Actively Recruiting
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
Led by BioNTech SE · Updated on 2026-03-04
310
Participants Needed
6
Research Sites
66 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
C
Coalition for Epidemic Preparedness Innovations
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female individuals aged 18 years or older at the time of consent
- Cohort 1: Age 18 to 45 years and Orthopoxvirus-naïve (no history of smallpox or mpox vaccination or infection)
- Cohort 2: Age 18 to 64 years and Orthopoxvirus-experienced (evidence of mpox or smallpox vaccination or infection at least 2 years prior)
You will not qualify if you...
- Recent exposure to mpox within 28 days or mpox vaccination/infection within 2 years prior to consent
- Contraindications or warnings for mRNA COVID-19 vaccines as specified in product information
- History of allergies or intolerance to study treatments or their ingredients
- Current or past cardiovascular diseases such as myocarditis, pericarditis, myocardial infarction, heart failure, cardiomyopathy, or significant arrhythmias
- Known bleeding disorders or conditions that contraindicate intramuscular injection
- Body mass index less than 18.5 or greater than 35 kg/m²
- Other protocol-defined criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University of Kinshasa UNIKIN
Kinshasa, Democratic Republic of the Congo, 01306
Not Yet Recruiting
2
Institute National de Recherche Biomedicale
Kinshasa, Democratic Republic of the Congo, 5345
Not Yet Recruiting
3
TASK Applied Science
Cape Town, South Africa, 7405
Not Yet Recruiting
4
TREAD Research Pty Ltd
Cape Town, South Africa, 7530
Actively Recruiting
5
Desmond Tutu Health Foundation Masiphumelele Clinic
Cape Town, South Africa, 7975
Not Yet Recruiting
6
Perinatal HIV Research Unit
Johannesburg, South Africa, 1864
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
6
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