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In a significant stride towards combating malaria, researchers have reported promising results from a mid-stage clinical trial conducted in Mali, where a single injected dose of an experimental malaria monoclonal antibody demonstrated 77% effectiveness against the disease in children during the country’s six-month malaria season. The trial, assessing an investigational monoclonal antibody developed by scientists at the National Institutes of Health (NIH), has generated optimism for addressing an unmet public health need.
Published in The New England Journal of Medicine, the study’s findings underscore the potential of a long-acting monoclonal antibody to provide rapid and high-level protection against malaria, particularly in vulnerable populations such as children in malaria-endemic regions.
Dr. Jeanne Marrazzo, director of the National Institute of Allergy and Infectious Diseases, part of NIH, emphasized the significance of this breakthrough, stating, “A long-acting monoclonal antibody delivered at a single health care visit that rapidly provides high-level protection against malaria in these vulnerable populations would fulfill an unmet public health need.”
The clinical trial evaluated two dose levels, with the 300mg-dose group demonstrating 77% protective efficacy against symptomatic malaria, while the 150mg-dose group showed 67% efficacy. These findings mark a crucial step forward in malaria prevention efforts, especially considering the alarming statistics from the World Health Organization, which attributes a majority of the nearly 250 million global malaria cases and over 600,000 malaria deaths in 2022 to the Plasmodium falciparum parasite, with most cases occurring in African children.
The antibody, isolated from a volunteer vaccinated with an experimental malaria vaccine, underwent modifications to prolong its durability in the bloodstream following administration. Previous studies had shown the potential of antibodies against P. falciparum infection, but the new antibody, manufactured at a higher concentration, enabled subcutaneous injection, making it more accessible for mass distribution in resource-limited settings.
The clinical trial, led by NIAID in collaboration with the University of Sciences, Techniques and Technologies of Bamako, Mali, was conducted in two parts, first focusing on safety assessment and then evaluating clinical efficacy in children aged 6 to 10 years. Ongoing efforts include further clinical development targeting high-risk populations such as infants, children with severe anemia, and pregnant women.
As scientists continue to explore the efficacy of the experimental antibody in diverse populations and settings, the prospect of a potent and accessible malaria prevention strategy offers hope in the global fight against this deadly disease.
The study’s publication marks a significant milestone in malaria research and underscores the collaborative efforts driving innovation in global health initiatives.
