One shot, six months of malaria shield? a new trial tests a powerful antibody in children
NCT ID NCT07082205
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This trial tests whether a single dose of an experimental antibody, L9LS, can prevent malaria in children who have just been hospitalized with severe malaria or severe anemia. These children face a high risk of getting sick again for months after leaving the hospital. The study compares the antibody to the current standard of care—three monthly courses of preventive malaria pills. If the antibody works as well or better, it could offer a simpler, longer-lasting way to protect these vulnerable children.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- L9LS, an antimalarial monoclonal antibody given as a single intravenous dose
- What this could lead to
- If successful, a single shot could replace monthly preventive pills, offering months of protection against malaria for children after hospital discharge.
- What could go wrong
- The trial is still in progress, and results may not confirm the antibody's effectiveness or safety in this younger, sicker population compared to standard preventive care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 398 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2025
- Expected to finish
-
Apr 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Up to 9 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Inclusion criteria for enrolment into the pre-study screening period * Aged \<10 years of both sexes * Severe anaemia or severe malaria: Initially hospitalised with haemoglobin \<5.0 g/dl or PCV \<15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital, or severe malaria, defined as a requirement for parenteral artesunate in the opinion of the treating clinician and the presence of microscopy or RDT confirmed Plasmodium infection * Resident in catchment area Eligibility criteria for enrolment * Fulfilled the pre-study screening eligibility criteria * Post-transfusion haemoglobin \>=5.0 g/dl or PCV \>=15% * Clinically stable, able to take oral medication, able to feed (for breastfeeding children) or eat (for older children) and able to sit unaided (for older children who were already able to do so before hospitalisation) * Provision of informed consent by parent or guardian Exclusion criteria for enrolment into the pre-study screening period Exclusion Criteria: Exclusion criteria for enrolment into the pre-study screening period * Recognised specific other causes of severe anaemia (i.e., trauma, haematological malignancy, known bleeding disorders, such as haemophilia) * Sickle cell anaemia/sickle cell disease * Body weight \<5 kg * HIV infection or on daily cotrimoxazole prophylaxis Exclusion criteria for enrolment * Previous enrolment in the present study * Children who are scheduled to receive any of the four doses of the malaria vaccine within 6 months after enrolment. * Received any RTS,S or R21 malaria vaccine primary series or booster dose within the last 14 days inclusive * On or eligible for cotrimoxazole prophylaxis for HIV infection or HIV exposure * Children with sickle cell disease because they are eligible for daily proguanil * Known hypersensitivity to artemether-lumefantrine or dihydroartemisinin-piperaquine * Anticipated to reside for more than 1 month of the 6-month (26 weeks) intervention period outside of the catchment area (e.g. boarding school) * Use or known need at enrolment for concomitant prohibited medication during the first 6 months post-discharge * Ongoing or planned participation in another clinical trial involving ongoing or scheduled treatment with prohibited medicinal products or active follow-up during the first 26 weeks post-discharge * A known need at the time of enrolment for scheduled surgery during the first 6 months post-discharge * Suspected non-compliance with the follow-up schedule and protocol in the opinion of the investigator * Known heart conditions or family history of congenital prolongation of the QTc interval, or taking medicinal products that are known to prolong the QTc interval
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Malaria are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
HomaBay County Teaching and Referral Hospital
Kisumu, Nyanza, 40300, Kenya
-
Siaya County Referral Hospital
Kisumu, Nyanza, 40600, Kenya
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Finger-Prick blood test reveal hidden malaria in the placenta?
- Can a digital assistant and quick tests stop unnecessary antibiotics for kids?
- Can scheduled malaria drugs shield infants from severe illness?
- Can a simple preventive drug cut malaria and anemia in infants?
- Can monthly malaria pills sharpen Children's minds?
- Can simple reminders keep children safe from malaria after hospital?