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

Trial status:Study Complete
Study Identifier:
BNT165-01
ClinicalTrials.gov Identifier:
NCT05581641
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
Study Complete

Trial details

Medical Condition
  • Malaria
    • Study Drug
  • Biological: BNT165b1
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 55 Years
    Estimated Trial Date
    Dec 2022 - Feb 2024

    Protocol summary

    This first-in-human clinical trial, is a dose escalation multi-center trial designed to assess the safety, tolerability, and immunogenicity of the vaccine component, BNT165b1, an ribonucleic acid (RNA)-lipid nanoparticle (LNP) encoding for part of the Plasmodium falciparum circumsporozoite protein (PfCSP). BNT165b1 will be evaluated at three dose levels (DLs) to select a safe and tolerable dose in a 3-dose schedule.

    Trial locations

    Location
    Status
    Location
    Alliance for Multispecialty Research, LLC
    Tempe, Arizona, United States, 85281
    Status
    Location
    University of Maryland, Center for Vaccine Development
    Baltimore, Maryland, United States, 21201
    Status
    Location
    Alliance for Multispecialty Research, LLC
    Las Vegas, Nevada, United States, 89119
    Status
    Location
    Alliance for Multispecialty Research, LLC
    Knoxville, Tennessee, United States, 37909
    Status
    Location
    Clinical Trials of Texas, Inc.
    San Antonio, Texas, United States, 78229
    Status