Low-Dose Subcutaneous or Intravenous Monoclonal Antibody to Prevent Malaria

著者: Richard L Wu, Azza H. Idris, Nina M. Berkowitz, Myra Happe, Martin R. Gaudinski, Christian Buettner, Larisa Strom, Seemal F. Awan, LaSonji A. Holman, Floreliz Mendoza, Ingelise J. Gordon, Zonghui Hu, Andrezza Campos Chagas, Lawrence Wang, Lais Da Silva Pereira, Joseph R. Francica, Neville K. Kisalu, Barbara J. Flynn, Wei Shi, Wing‐Pui Kong, Sarah O’Connell, Sarah H. Plummer, Allison Beck, Adrian B. McDermott, Sandeep Narpala, Leonid Serebryannyy, Mike Castro, Rosa Silva, Marjaan Imam, Iris Pittman, Somia P. Hickman, Andrew J. McDougal, Ashly E. Lukoskie, Jittawadee Murphy, Jason G. Gall, Kevin Carlton, Patricia Morgan, Ellie Seo, Judy Stein, Sandra Vazquez, Shinyi Telscher, Edmund V. Capparelli, Emily E. Coates, John R. Mascola, Julie E. Ledgerwood, Lesia Dropulic, Robert A. Seder - New England Journal of Medicine, NEJM 2022 被引用: 124

BACKGROUND: New approaches for the prevention and elimination of malaria, a leading cause of illness and death among infants and young children globally, are needed. METHODS: (3D7 strain). RESULTS: was 164.8±31.1 in the participants who had received 5 mg per kilogram intravenously and 68.9±22.3 in those who had received 5 mg per kilogram subcutaneously. A total of 17 L9LS recipients and 6 control participants underwent controlled human malaria infection. Of the 17 participants who received a single dose of L9LS, 15 (88%) were protected after controlled human malaria infection. Parasitemia did not develop in any of the participants who received 5 or 20 mg per kilogram of intravenous L9LS. Parasitemia developed in 1 of 5 participants who received 1 mg per kilogram intravenously, 1 of 5 participants who received 5 mg per kilogram subcutaneously, and all 6 control participants through 21 days after the controlled human malaria infection. Protection conferred by L9LS was seen at serum concentrations as low as 9.2 μg per milliliter. CONCLUSIONS: In this small trial, L9LS administered intravenously or subcutaneously protected recipients against malaria after controlled infection, without evident safety concerns. (Funded by the National Institute of Allergy and Infectious Diseases; VRC 614 ClinicalTrials.gov number, NCT05019729.).