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One shot, six months of malaria shield? a new trial tests a powerful antibody in children

NCT ID NCT07082205

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.