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Sponsors and Collaborators: |
Walter Reed Army Institute of Research (WRAIR) GlaxoSmithKline The PATH Malaria Vaccine Initiative (MVI) |
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Information provided by: | Walter Reed Army Institute of Research (WRAIR) |
ClinicalTrials.gov Identifier: | NCT00312702 |
Purpose of the study is to determine whether LSA-1/AS02A combination malaria vaccine is effective at preventing malaria.
Condition | Intervention | Phase |
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Malaria Plasmodium Falciparum Malaria |
Biological: Falciparum Malaria Protein 1 with AS02A adjuvant |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/IIa Controlled Study of the Safety, Immunogenicity and Preliminary Efficacy of FMP011/AS02A Candidate Malaria Vaccine in Malaria-Naive Adults Living in the United States |
Estimated Enrollment: | 36 |
Study Start Date: | April 2006 |
Study Completion Date: | April 2007 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Walter Reed Army Institute of Research | |
Silver Spring, Maryland, United States, 20910 |
Principal Investigator: | James F Cummings, MD | Walter Reed Army Institute of Research (WRAIR) |
Study ID Numbers: | WRAIR 1249, HSRRB A-13732 |
Study First Received: | April 6, 2006 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00312702 |
Health Authority: | United States: Food and Drug Administration |
Vaccine Malaria Liver Stage Antigen-1 |
Falciparum Malaria Protein-1 AS02A adjuvant |
Protozoan Infections Parasitic Diseases Malaria Malaria, Falciparum |
Coccidiosis |