title: Phase I therapeutic trial of the HIV-1 Tat protein and long term follow-up.
abstract: 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.
authors.affiliation: National AIDS Center, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Olimpia
authors.initials: O
authors.lastname: Longo
authors.forename: Antonella
authors.initials: A
authors.lastname: Tripiciano
authors.forename: Valeria
authors.initials: V
authors.lastname: Fiorelli
authors.forename: Stefania
authors.initials: S
authors.lastname: Bellino
authors.forename: Arianna
authors.initials: A
authors.lastname: Scoglio
authors.forename: Barbara
authors.initials: B
authors.lastname: Collacchi
authors.forename: Maria Josè Ruiz
authors.initials: MJ
authors.lastname: Alvarez
authors.forename: Vittorio
authors.initials: V
authors.lastname: Francavilla
authors.forename: Angela
authors.initials: A
authors.lastname: Arancio
authors.forename: Giovanni
authors.initials: G
authors.lastname: Paniccia
authors.forename: Adriano
authors.initials: A
authors.lastname: Lazzarin
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tambussi
authors.forename: Chiara Tassan
authors.initials: CT
authors.lastname: Din
authors.forename: Raffaele
authors.initials: R
authors.lastname: Visintini
authors.forename: Pasquale
authors.initials: P
authors.lastname: Narciso
authors.forename: Andrea
authors.initials: A
authors.lastname: Antinori
authors.forename: Gianpiero
authors.initials: G
authors.lastname: D'Offizi
authors.forename: Marina
authors.initials: M
authors.lastname: Giulianelli
authors.forename: Maria
authors.initials: M
authors.lastname: Carta
authors.forename: Aldo
authors.initials: A
authors.lastname: Di Carlo
authors.forename: Guido
authors.initials: G
authors.lastname: Palamara
authors.forename: Massimo
authors.initials: M
authors.lastname: Giuliani
authors.forename: Maria Elena
authors.initials: ME
authors.lastname: Laguardia
authors.forename: Paolo
authors.initials: P
authors.lastname: Monini
authors.forename: Mauro
authors.initials: M
authors.lastname: Magnani
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Ensoli
authors.forename: Barbara
authors.initials: B
authors.lastname: Ensoli
mesh_terms: 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
chemical_list: D016915:AIDS Vaccines; D015483:HIV Antibodies; C421254:human immunodeficiency virus type 1 Tat vaccine; D015847:Interleukin-4; D007371:Interferon-gamma