Delhi, New Delhi: According to a study, a novel malaria monoclonal antibody is safe, well-tolerated, and capable of providing protection to individuals who have never been exposed to the parasite that causes malaria.
Three persons without a history of malaria who received the maximum study dose did not have parasites in their bloodstream up to 26 weeks later, according to the results of the phase 1 randomized controlled trial of the investigational monoclonal antibody MAM01, which was published in the journal The Lancet Infectious Diseases.
A person who has never been exposed to the malaria parasite and hence lacks a natural immunity to the disease is referred to as "malaria-naive."
Despite the availability of new vaccines, their protective effectiveness is subpar. Plasmodium falciparum circumsporozoite protein monoclonal antibodies may make prevention easier, according to corresponding author Prof. Kirsten E. Lyke of the University of Maryland's Center for Vaccine Development and Global Health.
“MAM01 demonstrated clinical proof-of-principle by eliciting protection in malaria-naive adults using the controlled human malaria infection model, and it was well tolerated and met safety targets,” Lyke continued.
The World Health Organization (WHO) reports that in 2023, malaria killed 597,000 people and afflicted an estimated 263 million people globally. The greatest percentage of malaria-related deaths occur in children under the age of five, making them especially vulnerable.
From August 2023 to December 2024, the researchers randomly assigned 37 adults between the ages of 18 and 50 who had never had malaria to receive either a single dosage of MAM01 or a placebo.
After one or two doses, there were no significant side effects associated with the medication, and MAM01 administration was well tolerated.
Following infection, the blood of 18 out of 22 participants in the MAM01 group and 6 out of 6 participants in the control group had malaria parasites.
However, none of the three individuals in the intravenous dose group that received 40 mg/kg experienced parasitemia. Serum MAM01 concentrations over 88 microgram/mL were found to be protective against malaria challenge by pharmacokinetic analysis, according to the researchers.
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