| Literature DB >> 19879233 |
Barbara Ensoli1, 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 Latini, Andrea Antinori, Gianpiero D'Offizi, Massimo Giuliani, Marina Giulianelli, Maria Carta, Paolo Monini, Mauro Magnani, Enrico Garaci.
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 microg, 15 microg or 30 microg, 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.Entities:
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Year: 2009 PMID： 19879233 DOI： 10.1016/j.vaccine.2009.10.038
Source DB: PubMed Journal: Vaccine ISSN： 0264-410X Impact factor: 3.641