Safety and Efficacy of a Monoclonal Antibody against Malaria in Mali.
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Kayentao Kassoum, Ongoiba Aissata, Preston Anne C, Healy Sara A, Doumbo Safiatou, Doumtabe Didier, Traore Abdrahamane, Traore Hamadi, Djiguiba Adama, Li Shanping, Peterson Mary E, Telscher Shinyi, Idris Azza H, Kisalu Neville K, Carlton Kevin, Serebryannyy Leonid, Narpala Sandeep, McDermott Adrian B, Gaudinski Martin, Traore Siriman, Cisse Hamidou, Keita Mamadou, Skinner Jeff, Hu Zonghui, Zéguimé Amatigué, Ouattara Adama, Doucoure M'Bouye, Dolo Amagana, Djimdé Abdoulaye, Traore Boubacar, Seder Robert A, Crompton Peter D, Mali Malaria mAb Trial Team
Аннотация
METHODS: We conducted a phase 2 trial to assess the safety and efficacy of a single intravenous infusion of CIS43LS against P. falciparum infection in healthy adults in Mali over a 6-month malaria season. In Part A, safety was assessed at three escalating dose levels. In Part B, participants were randomly assigned (in a 1:1:1 ratio) to receive 10 mg of CIS43LS per kilogram of body weight, 40 mg of CIS43LS per kilogram, or placebo. The primary efficacy end point, assessed in a time-to-event analysis, was the first P. falciparum infection detected on blood-smear examination, which was performed at least every 2 weeks for 24 weeks. At enrollment, all the participants received artemether-lumefantrine to clear possible P. falciparum infection.
RESULTS: In Part B, 330 adults underwent randomization; 110 were assigned to each trial group. The risk of moderate headache was 3.3 times as high with 40 mg of CIS43LS per kilogram as with placebo. P. falciparum infections were detected on blood-smear examination in 39 participants (35.5%) who received 10 mg of CIS43LS per kilogram, 20 (18.2%) who received 40 mg of CIS43LS per kilogram, and 86 (78.2%) who received placebo. At 6 months, the efficacy of 40 mg of CIS43LS per kilogram as compared with placebo was 88.2% (adjusted 95% confidence interval [CI], 79.3 to 93.3; P<0.001), and the efficacy of 10 mg of CIS43LS per kilogram as compared with placebo was 75.0% (adjusted 95% CI, 61.0 to 84.0; P<0.001).
CONCLUSIONS: CIS43LS was protective against P. falciparum infection over a 6-month malaria season in Mali without evident safety concerns. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT04329104.).