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

Trial status:Recruiting
Trial ID:
BNT163-01
NCT ID:
NCT05432583
EudraCT ID:
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

This exploratory trial will have three parts. Part A is a dose escalation part, Part B is an expanded safety and dose evaluation part, and Part C is a safety and immunogenicity evaluation part in individuals with recurrent HSV-2 genital herpes.

Part A will focus on the safety evaluations, and in addition, 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 will also enable a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on the safety and immune responses to BNT163.

Part C will evaluate safety and immunogenicity of BNT163 compared to a placebo in a three-dose regimen in subjects with a history of HSV-2 recurrent genital herpes.

Medical Condition
  • HSV
    • Trial Drug
  • BNT163
    • Phase
    Phase 1
    Type
    Interventional
    Estimated Enrolment
    308
    Estimated Trial Date
    Dec 2022 - Oct 2026

    Trial Participant Requirements

    Age
    18 - 55 Years
    Sex
    Female & Male
    Healthy Volunteers
    Yes

    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
    Active, not recruiting
    Location
    Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania, United States, 19104
    Status
    Recruiting