Phase I therapeutic trial of the HIV-1 Tat protein and long term follow-up

Olimpia Longo, Antonella Tripiciano, Valeria Fiorelli, Stefania Bellino, Arianna Scoglio, Barbara Collacchi, Maria Josè Ruiz Alvarez, Vittorio Francavilla, Angela Arancio, Giovanni Paniccia, Adriano Lazzarin, Giuseppe Tambussi, Chiara Tassan Din, Raffaele Visintini, Pasquale Narciso, Andrea Antinori, Gianpiero D'Offizi, Marina Giulianelli, Maria Carta, Aldo Di CarloGuido Palamara, Massimo Giuliani, Maria Elena Laguardia, Paolo Monini, Mauro Magnani, Fabrizio Ensoli, Barbara Ensoli

Research output: Contribution to journalArticle

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 7.5 μg, 15 μg or 30 μg 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.

Original languageEnglish
Pages (from-to)3306-3312
Number of pages7
JournalVaccine
Volume27
Issue number25-26
DOIs
Publication statusPublished - May 26 2009

Fingerprint

Human Immunodeficiency Virus tat Gene Products
Human immunodeficiency virus 1
HIV-1
Vaccines
vaccines
therapeutics
HIV
tat Gene Products
Th1 Cells
alum
proteins
endpoints
adjuvants
placebos
Anti-Idiotypic Antibodies
Therapeutics
T-lymphocytes
Placebos
immune response
Safety

Keywords

  • Clinical trial
  • HIV
  • Vaccination

ASJC Scopus subject areas

  • Immunology and Microbiology(all)
  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • veterinary(all)
  • Molecular Medicine

Cite this

Longo, O., Tripiciano, A., Fiorelli, V., Bellino, S., Scoglio, A., Collacchi, B., ... Ensoli, B. (2009). Phase I therapeutic trial of the HIV-1 Tat protein and long term follow-up. Vaccine, 27(25-26), 3306-3312. https://doi.org/10.1016/j.vaccine.2009.01.090

Phase I therapeutic trial of the HIV-1 Tat protein and long term follow-up. / Longo, Olimpia; Tripiciano, Antonella; Fiorelli, Valeria; Bellino, Stefania; Scoglio, Arianna; Collacchi, Barbara; Alvarez, Maria Josè Ruiz; Francavilla, Vittorio; Arancio, Angela; Paniccia, Giovanni; Lazzarin, Adriano; Tambussi, Giuseppe; Din, Chiara Tassan; Visintini, Raffaele; Narciso, Pasquale; Antinori, Andrea; D'Offizi, Gianpiero; Giulianelli, Marina; Carta, Maria; Di Carlo, Aldo; Palamara, Guido; Giuliani, Massimo; Laguardia, Maria Elena; Monini, Paolo; Magnani, Mauro; Ensoli, Fabrizio; Ensoli, Barbara.

In: Vaccine, Vol. 27, No. 25-26, 26.05.2009, p. 3306-3312.

