drugset / Trial / NCT00666380
A Study to Determine the Effects of an Investigational Malaria Vaccine Given to Adults Living in the United States and Thereafter to Adults Living in Kenya
Phase 1
Completed
26 enrolled
U.S. Army Medical Research and Development Command
GlaxoSmithKline · collabKenya Medical Research Institute · collabUnited States Agency for International Development (USAID) · collabWalter Reed Army Institute of Research (WRAIR) · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to determine whether an investigational malaria vaccine is safe and induces an immune response against malaria when tested in adults living in the United States.
Timeline
- Start
- 2008-04
- Primary completion
- 2008-12
- Completion
- 2009-06
Publications
- Bashir IM, Otsyula N, Awinda G, Spring M, Schneider P, Waitumbi JN. Comparison of PfHRP-2/pLDH ELISA, qPCR and microscopy for the detection of plasmodium events and prediction of sick visits during a malaria vaccine study. PLoS One. 2013;8(3):e56828. doi: 10.1371/journal.pone.0056828. Epub 2013 Mar 15.
- Otsyula N, Angov E, Bergmann-Leitner E, Koech M, Khan F, Bennett J, Otieno L, Cummings J, Andagalu B, Tosh D, Waitumbi J, Richie N, Shi M, Miller L, Otieno W, Otieno GA, Ware L, House B, Godeaux O, Dubois MC, Ogutu B, Ballou WR, Soisson L, Diggs C, Cohen J, Polhemus M, Heppner DG Jr, Ockenhouse CF, Spring MD. Results from tandem Phase 1 studies evaluating the safety, reactogenicity and immunogenicity of the vaccine candidate antigen Plasmodium falciparum FVO merozoite surface protein-1 (MSP1(42)) administered intramuscularly with adjuvant system AS01. Malar J. 2013 Jan 23;12:29. doi: 10.1186/1475-2875-12-29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Plasmodium falciparum Malaria Protein 010 (FMP010) | Protein / enzyme biologic | 10 ug | Intramuscular |
| Subject | Plasmodium falciparum Malaria Protein 010 (FMP010) | Protein / enzyme biologic | 50 ug | Intramuscular |