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

Vaccine. 2009 May 26;27(25-26):3306-12. doi: 10.1016/j.vaccine.2009.01.090. Epub 2009 Feb 7.

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.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • AIDS Vaccines / adverse effects
  • AIDS Vaccines / therapeutic use
  • B-Lymphocytes / immunology
  • CD4 Lymphocyte Count
  • Double-Blind Method
  • Follow-Up Studies
  • HIV Antibodies / blood
  • HIV Infections / therapy*
  • Humans
  • Interferon-gamma / biosynthesis
  • Interleukin-4 / biosynthesis
  • Viral Load

Substances

  • AIDS Vaccines
  • HIV Antibodies
  • human immunodeficiency virus type 1 Tat vaccine
  • Interleukin-4
  • Interferon-gamma