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L9LS monoclonal antibody reduces malaria infection in children in western KenyaA malaria shot for babies shows real protection in Kenya

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Key Takeaway
Consider L9LS for malaria prevention in children, noting 42.7% efficacy and need for higher doses in high-transmission areas.

This Phase 2 randomized controlled trial was conducted in Siaya County, western Kenya, a high perennial malaria transmission setting. The study enrolled infants and children aged 5-59 months (part 2) and 5-10 years (parts 1a/1b), with a total of 420 participants. The intervention was subcutaneous L9LS monoclonal antibody at various doses (5, 10, 20, 30, or 40 mg/kg) in parts 1a/1b, and in part 2, either two doses of L9LS at 10-20 mg/kg at baseline and month 6, or one dose at baseline with placebo at month 6. The comparator was placebo (normal saline). The primary outcomes were efficacy (Plasmodium falciparum infection detected by blood smear over 12 months) and safety (incidence and severity of solicited adverse events within 7 days and serious adverse events throughout follow-up). Over 12 months, 70 of 106 children in the two-dose L9LS group had at least one infection, compared with 91 of 110 in the placebo group, yielding a protective efficacy of 42.7% (95% CI 22.5-57.7; p=0.0003). Results for the one-dose regimen were not reported. Safety was acceptable: grade 3 or worse treatment-related adverse events occurred after four (1%) of 384 L9LS injections and two (1%) of 338 placebo injections, with no serious adverse events related to the trial. All grade 3 or worse events resolved by study end. Key limitations include the single geographic setting and the 12-month follow-up, which does not establish long-term safety. In practice, L9LS was protective against malaria in young children without evident safety concerns over 6-12 months; a higher dose might be needed for high-level efficacy in intense perennial transmission settings.

A malaria shot for babies shows real protection in Kenya

Malaria is one of the biggest threats to young children in Africa. Now, a single injection appears to cut the risk of infection for many months. In a new trial in western Kenya, a long-acting antibody called L9LS reduced malaria cases by 43% in children under five.

That matters because current prevention tools, like bed nets and preventive medicines, don’t work perfectly for every child. Families in high-transmission areas often face repeated infections that can lead to fever, anemia, and hospital stays.

Malaria is caused by a parasite spread by mosquitoes. In parts of western Kenya, transmission happens year-round, not just in a single rainy season. Young children are especially vulnerable because their immune systems are still developing.

The study focused on children aged 5 to 59 months in Siaya County, Kenya, where malaria is common. Researchers tested a monoclonal antibody called L9LS, which is designed to block the parasite before it can cause illness. Unlike daily pills, this shot is meant to last for months.

Old prevention vs. a new approach

For years, families have relied on bed nets, indoor spraying, and preventive medicines given seasonally. These tools help, but gaps remain. Some children miss doses, mosquitoes develop resistance, and bed nets wear out.

But here’s the twist: L9LS is not a vaccine. It’s a ready-made antibody that gives immediate protection. Think of it like a guard posted at the door, stopping the parasite before it gets inside. The goal is a single shot that lasts through the malaria season.

Antibodies are proteins the body makes to fight invaders. L9LS is a lab-made antibody that targets a key part of the malaria parasite. When given by injection, it circulates in the blood and blocks the parasite from infecting liver cells.

A simple analogy: imagine the parasite as a key trying to unlock a door. L9LS fits the lock so the key can’t turn. The antibody stays active for months, offering protection without daily pills.

The study design in plain terms

Researchers in Kenya ran a two-part, double-blind trial. First, they tested safety and different doses in small groups of children aged 5 months to 10 years. Then, in the main efficacy part, they enrolled 324 children aged 5 to 59 months.

Children were randomly assigned to one of three groups: two doses of L9LS (at baseline and at 6 months), one dose at baseline with a placebo at 6 months, or placebo at both times. All children were followed for 12 months with monthly clinic visits and blood tests. The main goal was to see how many children developed malaria during that period.

In the two-dose group, 70 of 106 children (66%) had at least one malaria infection over 12 months. In the placebo group, 91 of 110 children (83%) were infected. That translates to a protective efficacy of 42.7%—meaning the antibody cut the risk of infection by nearly half.

