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Sponsors and Collaborators: |
U.S. Army Office of the Surgeon General Kenya Medical Research Institute Walter Reed Army Institute of Research (WRAIR) The PATH Malaria Vaccine Initiative United States Agency for International Development (USAID) GlaxoSmithKline |
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Information provided by: | Walter Reed Army Institute of Research (WRAIR) |
ClinicalTrials.gov Identifier: | NCT00317473 |
To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed children living in western Kenya and aged 12-47 months
Condition | Intervention | Phase |
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Plasmodium Falciparum Malaria |
Biological: MSP-1 (FMP-1) with AS02A vs Imovax rabies vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | Double-Blind,Randomized,Controlled,Dose Escalation Phase 1 Trial in 12-47 Month Old Children in Western Kenya to Evaluate the Safety and Immunogenicity of WRAIR’s MSP-1(FMP1) Malaria Vaccine Adjuvanted in GSK's AS02A Versus Rabies Vaccine. |
Estimated Enrollment: | 135 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | September 2004 |
The study evaluates the safety, reactogenicity, and immunogenicity of an investigational malaria vaccine. The design is of an age-stratified phase Ib, double-blind, randomized, controlled, dose-escalation trial. Children were recruited into one of three cohorts (dosage groups) and randomized in 2:1 fashion to receive either the test product or a comparator. The setting is a rural population in Kombewa Division, western Kenya. The participants are 135 children aged 12-47 months and their mothers. The interventions are 10, 25 or 50 g of the falciparum malaria protein 1 (FMP1) formulated in 100, 250 and 500 L respectively of AS02A, or a comparator (Imovax® rabies vaccine). Outcome measures are safety and reactogenicity parameters and assessment of adverse events during solicited periods (7 days) and unsolicited periods (30 days) after each vaccination. Serious adverse events were monitored for 6 months after the last vaccination.
Ages Eligible for Study: | 12 Months to 47 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Kenya, Nyanza Province | |
Walter Reed Project Kombewa Clinic | |
Kombewa, Nyanza Province, Kenya |
Principal Investigator: | Mark R. Withers, M.D., MPH | USAMRU-K |
Study ID Numbers: | WRAIR 1030, HSRRB Log No. A-12094, KEMRI SSC No. 761, HSPC No. HS171 |
Study First Received: | April 20, 2006 |
Last Updated: | April 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00317473 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Vaccine Phase 1 Plasmodium falciparum Malaria Merozoite surface protein-1 |
MSP-1 Falciparum malaria protein 1 FMP-1 AS02A |
Protozoan Infections Rabies Parasitic Diseases Malaria Malaria, Falciparum |
Protozoan Infections Coccidiosis Parasitic Diseases Malaria Malaria, Falciparum |