Health Trials

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

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

Treatments tested in this trial

  • Sulfadoxine pyrimethamine + Amodiaquine
  • Dihydroartemisinin Piperaquine
  • Dihydroartemisinin Piperaquine Placebo
  • Sulfadoxine pyrimethamine + Amodiaquine placebo

Treatment groups

1,290 Participants
are divided into 3 treatment groups

Locations

1

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

Masafu General Hospital Status unavailable Busia DistrictUgandaUganda

Sponsors and collaborators

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