NCT03882528

Evaluate the Infectivity Equivalence of Current and New Lots of Plasmodium Falciparum Strain NF54

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a single center, open label CHMI study. CHMI will consist of exposure to Plasmodium falciparum sporozoites through the bites of infected mosquitoes. After the challenge, subjects will be evaluated daily for the development of malaria infection using a blood smear. Unless previously diagnosed and fully treated, subjects will be required to stay in a hotel for a maximum of 12 nights starting on or around the evening of Day 7 post challenge. All subjects diagnosed with malaria infection based on smears will be prescribed a standard malaria treatment regimen to begin on the day that parasitemia is detected. Subjects who do not become parasitemic (via smear) by Day 19 will be empirically treated for malaria. After the hotel phase, all challenged subjects will have a final scheduled follow-up visit on Day 28 (±7 days).

Conditions

• Malaria,Falciparum

Interventions

Type	Name	Description
BIOLOGICAL	Plasmodium falciparum malaria parasite	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).

Timeline

• Start date: 2019-03-04
• Primary completion: 2019-04-25
• Completion: 2019-05-16
• First posted: 2019-03-20
• Last updated: 2021-03-30
• Results posted: 2021-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study