Malaria, Falciparum
Conditions
Brief 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.
Interventions
DRUGSulfadoxine 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.
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.
DRUGDihydroartemisinin Piperaquine Placebo
Participants receive oral placebos with an identical appearance to DP active drug.
DRUGSulfadoxine pyrimethamine + Amodiaquine placebo
Participants receive oral placebos with an identical appearance to SPAQ active drug.
Sponsors
University of California, San Francisco
Infectious Diseases Research Collaboration, Uganda
National Institute of Allergy and Infectious Diseases (NIAID)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 10 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of symptomatic malaria | 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. |
Countries
Uganda
Outcome results
None listed