjects. The data indicate the achievement of both the primary (safety) and secondary (immunogenicity) endpoints of the study.

Original languageEnglish
Pages (from-to)3306-3312
Number of pages7
Issue number25-26
Publication statusPublished - May 26 2009


  • Clinical trial
  • HIV
  • Vaccination

ASJC Scopus subject areas

  • Immunology and Microbiology(all)
  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • veterinary(all)
  • Molecular Medicine


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