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Last Updated: 04/05/2024
Safety, tolerability and immunogenicity of RNA-based malaria vaccine
Objectives
This study aims to assess the safety, tolerability, and immunogenicity of the vaccine component, BNT165b1, a ribonucleic acid (RNA)-lipid nanoparticle (LNP) encoding for part of the Plasmodium falciparum circumsporozoite protein (PfCSP).
Rationale and Abstract
The trial will enroll participants into three cohorts by dose level who will be randomized 4:1 to BNT165b1:placebo. The trial will use a staggered dose escalation schema with sentinel participants for Dose 1 in all cohorts.
Study Design
Study type: Interventional
Enrollment:602 participants
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Sequential assignment
Masking : Triple (Participant, Care Provider, Investigator)
NCT number: NCT05581641
Phase: Phase I
External reference
Thematic Categories
Date
Dec 2022 — Feb 2024
Project Site
Related Resources
