When the World Health Organization (WHO) endorsed the use of malaria vaccines, it assumed other therapeutics would be needed to reduce the number of mosquito-borne transmitted disease.
Recent data from the WHO indicates Malaria remains a leading cause of mortality among children in Africa, and recent advances in control have stagnated.
The WHO Global Malaria Programme has recently initiated a bold initiative: utilizing monoclonal antibodies to prevent a poverty-related disease in low- and middle-income countries.
In an article published by The Lancet on September 23, 2025, researchers reported that a monoclonal antibody could prove a valuable treatment option, offering immediate, high-level protection over multiple months, a simplified dosing regimen, and consistent effectiveness, regardless of the recipient’s immunological background.
Researchers assessed the safety, pharmacokinetics, and protective efficacy of MAM01, a monoclonal antibody preferentially directed against the conserved Asn-Ala-Asn-Pro (NANP) central repeat region of circumsporozoite protein. This Gates Foundation-funded phase 1, dose-escalation, double-blind, placebo-controlled, adaptive trial was done at the Center for Vaccine Development and Global Health, University of Maryland, Baltimore, MD.
After controlled human malaria infection, six of six participants in the control group and 18 of 22 participants in the MAM01 group developed parasitaemia. None of the three participants in the 40 mg/kg intravenous dose group developed parasitaemia. Pharmacokinetic analysis revealed that serum MAM01 concentrations exceeding 88 μg/mL protected against malaria challenge.
MAM01 was found to be well-tolerated, met safety targets, and demonstrated clinical proof of principle by eliciting protection in malaria-naive adults using the controlled human malaria infection model. Additionally, progress driving down the cost of goods, coupled with dose selection within target populations, will dictate the feasibility of malaria monoclonal antibody deployment.
“How MAM01 would best be integrated into the current landscape of active and passive immunisation strategies, as well as other interventions against malaria, remains to be resolved,” they commented.
“One potential scenario might be seasonal prophylaxis in yearly rotation with other monoclonal antibodies to help prevent parasite escape mutants,” they added.
“Implementation of monoclonal antibodies in general will depend in large part on developments in large-scale production costs, which this new addition to the armamentarium might help to drive down.”
While this clinical trial process proceeds, Malaria vaccines are available in various African countries, but not in the United States.