NCT04203186

A Clinical Trial to Evaluate Plasmodium Falciparum 7G8 and NF54 Challenge Strains (PfSPZ) in a Head-to-head Comparative Study - (ECG-CHMI)

A Phase 1 Clinical Trial To Evaluate The Safety and Infectivity Of Direct Venus Inoculation of Aseptic, Purified, Cryopreserved Plasmodium Falciparum 7G8 And NF54 Challenge Strains (PfSPZ) in a Head-To-Head Comparative Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A comparison of Malaria events (symptoms and signs of malaria) experienced by subjects infected with PfSPZ Challenge (NF54) vs. PfSPZ Challenge (7G8).

Detailed description

The single center study is designed as a double-blind, randomized, placebo-controlled CHMI trial with 2 parallel test groups to directly compare clinical and laboratory characteristics of the NF54 and 7G8 strains of PfSPZ Challenge. This study will also evaluate signatures of and time to parasitemia by multiple methods and evaluate physiologic status data collected by non-invasive wearable monitors before and during Plasmodium falciparum infection to characterize and trend physiologic changes appearing prior to the onset of parasitemia. PfSPZ Challenge (aseptic, purified, cryopreserved, infectious Plasmodium falciparum sporozoites) or normal saline will be administered by direct venous inoculation (DVI) by 25-gauge needle and syringe to healthy malaria naïve adults. Data generated from samples collected for biomarker assay analysis will be useful for developing predictive models to evaluate the efficacy of malaria vaccine candidates.

Conditions

• Plasmodium Falciparum

Interventions

Type	Name	Description
DRUG	atovaquone-proguanil	Malaria standard treatment regimen

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-06-01
• Completion: 2021-09-01
• First posted: 2019-12-18
• Last updated: 2020-05-08