New Delhi, Sep 25 A new malaria monoclonal antibody is safe, well-tolerated, and can elicit protection in people with no prior exposure to the malaria-causing parasite, according to a study.
The phase 1 randomised controlled trial of the experimental monoclonal antibody MAM01, published in the journal The Lancet Infectious Diseases, showed that of the three malaria-naive adults given the highest study dose, none had parasites in their bloodstream up to 26 weeks later.
"Malaria-naive" refers to an individual who has never been exposed to the malaria parasite and therefore has no natural immunity to the disease.
“Although new vaccines are available, protective efficacy is not optimum. Monoclonal antibodies targeting the Plasmodium falciparum circumsporozoite protein have the potential to simplify prevention,” said corresponding author Prof Kirsten E Lyke, Center for Vaccine Development and Global Health, at the University of Maryland.
“MAM01 was well tolerated, met safety targets, and showed clinical proof-of-principle by eliciting protection in malaria-naive adults using the controlled human malaria infection model," Lyke added.
According to data from the World Health Organization (WHO), malaria affected an estimated 263 million people worldwide and caused 597,000 deaths in 2023. Children under the age of five are particularly vulnerable, accounting for the highest proportion of malaria-related deaths.
For the study, the team randomly assigned 37 malaria-naïve adults aged 18 to 50 years to receive a single dose of MAM01 or a placebo from August 2023 to December 2024.
MAM01 administration was well tolerated, and no treatment-related serious adverse events occurred after one or two doses.
After infection, 6 of 6 participants in the control group and 18 of 22 participants in the MAM01 group had malaria parasites in their blood.
But “none of the three participants in the 40 mg/kg intravenous dose group developed parasitaemia. Pharmacokinetic analysis showed that serum MAM01 concentrations greater than 88 microgram/mL protected against malaria challenge,” the researchers said.
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