Clinical Trial

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

Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2026-01-23; most recent amendment 2026-07-13.
Status change: Not Yet Recruiting → Recruiting 2026-03-02
Trial Details
NCT Number NCT07379580
Lead Sponsor BioNTech SE
Collaborators: Coalition for Epidemic Preparedness Innovations
Conditions Mpox (Monkeypox), Smallpox, Orthopoxvirus Infection
Enrollment 310 participants
Start Date 2026-02-20
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-11