A Clinical Study Investigating the Safety and Immune Responses After Immunization with Investigational Monkeypox Vaccines

Trial status:Recruitment Complete
Study Identifier:
BNT166-01
ClinicalTrials.gov Identifier:
NCT05988203
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
Recruitment Complete

Trial details

Medical Condition
  • Mpox
    • Study Drug
  • Biological: BNT166a
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 65 Years
    Estimated Trial Date
    Sep 2023 - Sep 2025

    Protocol summary

    This is a dose-escalation, Phase I/II trial evaluating the safety, tolerability, reactogenicity and immunogenicity of the investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against monkeypox (mpox). This trial will start with the two substudies, i.e., substudy A (SSA) and substudy B (SSB). This trial will be initiated with the dose-escalation SSA. In substudy A and substudy B, dosing will start with an initial sentinel group, followed by the expansion cohort. Further substudies are planned to begin soon. This study was initially planned to investigate two vaccine candidates (the quadrivalent BNT166a and the trivalent BNT166c). The sponsor decided to not activate the groups with BNT166c.

    Trial locations

    Location
    Status
    Location
    California Research Foundation
    San Diego, California, United States, 92123
    Status
    Location
    Alliance for Multispecialty Research, LLC
    Kansas City, Missouri, United States, 64114
    Status
    Location
    Alliance for Multispecialty Research, LLC
    Knoxville, Tennessee, United States, 37909
    Status
    Location
    University of Washington Virology Research Clinic
    Seattle, Washington, United States, 98104
    Status
    Location
    Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
    Cambridge, United Kingdom, CB2 0QQ
    Status
    Location
    Royal Surrey County Hospital Foundation Trust, NIHR Royal Surrey Clinical Research Facility
    Guildford, United Kingdom, GU2 7XP
    Status