Plasmodium Falciparum Clinical Trial
Official title:
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
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.
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