Research output: Contribution to journalArticle

Longo, O, Tripiciano, A, Fiorelli, V, Bellino, S, Scoglio, A, Collacchi, B, Alvarez, MJR, Francavilla, V, Arancio, A, Paniccia, G, Lazzarin, A, Tambussi, G, Din, CT, Visintini, R, Narciso, P, Antinori, A, D'Offizi, G, Giulianelli, M, Carta, M, Di Carlo, A, Palamara, G, Giuliani, M, Laguardia, ME, Monini, P, Magnani, M, Ensoli, F & Ensoli, B 2009, 'Phase I therapeutic trial of the HIV-1 Tat protein and long term follow-up', Vaccine, vol. 27, no. 25-26, pp. 3306-3312. https://doi.org/10.1016/j.vaccine.2009.01.090
Longo O, Tripiciano A, Fiorelli V, Bellino S, Scoglio A, Collacchi B et al. Phase I therapeutic trial of the HIV-1 Tat protein and long term follow-up. Vaccine. 2009 May 26;27(25-26):3306-3312. https://doi.org/10.1016/j.vaccine.2009.01.090
Longo, Olimpia ; Tripiciano, Antonella ; Fiorelli, Valeria ; Bellino, Stefania ; Scoglio, Arianna ; Collacchi, Barbara ; Alvarez, Maria Josè Ruiz ; Francavilla, Vittorio ; Arancio, Angela ; Paniccia, Giovanni ; Lazzarin, Adriano ; Tambussi, Giuseppe ; Din, Chiara Tassan ; Visintini, Raffaele ; Narciso, Pasquale ; Antinori, Andrea ; D'Offizi, Gianpiero ; Giulianelli, Marina ; Carta, Maria ; Di Carlo, Aldo ; Palamara, Guido ; Giuliani, Massimo ; Laguardia, Maria Elena ; Monini, Paolo ; Magnani, Mauro ; Ensoli, Fabrizio ; Ensoli, Barbara. / Phase I therapeutic trial of the HIV-1 Tat protein and long term follow-up. In: Vaccine. 2009 ; Vol. 27, No. 25-26. pp. 3306-3312.
@article{37e76d854c714ac6b9a9e9477946b779,
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 7.5 μg, 15 μg or 30 μg 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.",
keywords = "Clinical trial, HIV, Vaccination",
author = "Olimpia Longo and Antonella Tripiciano and Valeria Fiorelli and Stefania Bellino and Arianna Scoglio and Barbara Collacchi and Alvarez, {Maria Jos{\`e} Ruiz} and Vittorio Francavilla and Angela Arancio and Giovanni Paniccia and Adriano Lazzarin and Giuseppe Tambussi and Din, {Chiara Tassan} and Raffaele Visintini and Pasquale Narciso and Andrea Antinori and Gianpiero D'Offizi and Marina Giulianelli and Maria Carta and {Di Carlo}, Aldo and Guido Palamara and Massimo Giuliani and Laguardia, {Maria Elena} and Paolo Monini and Mauro Magnani and Fabrizio Ensoli and Barbara Ensoli",
year = "2009",
month = "5",
day = "26",
doi = "10.1016/j.vaccine.2009.01.090",
language = "English",
volume = "27",
pages = "3306--3312",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "25-26",

}

TY - JOUR

T1 - Phase I therapeutic trial of the HIV-1 Tat protein and long term follow-up

AU - Longo, Olimpia

AU - Tripiciano, Antonella

AU - Fiorelli, Valeria

AU - Bellino, Stefania

AU - Scoglio, Arianna

AU - Collacchi, Barbara

AU - Alvarez, Maria Josè Ruiz

AU - Francavilla, Vittorio

AU - Arancio, Angela

AU - Paniccia, Giovanni

AU - Lazzarin, Adriano

AU - Tambussi, Giuseppe

AU - Din, Chiara Tassan

AU - Visintini, Raffaele

AU - Narciso, Pasquale

AU - Antinori, Andrea

AU - D'Offizi, Gianpiero

AU - Giulianelli, Marina

AU - Carta, Maria

AU - Di Carlo, Aldo

AU - Palamara, Guido

AU - Giuliani, Massimo

AU - Laguardia, Maria Elena

AU - Monini, Paolo

AU - Magnani, Mauro

AU - Ensoli, Fabrizio

AU - Ensoli, Barbara

PY - 2009/5/26

Y1 - 2009/5/26

N2 - 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 7.5 μg, 15 μg or 30 μg 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.

AB - 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 7.5 μg, 15 μg or 30 μg 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.

KW - Clinical trial

KW - HIV

KW - Vaccination

UR - http://www.scopus.com/inward/record.url?scp=67349268940&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=67349268940&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2009.01.090

DO - 10.1016/j.vaccine.2009.01.090

M3 - Article

C2 - 19208456

AN - SCOPUS:67349268940

VL - 27

SP - 3306

EP - 3312

JO - Vaccine

JF - Vaccine

SN - 0264-410X

IS - 25-26

ER -