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PfSPZ Vaccine Trial in Malian Children

NCT04940130 ↗

Phase 2 Completed 290 enrolled Sanaria Inc. Malaria Research and Training Center, Bamako, Mali · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collabUniversity of the Sciences, Techniques and Technologies of Bamako · collab
RandomizedParallel-groupQuadruple-blindPrevention

Summary

In this randomized, double-blind, placebo-controlled trial, 268 healthy Malian children aged 6-10 years, residing in Bancoumana and surrounding villages, will be administered three doses of 9.0x10\^5 Pf sporozoites (PfSPZ) of PfSPZ Vaccine (or placebo) at 1, 8, and 29-days using direct venous inoculation (DVI). The study is composed of a single cohort with two arms (categorized by placebo control/experimental groups) designed to assess the safety, immunogenicity and protective efficacy of PfSPZ Vaccine. All subjects will receive artemether-lumefantrine (AL) approximately 1- 2 weeks before the first dose of PfSPZ Vaccine or normal saline for clearance of Pf parasitemia. Vaccinated participants and non-immunized controls will be followed for safety and monitored for development of parasitemia through the natural malaria transmission season to estimate vaccine efficacy (VE).

Timeline

Start
2022-04-01
Primary completion
2022-12-10
Completion
2022-12-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Sanaria® PfSPZ Vaccine Vaccine 900000 unknown Intravenous

Indications

Plasmodium falciparum malaria