NCT05581641

Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The trial had enrolled participants into three cohorts by dose level who were randomized 4:1 to BNT165b1: placebo. The trial used a staggered dose escalation schema with sentinel participants for Dose 1 in all cohorts.

Conditions

• Malaria

Interventions

Type	Name	Description
BIOLOGICAL	BNT165b1	RNA vaccine for active immunization against malaria administered as intramuscular injection.
OTHER	Placebo	Placebo matched to RNA vaccine administered as intramuscular injection.

Timeline

• Start date: 2022-12-15
• Primary completion: 2024-02-23
• Completion: 2024-09-06
• First posted: 2022-10-14
• Last updated: 2025-09-03
• Results posted: 2025-09-03

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study