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Last Updated: 04/05/2024

Safety, tolerability, immunogenicity, and efficacy of RNA-based malaria vaccine in healthy malaria naïve adults

Objectives

The aim of this study is to evaluate the safety, tolerability, immunogenicity, and efficacy of an investigational RNA-based vaccine (BNT165e) for the prevention of P. falciparum malaria in healthy malaria-naive adults.

Principal Institution

BioNTech, Germany

Rationale and Abstract

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.

Study Design

Study type: Interventional
Enrollment: 126 participants
Primary purpose: Prevention
Allocation:Randomized
Interventional Model: Sequential assignment
Masking : Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
NCT number: NCT06069544
Phase: Phase I/II

External reference

Clinical trial registration

Thematic Categories

Vaccines (Immune Correlates)

Date

Nov 2023 — Dec 2025

Project Site

United States

Safety, tolerability, immunogenicity, and efficacy of RNA-based malaria vaccine in healthy malaria naïve adults

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