The New England Journal of MedicineSubcutaneous Administration of a Monoclonal Antibody to Prevent Malaria

Enhanced Protection for Children Against Malaria Through Subcutaneous Monoclonal Antibody Administration

A recent phase 2 trial in Mali has demonstrated that the subcutaneous administration of the monoclonal antibody L9LS effectively prevents Plasmodium falciparum infection and clinical malaria in children. This study extends previous findings from adult trials, offering new insights into pediatric malaria prevention strategies over a 6-month period in a region endemic with the disease.

Study Design:

• Population: 225 children aged 6 to 10 years in Mali, a region where P. falciparum is endemic.
• Methodology: A randomized, placebo-controlled trial examining the efficacy and safety of two dosage levels of L9LS (150 mg and 300 mg) administered subcutaneously.
• Duration: Assessment conducted over a 6-month malaria season, with bi-weekly blood smears to detect infection.

Key Findings:

• Safety: No safety concerns were reported in either the adult preliminary trial or the children’s trial.
• Infection Rates: P. falciparum infection occurred in 48% of the 150-mg group, 40% of the 300-mg group, and 81% in the placebo group.
• Efficacy: The 150-mg dose showed 66% efficacy, and the 300-mg dose showed 70% efficacy in preventing infection. Efficacy against clinical malaria was 67% with the 150-mg dose and 77% with the 300-mg dose.
• Statistical Significance: Both dosages significantly prevented P. falciparum infection and clinical malaria compared to placebo (P<0.001 for all).

HCN Medical Memo
This study reinforces the potential of monoclonal antibodies as a preventive strategy against malaria in pediatric populations in endemic regions. It highlights the need for further research into dose optimization and long-term effects to enhance global malaria prevention efforts.

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