drugset / Trial / NCT00075049
Safety and Efficacy Study of RTS,S AS02A/AS01B Vaccine to Prevent Malaria
Phase 1/2
Completed
104 enrolled
U.S. Army Medical Research and Development Command
GlaxoSmithKline · collabWalter Reed Army Institute of Research (WRAIR) · collab
RandomizedSingle-groupDouble-blindPrevention
Summary
This is a double blinded study where 2 test vaccines will be evaluated to see if they protect persons who have never had malaria against malaria infection when bitten by mosquitoes.
Timeline
- Start
- 2003-12
- Primary completion
- 2006-01
- Completion
- 2006-01
Publications
- Results Stewart VA, McGrath SM, Walsh DS, Davis S, Hess AS, Ware LA, Kester KE, Cummings JF, Burge JR, Voss G, Delchambre M, Garcon N, Tang DB, Cohen JD, Heppner DG Jr. Pre-clinical evaluation of new adjuvant formulations to improve the immunogenicity of the malaria vaccine RTS,S/AS02A. Vaccine. 2006 Oct 30;24(42-43):6483-92. doi: 10.1016/j.vaccine.2006.06.033. Epub 2006 Jul 3.
- Kurtovic L, Atre T, Feng G, Wines BD, Chan JA, Boyle MJ, Drew DR, Hogarth PM, Fowkes FJI, Bergmann-Leitner ES, Beeson JG. Multifunctional Antibodies Are Induced by the RTS,S Malaria Vaccine and Associated With Protection in a Phase 1/2a Trial. J Infect Dis. 2021 Oct 13;224(7):1128-1138. doi: 10.1093/infdis/jiaa144.
- Kester KE, Cummings JF, Ofori-Anyinam O, Ockenhouse CF, Krzych U, Moris P, Schwenk R, Nielsen RA, Debebe Z, Pinelis E, Juompan L, Williams J, Dowler M, Stewart VA, Wirtz RA, Dubois MC, Lievens M, Cohen J, Ballou WR, Heppner DG Jr; RTS,S Vaccine Evaluation Group. Randomized, double-blind, phase 2a trial of falciparum malaria vaccines RTS,S/AS01B and RTS,S/AS02A in malaria-naive adults: safety, efficacy, and immunologic associates of protection. J Infect Dis. 2009 Aug 1;200(3):337-46. doi: 10.1086/600120.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RTS,S | Vaccine | — | — |