drugset / Trial / NCT00121758
AIDS Vaccine Study Comparing Immunogenicity and Safety of 3 Doses of Lipopeptides Versus Placebo in Non Infected HIV Volunteers
Phase 2
Completed
156 enrolled
French National Agency for Research on AIDS and Viral Hepatitis
Aventis Pharmaceuticals · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This study will test the safety and immune response to an experimental HIV vaccine, LIPO-5, in healthy volunteers. LIPO-5 contains 5 lipopeptides from gag, nef and pol corresponding to more than 50 epitopes. LIPO-5 has been shown to be immunogenic and well tolerated in a first phase I trial in non-HIV infected volunteers. Lower doses of each peptide could have a similar immunogenicity.
Timeline
- Start
- 2004-09
- Primary completion
- 2007-11
- Completion
- 2007-12
Publications
- Richert L, Hue S, Hocini H, Raimbault M, Lacabaratz C, Surenaud M, Wiedemann A, Tisserand P, Durier C, Salmon D, Lelievre JD, Chene G, Thiebaut R, Levy Y; ANRS Vaccine Network/Vaccine Research Institute. Cytokine and gene transcription profiles of immune responses elicited by HIV lipopeptide vaccine in HIV-negative volunteers. AIDS. 2013 Jun 1;27(9):1421-31. doi: 10.1097/QAD.0b013e32835f5b60.
- Salmon-Ceron D, Durier C, Desaint C, Cuzin L, Surenaud M, Hamouda NB, Lelievre JD, Bonnet B, Pialoux G, Poizot-Martin I, Aboulker JP, Levy Y, Launay O; ANRS VAC18 trial group. Immunogenicity and safety of an HIV-1 lipopeptide vaccine in healthy adults: a phase 2 placebo-controlled ANRS trial. AIDS. 2010 Sep 10;24(14):2211-23. doi: 10.1097/QAD.0b013e32833ce566.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LIPO-5 | Vaccine | 50 ug | — |
| Subject | LIPO-5 | Vaccine | 150 ug | — |
| Subject | LIPO-5 | Vaccine | 500 ug | — |