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FMP2.1 is an investigational recombinant protein vaccine candidate developed for the prevention of malaria caused by *Plasmodium falciparum*. The vaccine is based on the Apical Membrane Antigen 1 (AMA1) derived from the 3D7 clone of the parasite, expressed in *Escherichia coli*. AMA1 is a microneme protein essential for the invasion of host erythrocytes and is also expressed in the sporozoite and liver stages of the *Plasmodium* life cycle. Developed by the Walter Reed Army Institute of Research (WRAIR) in collaboration with GSK, FMP2.1 is typically administered in combination with proprietary Adjuvant Systems, most notably AS02A (an oil-in-water emulsion with MPL and QS-21) and AS01B (a liposomal formulation with MPL and QS-21). While clinical trials in malaria-naïve adults and malaria-exposed children in endemic regions like Mali have shown the vaccine to be safe and highly immunogenic, Phase II efficacy results indicated that protection is primarily strain-specific, targeting parasites with AMA1 sequences identical or closely related to the 3D7 vaccine strain, with limited overall cross-protection against diverse field isolates.
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