FMP013

FMP013 is a recombinant protein-based malaria vaccine candidate developed to target *Plasmodium falciparum*. It consists of a nearly full-length, soluble circumsporozoite protein (CSP) antigen produced in *Escherichia coli*, formulated with the Army Liposomal Formulation containing QS-21 (ALFQ) as an adjuvant. Unlike the first-generation RTS,S/AS01 vaccine, which includes only major repeats and the C-terminal region of CSP, FMP013 incorporates additional N-terminal and junctional epitopes not present in RTS,S. This design aims to broaden immune responses against more regions of CSP, potentially improving efficacy and durability of protection. The ALFQ adjuvant contains 3D-PHAD™ (a TLR4 agonist) and QS-21 (an innate immunity modulator), both critical for optimal immunogenicity. Preclinical studies in mice and rhesus macaques demonstrated safety and robust antibody/T-cell responses; Phase 1 clinical trials have shown that FMP013/ALFQ is safe, well-tolerated, and immunogenic in humans[1][5][6][9].