Dr. Kirsten Lyke with research volunteer who was uncovered to infective mosquitoes carrying malaria parasite. Credit score: College of Maryland Faculty of Drugs
Malaria stays one of many main causes of dying amongst youngsters in sub-Saharan Africa, claiming greater than 600,000 lives annually worldwide with restricted efficacy in presently accessible therapies and vaccines. Now a brand new early-stage scientific trial discovered {that a} novel monoclonal antibody supplied dose-dependent full safety in opposition to the malaria parasite with minimal negative effects.
Researchers on the College of Maryland Faculty of Drugs’s Middle for Vaccine Improvement and International Well being (CVD) carried out the trial in wholesome volunteers who had been uncovered, in a managed method, to bites, from mosquitoes contaminated with the malaria parasite.
Outcomes had been lately printed in The Lancet Infectious Illnesses. The researchers carried out the trial in collaboration with the Gates Medical Analysis Institute.
“Despite major advances, malaria continues to devastate families and communities across Africa,” stated research lead creator Kirsten E. Lyke, MD, Professor of Drugs at UM Faculty of Drugs and principal investigator at CVD. “This new monoclonal antibody could transform how we prevent malaria in young children and pregnant women. Unlike vaccines that may require multiple doses or boosters, a single injection of a long-acting antibody could provide immediate, months-long protection. It’s a fundamentally different way to stop infection before it starts.”
Monoclonal antibodies (mAbs) are laboratory-made protein clones that mimic the physique’s pure immune defenses. MAM01 targets a extremely conserved area of the Plasmodium falciparum circumsporozoite protein—a protein on the parasite’s outer floor—to dam an infection earlier than it reaches the bloodstream.
The Section 1, double-blind, placebo-controlled trial enrolled 38 wholesome adults aged 18 to 50 with no prior malaria publicity. Individuals obtained one dose of MAM01 or a placebo, and had been then uncovered to mosquitoes carrying malaria, a number of months after dosing. This was accomplished beneath fastidiously managed circumstances referred to as a problem research. After the malaria problem, not one of the individuals who obtained the best dose of the monoclonal antibody developed an infection, in comparison with all of the individuals within the placebo group.
“These early results suggest that this monoclonal antibody can provide reliable protection against malaria, which continues to disproportionately affect children who live in low and middle-income countries,” stated research co-author Matthew B. Laurens, MD, MPH, Professor of Pediatrics and Director of the Malaria Worldwide Medical Trials Unit at CVD. “This is an important proof-of-concept for the field and a step forward for health equity.”
No treatment-related severe hostile occasions occurred.
“The CVD research team is now exploring optimized dosing and cost-reduction strategies to make monoclonal antibody–based prevention feasible in malaria-endemic regions,” stated UM Faculty of Drugs Dean Mark T. Gladwin, MD, who can be the Vice President for Medical Affairs on the College of Maryland, Baltimore (UMB), and the John Z. and Akiko Ok. Bowers Distinguished Professor. “Testing of this preventive treatment has already started in young children in Uganda, based on the promising results from the first trial conducted here.”
Added James Campbell, MD, MS, Interim Director of the Middle for Vaccine Improvement and International Well being: “This study represents real hope for millions of children at risk. CVD has been a global leader in malaria research for more than 50 years, and these findings advance our mission to eliminate this disease through innovative science.”
Extra data:
Kirsten E Lyke et al, Human monoclonal antibody MAM01 for cover in opposition to malaria in adults within the USA: a first-in-human, section 1, dose-escalation, double-blind, placebo-controlled, adaptive trial, The Lancet Infectious Illnesses (2025). DOI: 10.1016/s1473-3099(25)00481-5
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New monoclonal antibody prevents malaria an infection in early scientific trial (2025, October 18)
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