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Double Blind Randomized Controlled Phase I Trial to Evaluate the Safety and Immunogenicity of WRAIR's MSP1 Candidate Malaria Vaccine (FMP1) Adjuvant in GSK Bio's AS02A vs. Rabies Vaccine in Semi-immune Adults in Bandiagara, Mali.
This study tested the safety of a new malaria vaccine in adults in Mali, West Africa, and measured the ability of the vaccine to stimulate antibodies directed against the malaria protein that the vaccine is based on. Forty adults were randomly assigned to get either the experimental malaria vaccine or a rabies vaccine, for comparison.
Details
| Lead sponsor | U.S. Army Medical Research and Development Command |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | 2003-07 |
| Completion | 2005-07 |
Conditions
- Malaria
Interventions
- FMP1/AS02A
- Imovax Rabies Vaccine
Primary outcomes
- Number of Participants With Solicited Adverse Events by Immunization and Type — Days 0, 1, 2, 3, 7, 30, 31, 32, 33, 37, 60, 61, 62, 63, 67
Number of participants with solicited adverse events by immunization and type (local, general and any) during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7.
Countries
Mali