Phase I therapeutic trial of the HIV-1 Tat protein and long term follow-up.
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 7.5microg, 15microg or 30microg 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.
Longo
Olimpia
O
National AIDS Center, Istituto Superiore di Sanità, Rome, Italy.
Tripiciano
Antonella
A
Fiorelli
Valeria
V
Bellino
Stefania
S
Scoglio
Arianna
A
Collacchi
Barbara
B
Alvarez
Maria Josè Ruiz
MJ
Francavilla
Vittorio
V
Arancio
Angela
A
Paniccia
Giovanni
G
Lazzarin
Adriano
A
Tambussi
Giuseppe
G
Din
Chiara Tassan
CT
Visintini
Raffaele
R
Narciso
Pasquale
P
Antinori
Andrea
A
D'Offizi
Gianpiero
G
Giulianelli
Marina
M
Carta
Maria
M
Di Carlo
Aldo
A
Palamara
Guido
G
Giuliani
Massimo
M
Laguardia
Maria Elena
ME
Monini
Paolo
P
Magnani
Mauro
M
Ensoli
Fabrizio
F
Ensoli
Barbara
B
D016915:AIDS Vaccines / Q000009:adverse effects / Q000627:therapeutic use; D001402:B-Lymphocytes / Q000276:immunology; D018791:CD4 Lymphocyte Count; D004311:Double-Blind Method; D005500:Follow-Up Studies; D015483:HIV Antibodies / Q000097:blood; D015658:HIV Infections / Q000628:therapy*; D006801:Humans; D007371:Interferon-gamma / Q000096:biosynthesis; D015847:Interleukin-4 / Q000096:biosynthesis; D019562:Viral Load
D016915:AIDS Vaccines; D015483:HIV Antibodies; C421254:human immunodeficiency virus type 1 Tat vaccine; D015847:Interleukin-4; D007371:Interferon-gamma