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NCT Number: NCT07322068

Perennial Malaria Chemoprevention in the Malaria Vaccine Era

Malaria remains a major cause of pediatric deaths and morbidity in Africa. An affordable malaria vaccine, R21, is being deployed in Uganda and other African countries with high malaria transmission, but efficacy is incomplete and wanes rapidly, and R21 does not provide protection until infants complete the primary vaccination series, or ~9 months of age. The goal of this study is to see whether combining R21 vaccination with two novel perennial malaria chemoprevention regimens can enhance protection against malaria compared with R21 alone. This study will take place at Masafu General Hospital (MGH) in Busia District, a rural area in Southeastern Uganda bordering Lake Victoria.

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Key information

Conditions

Malaria, Falciparum Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

1 day–10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Masafu General Hospital

Busia District, Uganda

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Residency in Busia District, Uganda
Provision of informed consent by the parent/guardian for her child
Agreement to come to the study clinic for any febrile episode or other illness and avoid, where possible, medications given outside the study protocol

Exclusion criteria

Intention of permanently moving outside Busia district during the study period
Active medical problem requiring inpatient evaluation or chronic medical condition requiring frequent medical attention at the time of screening
Evidence of sickle cell disease (Hemoglobin SS genotype)
Biological mother known to be HIV positive

Treatment and study plan

Sulfadoxine pyrimethamine + Amodiaquine

Drug

Each round of study drugs will consist of once daily oral dosing x 3 days. The first daily dose will be directly observed in the study clinic, and day 2 and day 3 doses will be provided for administration at home. Daily dosing of SPAQ will be based on manufacturer's recommendations: infants <12 months of age will receive one dose of 12.5/250 mg SP and 3 daily doses of 76.5 mg AQ, children >=12 months of age will receive one does of 25/5000 mg SP and 3 daily doses of 153 mg AQ.

Other names: SPAQ

Dihydroartemisinin piperaquine

Drug

Each round of study drugs will consist of once daily oral dosing x 3 days. The first daily dose will be directly observed in the study clinic, and day 2 and day 3 doses will be provided for administration at home. Daily dosing of DP will consist of half-strength tablets given once a day for 3 consecutive days and will depend on bodyweight, targeting 4 mg/kg of dihydroartemisinin and 24 mg/kg of piperaquine phosphate.

Other names: DP

Dihydroartemisinin Piperaquine Placebo

Drug

Participants receive oral placebos with an identical appearance to DP active drug.

Other names: DP Placebo

Sulfadoxine pyrimethamine + Amodiaquine placebo

Drug

Participants receive oral placebos with an identical appearance to SPAQ active drug.

Other names: SPAQ Placebo

Primary outcomes

Incidence of symptomatic malaria

Time frame: 2.5 months to 60 months of age

The incidence of symptomatic malaria is defined as the number of incident episodes of malaria requiring treatment per time at risk. Treatments within 14 days of a prior episode are not considered incident events.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

Infectious Diseases Research Collaboration, Uganda
National Institute of Allergy and Infectious Diseases (NIAID)
University of California, San Francisco

Registry information

Acronym: PMC-VAC

Important dates

Study start: 2026
Primary completion: 2033
Study completion: 2033
First posted: Jan 7, 2026
Registry last updated: Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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