drugset / Trial / NCT00197054
Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults.
Phase 2
Completed
255 enrolled
U.S. Army Medical Research and Development Command
GlaxoSmithKline · collabWalter Reed Army Institute of Research (WRAIR) · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The candidate malaria vaccine RTS,S/AS02A developed by GSK Biologicals demonstrated 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease. As a potential improvement to RTS,S/AS02A, another candidate vaccine RTS,S/AS01B is being developed in parallel in collaboration with the Walter Reed Army Institute of Research (WRAIR). This study will be the first administration of the RTS,S/AS01B vaccine to the African adults to establish safety and immunogenicity in this population. Preliminary indication of vaccine efficacy with this adjuvant will be established by monitoring the time to the first infection with Plasmodium falciparum.
Timeline
- Start
- 2005-07
- Primary completion
- 2006-09
- Completion
- 2006-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RTS, S/AS01B | Unknown | 0.5 ml | Intramuscular |
| Subject | RTS, S/AS02A | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Rabies vaccine | Vaccine | 1 ml | Intramuscular |