Malaria Clinical Trial
Official title:
Controlled Human Malarial Infection by Intravenous Injection of Plasmodium Falciparum Sporozoites in Non-Immune Adults
The study is designed to establish the best dose to safely infect healthy individuals with Plasmodium falciparum sporozoites (PfSPZ) via intravenous (IV) injection.
TÜCHMI-001 is a single center, open label, randomized and controlled human pilot study to
optimize controlled human malaria infection(CHMI) administered by PfSPZ Challenge.
Volunteers will be inoculated with PfSPZ Challenge. Controls will receive the PfSPZ
Challenge by ID administration. The remaining volunteers will receive the PfSPZ Challenge by
IV administration. All volunteers recruited will be healthy adults aged between 18 and 45
years. Safety and infectivity data will be collected for each of the regimens and
dose-levels.
Volunteers and clinical investigators will not be blinded to group allocation, however
laboratory investigators processing blood films and samples for PCR analysis will be blinded
to group allocation.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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