title: The preventive phase I trial with the HIV-1 Tat-based vaccine.
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.
authors.affiliation: National AIDS Center, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy. barbara.ensoli@iss.it
authors.forename: Barbara
authors.initials: B
authors.lastname: Ensoli
authors.forename: Valeria
authors.initials: V
authors.lastname: Fiorelli
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Ensoli
authors.forename: Adriano
authors.initials: A
authors.lastname: Lazzarin
authors.forename: Raffaele
authors.initials: R
authors.lastname: Visintini
authors.forename: Pasquale
authors.initials: P
authors.lastname: Narciso
authors.forename: Aldo
authors.initials: A
authors.lastname: Di Carlo
authors.forename: Antonella
authors.initials: A
authors.lastname: Tripiciano
authors.forename: Olimpia
authors.initials: O
authors.lastname: Longo
authors.forename: Stefania
authors.initials: S
authors.lastname: Bellino
authors.forename: Vittorio
authors.initials: V
authors.lastname: Francavilla
authors.forename: Giovanni
authors.initials: G
authors.lastname: Paniccia
authors.forename: Angela
authors.initials: A
authors.lastname: Arancio
authors.forename: Arianna
authors.initials: A
authors.lastname: Scoglio
authors.forename: Barbara
authors.initials: B
authors.lastname: Collacchi
authors.forename: Maria Josè
authors.initials: MJ
authors.lastname: Ruiz Alvarez
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tambussi
authors.forename: Chiara
authors.initials: C
authors.lastname: Tassan Din
authors.forename: Guido
authors.initials: G
authors.lastname: Palamara
authors.forename: Alessandra
authors.initials: A
authors.lastname: Latini
authors.forename: Andrea
authors.initials: A
authors.lastname: Antinori
authors.forename: Gianpiero
authors.initials: G
authors.lastname: D'Offizi
authors.forename: Massimo
authors.initials: M
authors.lastname: Giuliani
authors.forename: Marina
authors.initials: M
authors.lastname: Giulianelli
authors.forename: Maria
authors.initials: M
authors.lastname: Carta
authors.forename: Paolo
authors.initials: P
authors.lastname: Monini
authors.forename: Mauro
authors.initials: M
authors.lastname: Magnani
authors.forename: Enrico
authors.initials: E
authors.lastname: Garaci
mesh_terms: D016915:AIDS Vaccines / Q000009:adverse effects / Q000627:therapeutic use; D000328:Adult; D018604:Epitope Mapping; D005260:Female; D015658:HIV Infections / Q000276:immunology* / Q000517:prevention & control*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007111:Immunity, Cellular / Q000276:immunology; D007371:Interferon-gamma / Q000378:metabolism; D015847:Interleukin-4 / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D013601:T-Lymphocytes / Q000276:immunology
chemical_list: D016915:AIDS Vaccines; C421254:human immunodeficiency virus type 1 Tat vaccine; D015847:Interleukin-4; D007371:Interferon-gamma