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Malaria prevention in infants may strengthen immunity for years

NCT ID NCT04978272

Prevention Sponsor: Grant Dorsey, M.D, Ph.D. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial in Uganda tests whether giving young children monthly malaria prevention medicine (dihydroartemisinin-piperaquine) from 8 weeks to 1 or 2 years of age helps them develop stronger immunity against malaria later. 924 children are enrolled and followed until age 4. The goal is to see if early prevention reduces malaria cases after treatment stops, compared to no prevention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dihydroartemisinin-piperaquine (DP)
What this could lead to
If successful, this could show that preventing malaria early in life helps children build stronger immunity, reducing infections later.
What could go wrong
This is a large trial but still early-stage for this specific approach. Results may not apply to other regions, and DP may cause side effects like nausea or heart rhythm changes.

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

924 people

The number who actually took part.

Started

Feb 2022

Expected to finish

May 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 2 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Born to HIV-uninfected mother enrolled in parent clinical trial of intermittent preventative treatment of malaria in pregnancy (IPTp-SP vs. IPTp-DP vs. IPTp-SP+DP, NCT 04336189) 2. Resident of Busia District 3. Provision of informed consent by parent/guardian 4. Agreement to present for any illness and avoid, where possible, medications outside the study protocol. Exclusion Criteria: 1. Intention of moving outside Busia district during the study period 2. Active medical problem requiring in-patient evaluation or chronic medical condition requiring frequent medical attention

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Conditions

The condition(s) this trial relates to.

malaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malaria

Contacts and locations

Locations

  • IDRC - Tororo Research Clinic

    Tororo, Uganda

More trials for these conditions

Other studies related to the condition(s) this trial covers.