Safety was closely monitored. Across all study parts, only four serious adverse events occurred after L9LS injections and two after placebo, none of which were linked to the antibody. Most side effects were mild and resolved quickly.

But there's a catch. The protection was lower than what was seen in earlier seasonal trials. The authors suggest that higher doses may be needed in areas with year-round transmission.

What experts are saying

The trial was funded by the Gates Foundation and published in The Lancet. The authors conclude that L9LS is safe and shows meaningful protection in young children, but they note that dose optimization may be key for high-transmission settings.

What this means for families

This shot is not yet available for routine use. If you’re a parent or caregiver in a malaria-endemic area, talk to your local health provider about current prevention options, such as bed nets and seasonal preventive medicines. Clinical trials like this one help scientists figure out the best way to protect children in the years ahead.

Limitations to keep in mind

This was a phase 2 trial in one region of Kenya. The sample size was moderate, and the follow-up lasted 12 months. Results in other settings may differ, especially where malaria transmission is seasonal or where different parasite strains circulate.

What happens next

Researchers are now exploring whether a higher dose of L9LS can boost protection in young children. Larger trials in multiple countries will help confirm safety and effectiveness. If results hold up, regulators could consider approval in the coming years, but no timeline is set yet.

Study Details

Study typeRct
Sample sizen = 72
EvidenceLevel 2
Follow-up120.0 mo
PublishedApr 2026
View Original Abstract ↓
BACKGROUND: Malaria remains a major cause of mortality globally, especially among young children in sub-Saharan Africa. The long-acting monoclonal antibody L9LS has shown high efficacy in preventing malaria in children aged 6-10 years exposed to seasonal transmission but remains untested in perennial transmission settings and younger children. We assessed the safety, tolerability, and efficacy of L9LS in infants and children in a high perennial malaria transmission setting. METHODS: This double-blind, two-part, randomised, placebo-controlled, phase 2 trial was done in Siaya county in western Kenya. In parts 1a and 1b, we tested the safety and tolerability of L9LS using an age de-escalation and dose escalation approach and randomly assigned (3:1) cohorts of healthy children (three cohorts aged 5-10 years, three cohorts aged 5-59 months, and two cohorts aged 5-71 months) to L9LS at doses of 5, 10, 20, 30, or 40 mg/kg subcutaneously or to placebo (normal saline). In part 2, healthy children aged 5-59 months were randomly assigned (1:1:1) by use of centralised computer-generated lists to receive two doses of L9LS at 10-20 mg/kg at baseline and month 6, one dose of L9LS at baseline and placebo at month 6, or placebo at both timepoints. Children were followed up for 12 months with monthly clinic visits and blood smear collections. Primary safety outcomes were incidence and severity of local and systemic solicited adverse events within 7 days of dosing and serious adverse events throughout follow-up. The primary efficacy endpoint was Plasmodium falciparum infection detected by blood smear over 12 months. Primary analyses were done in the modified intention-to-treat population, consisting of all randomly assigned participants who received the study intervention. This trial is registered with ClinicalTrials.gov (NCT05400655) and is complete. FINDINGS: In parts 1a and 1b, 96 children were enrolled and randomly assigned between Oct 1, 2022, and Jan 16, 2024; 72 participants were assigned to L9LS and 24 were assigned to placebo. In part 2, 324 children aged 5-59 months were enrolled and randomly assigned between Jan 26 and June 2, 2023; 108 children were assigned to one-dose L9LS, 106 to two-dose L9LS, and 110 to placebo. Across all study parts, grade 3 or worse treatment-related adverse events occurred after four (1%) of 384 L9LS injections and two (1%) of 338 placebo injections; these events all resolved by study end. The proportion of solicited and unsolicited adverse events was similar across all L9LS dose groups. There were no serious adverse events related to the trial. In part 2, 70 (66%) of 106 children in the two-dose L9LS group had at least one P falciparum infection during the 12-month follow-up versus 91 (83%) of 110 children in the placebo group (protective efficacy 42·7%, 95% CI 22·5-57·7; p=0·0003). INTERPRETATION: L9LS was protective against malaria in young children in western Kenya without evident safety concerns over 6-12 months. A higher dose of L9LS might be needed to achieve high-level efficacy against malaria in young children exposed to intense perennial P falciparum transmission. FUNDING: Gates Foundation.
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