Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers

Trial status:Recruitment Complete
Trial ID:
BNT164-01
NCT ID:
NCT05537038
EudraCT ID:
2022-000911-29
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
Recruitment Complete

Trial Details

This randomized, placebo-controlled, double-blind, safety and dose-finding Phase Ia trial will evaluate four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a three-dose schedule.

Medical Condition
  • Tuberculosis
    • Trial Drug
  • BNT164a1
    • See more
  • BNT164b1
    • Phase
    Phase 1
    Type
    Interventional
    Estimated Enrolment
    120
    Estimated Trial Date
    Apr 2023 - Jun 2025

    Trial Participant Requirements

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

    Trial Locations

    Location
    Status
    Location
    emovis GmbH
    Berlin, Germany, 10629
    Status
    Location
    CRS Clinical Research Services Berlin GmbH
    Berlin, Germany, 13627
    Status
    Location
    CRS Clinical Research Services Mannheim GmbH
    Mannheim, Germany, 68167
    Status