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

NCT07379580 · readout ≤ 315 d

Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With Coalition for Epidemic Preparedness Innovations.

Phase

Phase 2

Status

Recruiting

Study type

Interventional

Design

Randomized · Quadruple · Prevention

Enrollment

310estimated

Sites

Countries

Democratic Republic of the Congo, South Africa

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2026-02-20

actual

When the study began enrolling

Primary completion

Jun 2027

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Jun 2027

estimated

The whole study's end, after follow-up

First posted

2026-01-30

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-11

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Mpox (Monkeypox)
Smallpox
Orthopoxvirus Infection

Interventions

Biological: BNT166a
Other: Placebo

Primary outcomes

what the primary-completion date above is the date OF

Number (and percentage) of participants with at least one solicited local reaction (pain, erythema/redness, induration/swelling)

measured For up to 7 days following each dose

Number (and percentage) of participants with at least one solicited systemic reaction (fever, headache, fatigue/tiredness, muscle pain/myalgia, joint pain/arthralgia, chills, diarrhea, vomiting)

measured For up to 7 days following each dose

Number (and percentage) of participants with at least one use of antipyretics/analgesics

measured For up to 7 days following each dose

Number (and percentage) of participants with at least one unsolicited adverse event (AE) (post-Dose 1)

measured From Dose 1 to 28 days post-Dose 1

Number (and percentage) of participants with at least one unsolicited AE (post-Dose 2)

measured From Dose 2 to 28 days post-Dose 2

Number (and percentage) of participants with at least one serious adverse event

measured From Dose 1 until the end of study, i.e., up to ~14 months

Number (and percentage) of participants with at least one AE of special interest

measured From Dose 1 until the end of study, i.e., up to ~14 months

Number (and percentage) of participants with at least one medically attended AE

measured From Dose 1 until the end of study, i.e., up to ~14 months

Number (and percentage) of participants with at least one AE leading to a participant's withdrawal from the study

measured From Dose 1 until the end of study, i.e., up to ~14 months

Permalink · BNTX's whole pipeline · Catalyst calendar · Every registered study · What changed