Anti-malaria MAb in Kenyan Children

Summary

The purpose of this study is to evaluate the safety and tolerability of one-time subcutaneous (SC) administration of monoclonal antibody (MAb) L9LS in healthy Kenyan children aged 5 months to 10 years, as well as the protective efficacy of one or two doses of L9LS against naturally occurring Plasmodium falciparum (Pf) infection among Kenyan children aged 5 to 59 months at enrollment, in a setting of perennial high transmission.

Timeline

Start

2022-09-14

Primary completion

2024-06-02

Completion

2024-06-02

Publications

• Steinhardt LC, Kwambai TK, Oneko M, Ouma E, Njoroge R, Callier V, Hu Z, Gutman JR, Yego R, Otieno K, Onoka K, Otieno L, Oduol K, Serebryannyy L, Lin BC, Adams W, Hickman S, Preston AC, Carlton K, Holdsworth M, Xiao Y, O Ter Kuile F, Odongo W, Murphy SC, Tran TM, Kariuki S, Crompton PD, Seder RA; Kenya Malaria mAb Trials Team. Safety and efficacy of the monoclonal antibody L9LS for malaria prevention in children exposed to perennial malaria transmission in Kenya: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2026 Apr 25;407(10539):1614-1625. doi: 10.1016/S0140-6736(26)00258-8.

Drugs

Indications