1. Low-Dose Subcutaneous or Intravenous Monoclonal Antibody to Prevent Malaria
- Author
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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 T, 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, McDermott, Sandeep R, Narpala, Leonid, Serebryannyy, Mike, Castro, Rosa, Silva, Marjaan, Imam, Iris, Pittman, Somia P, Hickman, Andrew J, McDougal, Ashly E, Lukoskie, Jittawadee R, Murphy, Jason G, Gall, Kevin, Carlton, Patricia, Morgan, Ellie, Seo, Judy A, Stein, Sandra, Vazquez, Shinyi, Telscher, Edmund V, Capparelli, Emily E, Coates, John R, Mascola, Julie E, Ledgerwood, Lesia K, Dropulic, Robert A, Seder, and Benjamin, Clarkson
- Subjects
Adult ,Child, Preschool ,Plasmodium falciparum ,Animals ,Antibodies, Monoclonal ,Humans ,Administration, Intravenous ,General Medicine ,Malaria, Falciparum ,Administration, Cutaneous ,Child ,Parasitemia ,Malaria - Abstract
New approaches for the prevention and elimination of malaria, a leading cause of illness and death among infants and young children globally, are needed.We conducted a phase 1 clinical trial to assess the safety and pharmacokinetics of L9LS, a next-generation antimalarial monoclonal antibody, and its protective efficacy against controlled human malaria infection in healthy adults who had never had malaria or received a vaccine for malaria. The participants received L9LS either intravenously or subcutaneously at a dose of 1 mg, 5 mg, or 20 mg per kilogram of body weight. Within 2 to 6 weeks after the administration of L9LS, both the participants who received L9LS and the control participants underwent controlled human malaria infection in which they were exposed to mosquitoes carryingNo safety concerns were identified. L9LS had an estimated half-life of 56 days, and it had dose linearity, with the highest mean (±SD) maximum serum concentration (CIn 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.).
- Published
- 2023