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

NCT07379580 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2026-03-04

No results posted yet for this study

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.

Conditions

  • Mpox (Monkeypox)
  • Smallpox
  • Orthopoxvirus Infection

Interventions

BIOLOGICAL

BNT166a

Intramuscular injection. Injections should be given in the deltoid muscle, using the same non-dominant arm for all IMP doses.

OTHER

Placebo

Intramuscular injection. Injections should be given in the deltoid muscle, using the same non-dominant arm for all IMP doses.

Sponsors & Collaborators

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • BioNTech SE

    lead INDUSTRY

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-20
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Democratic Republic of the Congo
  • South Africa

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07379580 on ClinicalTrials.gov