Last Updated: 30/04/2024
Phase 2 of PfSPZ Vaccine in children in Mali
Objectives
The objective of this study is to measure the number of participants with possibly, probably, or definitely related serious adverse events (SAEs).
Malaria Research and Training Center (MRTC), University of Sciences, Techniques and Technologies of Bamako (USTTB), Mali
University of Sciences Techniques and Technologies of Bamako (USTTB), Mali
National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), United States
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 9.0×10^5 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).
Study type: Interventional
Enrollment: 290 participants
Primary purpose: Prevention
Allocation:Randomized
Interventional Model: Randomized, placebo controlled, with concurrent arms
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinded
NCT number: NCT04940130
Phase: Phase II
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