A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination with an Investigational RNA-based Vaccine Against Malaria
Trial status:Recruiting
Study Identifier:
BNT165-02
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Recruiting
Trial details
Medical Condition
Study Drug
Phase
Phase 1
Sex
Female & Male
Age
18 - 55 Years
Estimated Trial Date
Nov 2023 - Sep 2025
Protocol 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.
Trial locations
Location
Status
Location
AMR Tempe
Tempe, Arizona, United States, 85281
Status
Recruiting
Location
University of Maryland, Center for Vaccine Development
Baltimore, Maryland, United States, 21201
Status
Recruiting
Location
AMR Las Vegas
Las Vegas, Nevada, United States, 89119
Status
Recruiting
Location
AMR Knoxville
Knoxville, Tennessee, United States, 37909
Status
Recruiting
Location
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
Status
Recruiting