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Intradermal injection of a Tat Oyi-based therapeutic HIV vaccine reduces of 1.5 log copies/mL the HIV RNA rebound median and no HIV DNA rebound following cART interruption in a phase I/II randomized controlled clinical trial.
- Source :
-
Retrovirology [Retrovirology] 2016 Apr 01; Vol. 13, pp. 21. Date of Electronic Publication: 2016 Apr 01. - Publication Year :
- 2016
-
Abstract
- Background: A Tat Oyi vaccine preparation was administered with informed consent to 48 long-term HIV-1 infected volunteers whose viral loads had been suppressed by antiretroviral therapy (cART). These volunteers were randomized in double-blind method into four groups (n = 12) that were injected intradermally with 0, 11, 33, or 99 µg of synthetic Tat Oyi proteins in buffer without adjuvant at times designated by month 0 (M0), M1 and M2, respectively. The volunteers then underwent a structured treatment interruption between M5 and M7.<br />Results: The primary outcomes of this phase I/IIa clinical trial were the safety and lowering the extent of HIV RNA rebound after cART interruption. Only one undesirable event possibly due to vaccination was observed. The 33 µg dose was most effective at lowering the extent of HIV RNA and DNA rebound (Mann and Whitney test, p = 0.07 and p = 0.001). Immune responses against Tat were increased at M5 and this correlated with a low HIV RNA rebound at M6 (p = 0.01).<br />Conclusion: This study suggests in vivo that extracellular Tat activates and protects HIV infected cells. The Tat Oyi vaccine in association with cART may provide an efficient means of controlling the HIV-infected cell reservoir.
- Subjects :
- AIDS Vaccines administration & dosage
Adult
DNA, Viral blood
Double-Blind Method
Female
Humans
Injections, Intradermal
Male
Middle Aged
RNA, Viral blood
Treatment Outcome
AIDS Vaccines immunology
Anti-Retroviral Agents therapeutic use
HIV Infections therapy
HIV-1 immunology
Viral Load
tat Gene Products, Human Immunodeficiency Virus immunology
Subjects
Details
- Language :
- English
- ISSN :
- 1742-4690
- Volume :
- 13
- Database :
- MEDLINE
- Journal :
- Retrovirology
- Publication Type :
- Academic Journal
- Accession number :
- 27036656
- Full Text :
- https://doi.org/10.1186/s12977-016-0251-3