The preventive phase I trial with the HIV-1 Tat-based vaccine

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

Research output: Contribution to journalArticle

Abstract

The native HIV-1 Tat protein was chosen as vaccine candidate for phase I clinical trials based on its role in the natural infection and AIDS pathogenesis, on the association of Tat-specific immune response with the asymptomatic stage as well as on its sequence conservation among HIV clades. A randomized, double blind, placebo-controlled phase I study (ISS P-001) was conducted in healthy adult volunteers without identifiable risk of HIV infection. Tat was administered 5 times monthly, subcute in alum or intradermic alone at 7.5 μg, 15 μg or 30 μg, respectively (ClinicalTrials.gov identifier: NCT00529698). Vaccination with Tat resulted to be safe and well tolerated (primary endpoint) both locally and systemically. In addition, Tat induced both Th1 and Th2 type specific immune responses in all subjects (secondary endpoint) with a wide spectrum of functional antibodies that are rarely seen in natural infection, providing key information for further clinical development of the Tat vaccine candidate.

Original languageEnglish
Pages (from-to)371-378
Number of pages8
JournalVaccine
Volume28
Issue number2
DOIs
Publication statusPublished - Dec 11 2009

Keywords

  • Clinical trials
  • HIV-1 Tat
  • 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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  • Cite this

    Ensoli, B., Fiorelli, V., Ensoli, F., Lazzarin, A., Visintini, R., Narciso, P., Di Carlo, A., Tripiciano, A., Longo, O., Bellino, S., Francavilla, V., Paniccia, G., Arancio, A., Scoglio, A., Collacchi, B., Ruiz Alvarez, M. J., Tambussi, G., Tassan Din, C., Palamara, G., ... Garaci, E. (2009). The preventive phase I trial with the HIV-1 Tat-based vaccine. Vaccine, 28(2), 371-378. https://doi.org/10.1016/j.vaccine.2009.10.038