RecruitingPhase 2NCT07379580

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

Sponsor

BioNTech SE

Enrollment

310 participants

Start Date

Feb 20, 2026

Study Type

INTERVENTIONAL

Conditions

Mpox (Monkeypox)Orthopoxvirus Infection smallpox

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

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called BNT166a and Placebo for people with mpox (monkeypox), orthopoxvirus infection, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years to 64 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBNT166a

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

OTHERPlacebo

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

Locations(6)

University of Kinshasa UNIKIN

Kinshasa, Democratic Republic of the Congo

Institute National de Recherche Biomedicale

Kinshasa, Democratic Republic of the Congo

TASK Applied Science

Cape Town, South Africa

TREAD Research Pty Ltd

Cape Town, South Africa

Desmond Tutu Health Foundation Masiphumelele Clinic

Cape Town, South Africa

Perinatal HIV Research Unit

Johannesburg, South Africa

View Full Details on ClinicalTrials.gov

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NCT07379580

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