A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
Safety, Reactogenicity, and Immunogenicity of an Mpox mRNA Vaccine Candidate, BNT166a, in Healthy Participants Aged 18 Years and Older in African Countries: A Randomized, Double-blind, Placebo-controlled Phase II Trial
BioNTech SE
310 participants
Feb 20, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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).
Exclusion Criteria6
- 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.
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Interventions
Intramuscular injection. Injections should be given in the deltoid muscle, using the same non-dominant arm for all IMP doses.
Intramuscular injection. Injections should be given in the deltoid muscle, using the same non-dominant arm for all IMP doses.
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07379580