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ACTIVE NOT RECRUITING
NCT06069544
PHASE1/PHASE2

A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria

Sponsor: BioNTech SE

View on ClinicalTrials.gov

Summary

This is a randomized, dose-escalation Phase I/IIa trial to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P. falciparum malaria in healthy malaria-naive adults. The multi-antigen malaria vaccine (designated BNT165e) is a combination of three distinct RNAs, BNT165c and BNT165d (composed of BNT165d1 and BNT165d2), encoding P. falciparum antigens encapsulated in lipid nanoparticles. The BNT165c RNA encodes the full Plasmodium falciparum circumsporozoite protein. The BNT165d1 and BNT165d2 RNAs both encode conserved, immunogenic segments of liver stage-expressed proteins.

Official title: A Randomized, Dose-escalation Phase I/IIa Trial With Controlled Human Malaria Infection to Evaluate Safety, Tolerability, Immunogenicity and Efficacy of an Investigational RNA-based Vaccine for Prevention of P. Falciparum Malaria in Healthy Malaria naïve Adults

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

163

Start Date

2023-11-13

Completion Date

2026-03

Last Updated

2025-06-06

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

BNT165e

Multi-antigen RNA-based vaccine for active immunization against malaria administered as intramuscular injection

OTHER

Placebo

Isotonic NaCl solution (0.9%)

Locations (5)

AMR Tempe

Tempe, Arizona, United States

University of Maryland, Center for Vaccine Development

Baltimore, Maryland, United States

AMR Las Vegas

Las Vegas, Nevada, United States

AMR Knoxville

Knoxville, Tennessee, United States

Clinical Trials of Texas

San Antonio, Texas, United States