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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT07379580•BioNTech SE

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.

Detailed Description

This study will include the following cohorts: * Cohort 1: healthy adults aged 18 to 45 years inclusive who are Orthopoxvirus-naïve. * Cohort 2: healthy adults aged 18 to 64 years inclusive who are Orthopoxvirus-experienced. All participants will receive two doses of BNT166a or placebo at least 28 days apart. The planned study duration per participant is \~14 months.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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 Criteria

•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.

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

Key Dates

Start Date

February 20, 2026

Primary Completion Date

June 1, 2027

Completion Date

June 1, 2027

Last Updated

March 4, 2026

Enrollment

310

ESTIMATED participants

Conditions

Mpox (Monkeypox)SmallpoxOrthopoxvirus Infection

Interventions

BNT166a

BIOLOGICAL

Placebo

OTHER

Contacts

BioNTech clinical trials patient information

CONTACT

+49 6131 9084 patients@biontech.de

Epidemiological and Clinical Characteristics of Human Mpox Outbreak in Equateur Province in the Democratic Republic of Congo (Part3)

NCT06984705

Mpox (Monkeypox)

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ACTIVE_NOT_RECRUITINGPHASE2

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Smallpox

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COMPLETEDPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Epidemiological and Clinical Characteristics of Human Mpox Outbreak in Equateur Province in the Democratic Republic of Congo (Part3)

Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS

A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of Age to <50 Years of Age

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A Phase 4, Observational Field Study to Evaluate TPOXX in Patients With Smallpox