Safety and Efficacy of a Monoclonal Antibody against Malaria in Mali
Kassoum Kayentao, Aïssata Ongoïba, Anne C Preston, Sara A. Healy, Safiatou Doumbo, Didier Doumtabé, Abdrahamane Traoré, Hamadi Traore, Adama Djiguiba, Shanping Li, Mary Peterson, Shinyi Telscher, Azza H. Idris, Neville K. Kisalu, Kevin Carlton, Leonid Serebryannyy, Sandeep Narpala, Adrian B. McDermott, Martin R. Gaudinski, Siriman Traoré, Hamidou Cisse, Mamadou Keita, Jeff Skinner, Zonghui Hu, Amatigué Zéguimé, Adama Ouattara, M’Bouye Doucoure, Amagana Dolo, Abdoulaye Djimdé, Boubacar Traoré, Robert A. Seder, Peter D. Crompton
Abstract
BACKGROUND: infection in a region in which the infection is endemic is unknown. METHODS: infection. RESULTS: 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: 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.).