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Perennial Malaria Chemoprevention in the Malaria Vaccine Era

ConditionMalaria, Falciparum
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-10
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • Dihydroartemisinin Piperaquine Placebo

    Drug

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

  • Sulfadoxine pyrimethamine + Amodiaquine placebo

    Drug

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

Treatment groups

1,290 Participants
are divided into 3 treatment groups
Group A: PMC-PlaceboPlacebo comparator 2 interventions
Group B: PMC-SPAQExperimental treatment 2 interventions
Group C: PMC-DPExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of symptomatic malaria

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.

Time frame
2.5 months to 60 months of age

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Masafu General Hospital Status unavailable Busia DistrictUgandaUganda

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

University of California, San Francisco

Collaborator

Infectious Diseases Research Collaboration, Uganda

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: