A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines
← catalyst calendarSponsored by BioNTech SE (industry) · BNTX — their whole pipeline →.
Phase
Phase 1/2
Status
Completed
Study type
Interventional
Design
Non randomized · None · Prevention
Enrollment
96actual
Sites
9
Countries
United Kingdom, United States
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 | 2023-09-21 | actual | When the study began enrolling |
| Primary completion | 2025-08-25 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-03-04 | actual | The whole study's end, after follow-up |
| First posted | 2023-08-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Monkeypox
Intervention
- Biological: BNT166a
Primary outcomes
what the primary-completion date above is the date OFSSA, SSB, and SSD - Proportion (%) of participants reporting solicited local reactions at the injection site (pain, erythema/redness, induration/swelling)
measured From Dose 1 through Day 7 post-Dose1 inclusive; and from Dose 2 through Day 7 post-Dose 2 inclusive
SSA, SSB, and SSD - Proportion (%) of participants reporting solicited systemic events (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever)
measured From Dose 1 through Day 7 post-Dose1 inclusive; and from Dose 2 through Day 7 post-Dose 2 inclusive
SSA, SSB, and SSD - Proportion (%) of participants with at least one unsolicited adverse event (AE) occurring from Dose 1 through Day 28 post-Dose 1 inclusive
measured From Dose 1 through Day 28 post-Dose 1 inclusive
SSA, SSB, and SSD - Proportion (%) of participants with at least one unsolicited AE occurring from Dose 2 through Day 28 post-Dose 2 inclusive
measured from Dose 2 through Day 28 post-Dose 2 inclusive
SSA, SSB, and SSD - Proportion (%) of participants with at least one serious adverse event (SAE) occurring from Dose 1 through Day 201 post-Dose 1 inclusive
measured From Dose 1 through Day 201 post-Dose 1 inclusive
SSA, SSB, and SSD - Proportion (%) of participants with at least one adverse event of special interest (AESI) occurring from Dose 1 through Day 201 post-Dose 1 inclusive
measured From Dose 1 through Day 201 post-Dose 1 inclusive
Publications
- PMID 42235570 — linked by the registry
- PMID 38366591 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · BNTX's whole pipeline · Catalyst calendar · Every registered study · What changed