A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA‑based Mpox Vaccine Candidate in Africa

Trial status:Will Be Recruiting
Trial ID:
BNT166-02
NCT ID:
NCT07379580
EudraCT ID:
N/A
EU Trial (CTIS) Number:
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
Collaborator:
Coalition for Epidemic Preparedness Innovations
Will Be Recruiting

Trial Details

This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, reactogenicity, and immunogenicity after one and two doses of BNT166a or placebo in healthy participants.

Medical Condition
  • Unmapped
    • Study Drug
  • BNT166a
    • Phase
    Phase 2
    Type
    Interventional
    Estimated Enrolment
    310
    Estimated Trial Date
    Feb 2026 - Jun 2027

    Trial Participant Requirements

    Age
    18 - 64 Years
    Sex
    Female & Male
    Healthy Volunteers
    Yes
    Inclusion and Exclusion Criteria
    Inclusion criteria

      Key Inclusion Criteria (applicable to all participants unless otherwise specified):

    • Are male or female individuals ≥18 years of age at the time of giving informed consent:
      • Cohort 1: ≥18 to ≤45 years of age
      • Cohort 2: ≥18 to ≤64 years of age
    • Cohort 1: Participants must be Orthopoxvirus-naïve (have no history of smallpox or mpox vaccination or mpox infection).
    • Cohort 2: Participants must be Orthopoxvirus-experienced (have evidence of mpox or smallpox vaccination or mpox infection at least 2 years prior to consent).

      • Key Exclusion Criteria (applicable to all participants unless otherwise specified):

    • Have had recent exposure to mpox (defined as close contact with a probable or confirmed case of mpox within the past 28 days, or have evidence of mpox infection or mpox vaccination within 2 years prior to consent).
    • Have a contraindication, warning and/or precaution to vaccination with a messenger ribonucleic acid (mRNA) Coronavirus disease 2019 (COVID-19) vaccine as specified in the Summary of Product Characteristics for BNT162b2 (COMIRNATY United States Prescribing Information/European Union Summary of Product Characteristics) and BNT166 Investigator Brochure.
    • Have a history of allergies, hypersensitivities, or intolerance to the study treatments including any excipients thereof.
    • Have a current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmias.
    • Have any known bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
    • Have a body mass index ≤18.5 kg/m\^2 or ≥35 kg/m\^2.

      • NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

    Trial Locations

    Location
    Status
    Location
    University of Kinshasa UNIKIN
    Kinshasa, Unmapped, 01306
    Status
    Location
    Institute National de Recherche Biomedicale
    Kinshasa, Unmapped, 5345
    Status
    Location
    TASK Applied Science
    Cape Town, South Africa, 7405
    Status
    Location
    TREAD Research Pty Ltd
    Cape Town, South Africa, 7530
    Status
    Location
    Desmond Tutu Health Foundation Masiphumelele Clinic
    Cape Town, South Africa, 7975
    Status
    Location
    Perinatal HIV Research Unit
    Johannesburg, South Africa, 1864
    Status