A Clinical Trial in Healthy Volunteers to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions

Trial status:Recruiting
Study Identifier:
BNT163-01
ClinicalTrials.gov Identifier:
NCT05432583
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
  • HSV
    • Study Drug
  • Biological: BNT163
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 55 Years
    Estimated Trial Date
    Dec 2022 - Dec 2025

    Protocol summary

    This exploratory trial will have two parts. Part A is a dose escalation part and Part B is an expanded safety and dose evaluation part. Part A will focus on the safety evaluations, but vaccine-induced immune responses (specifically neutralizing antibodies) will also be analyzed to assess if there is a dose-response. Part B of the trial will expand the safety characterization for two dose levels of BNT163 selected based on Part A data and also enable a more comprehensive assessment of the impact of pre-existing immunity to Herpes Simplex Virus (HSV)-1 and -2 on the safety and BNT163-induced immune responses than could be assessed in Part A.

    Trial locations

    Location
    Status
    Location
    Alliance for Multispecialty Research, LLC
    Tempe, Arizona, United States, 85281
    Status
    Recruiting
    Location
    Great Lakes Clinical Trials - Flourish Research
    Chicago, Illinois, United States, 60640
    Status
    Recruiting
    Location
    Accellacare Raleigh Medical Group
    Raleigh, North Carolina, United States, 27609
    Status
    Recruiting
    Location
    Accellacare PMG Research Wilmington LLC
    Wilmington, North Carolina, United States, 28401
    Status
    Recruiting
    Location
    CTI Clinical Research Center
    Cincinnati, Ohio, United States, 45212
    Status
    Recruiting
    Location
    Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania, United States, 19104
    Status
    Recruiting