At a glance
ClinicalIndex Comparison Record- ✓Age 18–50 years
- ✓Good general health with normal EKG and screening labs
- ✓Able to understand study requirements and pass comprehension assessment (≥80%)
- ✓Willing to remain in designated hotel for post-CHMI follow-up (~7 days until antimalarial treatment completed)
- ✕Any prior malaria infection or malaria vaccination
- ✕Travel to falciparum-endemic country in past 6 months or planned during study
- ✕More than 5 years residence in falciparum-endemic area
- ✕Any serious organ disease (heart, liver, lungs, kidneys)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Bridging Trial to Evaluate the Infectivity Equivalence of Current and New Lots of Plasmodium Falciparum Strain NF54 (Clone 3D7) Within the WRAIR Controlled Human Malaria Infection (CHMI) Model
In Brief
A Phase 1 clinical trial evaluating Plasmodium falciparum malaria parasite for Malaria,Falciparum. Completed, enrolled 12 participants across 1 site.
Detailed Summary
Objectives: Primary: • To characterize the infectivity of the new lot of Plasmodium falciparum strain 3D7 within the standard WRAIR CHMI model as compared to the current lot (historical data) Secondary: * To assess safety of the new lot of P falciparum parasites * To assess the kinetics of detecting parasitemia and parasite clearance by quantitative polymerase chain reaction (qPCR) as compared to blood smear * To obtain plasma samples to restore the testing control pool for malaria serology testing and for future malaria research
Study Details
Timeline
Interventions
Laboratory cultured Plasmodium falciparum strain 3D7 delivered via the bite of 5 infected mosquitoes with salivary gland scores of at least 2+ (11-100 sporozoites observed).