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The global impact of malaria remains substantial and new approaches to control are needed, especially given the emergence of insecticide-resistant mosquitoes and increasingly drug-resistant Plasmodium strains. A recent phase 1 study found that a monoclonal antibody, CIS43LS — which targets a conserved epitope of the P. falciparum circumsporozoite protein — effectively prevented controlled malaria infection in healthy volunteers (NEJM JW Infect Dis Oct 2021 and N Engl J Med 2021; 385:803). Investigators have now extended this work in a two-part, phase 2 trial in a region of Mali endemic for P. falciparum.
In an initial safety study, 18 subjects were randomized to receive intravenous infusions of 5 mg/kg, 10 mg/kg, or 40 mg/kg of CIS43LS with …