This first-in-human Phase 1 clinical trial is a dose escalation multi-center trial designed to assess the safety, tolerability, and immunogenicity of the vaccine component, BNT165b1, an ribonucleic acid (RNA)-lipid nanoparticle (LNP) encoding for part of the Plasmodium falciparum circumsporozoite protein (PfCSP).

BNT165b1 will be evaluated at three dose levels (DLs) to select a safe and tolerable dose in a 3-dose schedule. The trial will enroll 60 participants using a staggered dose escalation.