drugset / Trial / NCT00073216
Safety of and Immune Response to a Combination HIV Vaccine Regimen in HIV Uninfected Adults
RandomizedFactorialPrevention
Summary
To prevent HIV infection, a vaccine that produces strong HIV-specific humoral (B-cell) and cellular (T-cell) immune system responses is desirable. The purpose of this study is to test the safety of and immune response to a novel combination HIV vaccine in HIV uninfected adults. This study will also test the safety of and immune response to a protein vaccine given alone.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- 2007-09
Publications
- Background Malkevitch NV, Robert-Guroff M. A call for replicating vector prime-protein boost strategies in HIV vaccine design. Expert Rev Vaccines. 2004 Aug;3(4 Suppl):S105-17. doi: 10.1586/14760584.3.4.s105.
- Background O'Hagan D, Singh M, Ugozzoli M, Wild C, Barnett S, Chen M, Schaefer M, Doe B, Otten GR, Ulmer JB. Induction of potent immune responses by cationic microparticles with adsorbed human immunodeficiency virus DNA vaccines. J Virol. 2001 Oct;75(19):9037-43. doi: 10.1128/JVI.75.19.9037-9043.2001.
- Background O'Hagan DT, Ugozzoli M, Barackman J, Singh M, Kazzaz J, Higgins K, Vancott TC, Ott G. Microparticles in MF59, a potent adjuvant combination for a recombinant protein vaccine against HIV-1. Vaccine. 2000 Mar 6;18(17):1793-801. doi: 10.1016/s0264-410x(99)00522-8.
- Background Slobod KS, Bonsignori M, Brown SA, Zhan X, Stambas J, Hurwitz JL. HIV vaccines: brief review and discussion of future directions. Expert Rev Vaccines. 2005 Jun;4(3):305-13. doi: 10.1586/14760584.4.3.305.
- Background Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. doi: 10.2174/1389450043490686.
- Spearman P, Lally MA, Elizaga M, Montefiori D, Tomaras GD, McElrath MJ, Hural J, De Rosa SC, Sato A, Huang Y, Frey SE, Sato P, Donnelly J, Barnett S, Corey LJ; HIV Vaccine Trials Network of NIAID. A trimeric, V2-deleted HIV-1 envelope glycoprotein vaccine elicits potent neutralizing antibodies but limited breadth of neutralization in human volunteers. J Infect Dis. 2011 Apr 15;203(8):1165-73. doi: 10.1093/infdis/jiq175.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clade B Recombinant, Oligomeric gp140/MF59 Adjuvant | Vaccine | — | — |
| Subject | Clade B gag DNA/PLG and env DNA/PLG Microparticles | Vaccine | 250 ug | Intramuscular |
| Subject | Clade B gag DNA/PLG and env DNA/PLG Microparticles | Vaccine | 500 ug | Intramuscular |
| Subject | Clade B gag DNA/PLG and env DNA/PLG Microparticles | Vaccine | 1000 ug | Intramuscular |