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Clinical Trials associated with Malaria vaccine (FMP012) (Walter Reed Army Institute of Research/US Army Medical Research and Materiel Command)Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) Open-label Dose Safety, Reactogenicity, Immunogenicity, and Efficacy of the Vaccine Candidate Plasmodium Falciparum Malaria Protein (FMP012), Administered Intramuscularly With AS01B Adjuvant System in Healthy Malaria-Naïve Adults
The proposed study is a Phase 1 study with controlled human malaria infection (CHMI) designed primarily to evaluate the safety of the FMP012 combined with AS01B adjuvant system. AS01B is a proprietary current good manufacturing practices (cGMP) grade adjuvant manufactured by GlaxoSmithKline (GSK) Biologicals. It is a formulation based on liposomes mixed with the immunostimulants monophosphoryl lipid (MPL) and Quillaja saponaria (QS)-21. The immunogenicity and efficacy of this new candidate vaccine will be evaluated in addition to safety.
Phase 1 Study With the Vaccine Candidate Plasmodium Falciparum Malaria Protein (FMP012), an E.Coli-expressed Cell-Traversal Protein, Administered Intramuscularly in Healthy Malaria-Naive Adults
Malaria has remained a major concern for the US military. During World War II, malaria was the leading cause of disease and non-battle injury with 500-700 men infected per day, resulting in 24,000 malaria-related casualties.(10) Currently, the methods used for protecting troops against malaria are insecticidal nets, clothing, and antimalarial treatment. To be effective, these methods must be self-administered and be used consistently, often unattainable in field or combat situations. The United States Army Medical Research and Development Command (USAMRMC), through the United States Army Medical Materiel Development Activity (USAMMDA) and the Walter Reed Army Institute of Research (WRAIR) are actively pursuing the development of an effective vaccine against P. falciparum malaria; development of such a vaccine is a high priority for the US military and other individuals who travel to endemic regions, and is equally important to populations residing in those areas.
A Phase 1 study using FMP012, a recombinant E.coli expressed malaria protein (CelTOS) vaccine will
assess the safety and reactogenicity of candidate P. falciparum malaria vaccine FMP012/GLA-SE
Secondary:
measure the humoral immune response to FMP012/GLA-SE using enzyme-linked immunosorbent assay (ELISA)
assess the protective efficacy of FMP012/GLA-SE against a P. falciparum sporozoite challenge.
100 Clinical Results associated with Malaria vaccine (FMP012) (Walter Reed Army Institute of Research/US Army Medical Research and Materiel Command)
100 Translational Medicine associated with Malaria vaccine (FMP012) (Walter Reed Army Institute of Research/US Army Medical Research and Materiel Command)
100 Patents (Medical) associated with Malaria vaccine (FMP012) (Walter Reed Army Institute of Research/US Army Medical Research and Materiel Command)
100 Deals associated with Malaria vaccine (FMP012) (Walter Reed Army Institute of Research/US Army Medical Research and Materiel Command)