Dose-ranging Study to Evaluate the Safety & Immunogenicity of a HIV Vaccine 732461 in Healthy HIV Seronegative Volunteers

Summary

GSK has constructed a new HIV immunogen comprised of conserved parts of the HIV virus (gag, pol and nef). The principal objectives of this study are to evaluate the reactogenicity and safety of this candidate vaccine with or without a GSK proprietary adjuvant system at three different doses and to evaluate the CD4+ T-cell response in terms of proportion of responders to the antigens two weeks after the second vaccination.

Timeline

Start

2007-02-20

Primary completion

2008-06-13

Completion

2008-06-13

Publications

• Leroux-Roels G, Bourguignon P, Willekens J, Janssens M, Clement F, Didierlaurent AM, Fissette L, Roman F, Boutriau D. Immunogenicity and safety of a booster dose of an investigational adjuvanted polyprotein HIV-1 vaccine in healthy adults and effect of administration of chloroquine. Clin Vaccine Immunol. 2014 Mar;21(3):302-11. doi: 10.1128/CVI.00617-13. Epub 2014 Jan 3.
• Van Braeckel E, Koutsoukos M, Bourguignon P, Clement F, McNally L, Leroux-Roels G. Vaccine-induced HIV seropositivity: a problem on the rise. J Clin Virol. 2011 Apr;50(4):334-7. doi: 10.1016/j.jcv.2011.01.003.
• Van Braeckel E, Bourguignon P, Koutsoukos M, Clement F, Janssens M, Carletti I, Collard A, Demoitie MA, Voss G, Leroux-Roels G, McNally L. An adjuvanted polyprotein HIV-1 vaccine induces polyfunctional cross-reactive CD4+ T cell responses in seronegative volunteers. Clin Infect Dis. 2011 Feb 15;52(4):522-31. doi: 10.1093/cid/ciq160. Epub 2011 Jan 5.

Drugs

Indications