drugset / Trial / NCT00223990
Double-blind, Randomized, Controlled Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine
Phase 2
Completed
400 enrolled
U.S. Army Medical Research and Development Command
GlaxoSmithKline · collabKenya Medical Research Institute · collabThe PATH Malaria Vaccine Initiative (MVI) · collabUnited States Agency for International Development (USAID) · collabWalter Reed Army Institute of Research (WRAIR) · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas. This vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum. Prior to the start of this study, FMP1/AS02A had been given to approximately 60 malaria-naïve adults and 40 adults and 90 children living in malaria-endemic regions. This study will investigate whether the candidate vaccine prevents malaria disease for 6 months post-vaccination. One half of the enrolled subjects will receive FMP1/AS02A and the other half rabies vaccine (RabAvert).
Timeline
- Start
- 2005-04-08
- Primary completion
- 2006-04-26
- Completion
- 2007-06
Publications
- Background Pichyangkul S, Gettayacamin M, Miller RS, Lyon JA, Angov E, Tongtawe P, Ruble DL, Heppner DG Jr, Kester KE, Ballou WR, Diggs CL, Voss G, Cohen JD, Walsh DS. Pre-clinical evaluation of the malaria vaccine candidate P. falciparum MSP1(42) formulated with novel adjuvants or with alum. Vaccine. 2004 Sep 28;22(29-30):3831-40. doi: 10.1016/j.vaccine.2004.07.023.
- Background Angov E, Aufiero BM, Turgeon AM, Van Handenhove M, Ockenhouse CF, Kester KE, Walsh DS, McBride JS, Dubois MC, Cohen J, Haynes JD, Eckels KH, Heppner DG, Ballou WR, Diggs CL, Lyon JA. Development and pre-clinical analysis of a Plasmodium falciparum Merozoite Surface Protein-1(42) malaria vaccine. Mol Biochem Parasitol. 2003 May;128(2):195-204. doi: 10.1016/s0166-6851(03)00077-x.
- Ogutu BR, Apollo OJ, McKinney D, Okoth W, Siangla J, Dubovsky F, Tucker K, Waitumbi JN, Diggs C, Wittes J, Malkin E, Leach A, Soisson LA, Milman JB, Otieno L, Holland CA, Polhemus M, Remich SA, Ockenhouse CF, Cohen J, Ballou WR, Martin SK, Angov E, Stewart VA, Lyon JA, Heppner DG, Withers MR; MSP-1 Malaria Vaccine Working Group. Blood stage malaria vaccine eliciting high antigen-specific antibody concentrations confers no protection to young children in Western Kenya. PLoS One. 2009;4(3):e4708. doi: 10.1371/journal.pone.0004708. Epub 2009 Mar 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FMP1/AS02A | Vaccine | 50 ug | Intramuscular |
| Comparator | Rabies vaccine | Vaccine | — | Intramuscular |