mRNA vaccine (BNT166a) for mpox and smallpox prevention in adults in Africa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2 trial gives participants two doses of the mRNA vaccine BNT166a or placebo at least 28 days apart and follows them for about 14 months. Participants are grouped into two cohorts: orthopoxvirus-naïve adults aged 18–45 and orthopoxvirus-experienced adults aged 18–64. The study measures safety, local and systemic reactogenicity, and immune responses after one and two doses. Data will compare vaccine versus placebo within each cohort to characterize tolerability and antibody responses.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Kinshasa UNIKIN
  Kinshasa, Democratic Republic of the Congo Recruiting
• Institute National de Recherche Biomedicale
  Kinshasa, Democratic Republic of the Congo Recruiting
• TASK Applied Science
  Cape Town, South Africa Recruiting
• TREAD Research Pty Ltd
  Cape Town, South Africa Recruiting
• Desmond Tutu Health Foundation Masiphumelele Clinic
  Cape Town, South Africa Recruiting
• Perinatal HIV Research Unit
  Johannesburg, South Africa Recruiting

Study contacts

• Study coordinator: BioNTech clinical trials patient information
• Email: patients@biontech.de
• Phone: +49 6131 9084

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.