A comparison of Malaria events (symptoms and signs of malaria) experienced by subjects infected with PfSPZ Challenge (NF54) vs. PfSPZ Challenge (7G8).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Malaria standard treatment regimen
Difference in the pre-patent period
The difference in the time of first malaria event (symptom or sign of malaria),in subjects infected with PfSPZ Challenge (NF54) vs. PfSPZ Challenge (7G8)
Time frame: 29 days
Difference in the total number of malaria events
The difference in the total number of Grade 2 or greater malaria events (symptoms and signs of malaria) experienced by subjects infected with PfSPZ Challenge (NF54) vs PfSPZ Challenge (7G8)
Time frame: 29 days
Determine differences in pre-patent periods
Determine differences in prepatent periods in subjects infected with PfSPZ Challenge (NF54) vs PfSPZ Challenge (7G8) as detected by TBS, RDT, hsRDT and by PCR
Time frame: 29 days
Determine differences in the growth rate of parasites
Determine differences in the growth rate of parasites in the blood of subjects infected by PfSPZ Challenge (NF54) vs PfSPZ Challenge (7G8) as detected by PCR
Time frame: 29 days
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