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

NCT03882528 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-03-30

Study results available
· View outcomes & findings →

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

Conditions

  • Malaria,Falciparum

Interventions

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).

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • James E Moon, MD · Walter Reed Army Institute of Research (WRAIR)

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-04
Primary Completion
2019-04-25
Completion
2019-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03882528 on ClinicalTrials.gov