The preventive phase I trial with the HIV-1 Tat-based vaccine.
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.
Ensoli
Barbara
B
National AIDS Center, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy. barbara.ensoli@iss.it
Fiorelli
Valeria
V
Ensoli
Fabrizio
F
Lazzarin
Adriano
A
Visintini
Raffaele
R
Narciso
Pasquale
P
Di Carlo
Aldo
A
Tripiciano
Antonella
A
Longo
Olimpia
O
Bellino
Stefania
S
Francavilla
Vittorio
V
Paniccia
Giovanni
G
Arancio
Angela
A
Scoglio
Arianna
A
Collacchi
Barbara
B
Ruiz Alvarez
Maria Josè
MJ
Tambussi
Giuseppe
G
Tassan Din
Chiara
C
Palamara
Guido
G
Latini
Alessandra
A
Antinori
Andrea
A
D'Offizi
Gianpiero
G
Giuliani
Massimo
M
Giulianelli
Marina
M
Carta
Maria
M
Monini
Paolo
P
Magnani
Mauro
M
Garaci
Enrico
E
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
D016915:AIDS Vaccines; C421254:human immunodeficiency virus type 1 Tat vaccine; D015847:Interleukin-4; D007371:Interferon-gamma