NCT07322068

Perennial Malaria Chemoprevention in the Malaria Vaccine Era

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,290 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 1 Day – 10 Weeks
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Malaria, Falciparum

Interventions

Type	Name	Description
DRUG	Sulfadoxine pyrimethamine + Amodiaquine	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.
DRUG	Dihydroartemisinin Piperaquine	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.
DRUG	Dihydroartemisinin Piperaquine Placebo	Participants receive oral placebos with an identical appearance to DP active drug.
DRUG	Sulfadoxine pyrimethamine + Amodiaquine placebo	Participants receive oral placebos with an identical appearance to SPAQ active drug.

Timeline

• Start date: 2026-09-01
• Primary completion: 2033-06-01
• Completion: 2033-06-01
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: Uganda