At a glance
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An Exploratory Phase I, Randomized, Observer-blind, Placebo-controlled Dose Escalation Trial Evaluating the Safety, Tolerability and Immunogenicity of an Investigational RNA-based Vaccine for Active Immunization Against Malaria
In Brief
A Phase 1 clinical trial evaluating BNT165b1 and Placebo for Malaria. Completed, enrolled 60 participants across 5 sites.
Detailed Summary
This first-in-human clinical trial, was a dose escalation multi-center trial designed 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). BNT165b1 was evaluated at three dose levels (DLs) to select a safe and tolerable dose in a 3-dose schedule.
Study Details
Timeline
Interventions
RNA vaccine for active immunization against malaria administered as intramuscular injection.
Placebo matched to RNA vaccine administered as intramuscular injection.