A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines
Completed · Phase 1/Phase 2
Conditions studied: Monkeypox
In brief
This is a dose-escalation, Phase I/II study evaluating the safety, tolerability, reactogenicity and immunogenicity of the investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against monkeypox (mpox). This study started with substudy A (SSA) and substudy B (SSB) for which recruitment has been completed. A Substudy C (SSC) was planned, but the sponsor decided not to conduct it. This study will therefore continue with substudy D (SSD). In SSA and SSB, dosing started with an initial sentinel group, followed by the expansion cohort. This study was initially planned to investigate two vaccine candidates (the quadrivalent BNT166a and the trivalent BNT166c). The sponsor decided to not activate the groups with BNT166c.
Key facts
- Study ID
- NCT05988203
- Run by
- BioNTech SE
- People needed
- 96
- Starts
- 2023-09-21
- Expected to finish
- 2026-03-04
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
Where it is running
- California Research Foundation — San Diego, California, United States
- Alliance for Multispecialty Research, LLC — Kansas City, Missouri, United States
- Alliance for Multispecialty Research, LLC — Knoxville, Tennessee, United States
- University of Washington Virology Research Clinic — Seattle, Washington, United States
- Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom
- Royal Surrey County Hospital Foundation Trust, NIHR Royal Surrey Clinical Research Facility — Guildford, United Kingdom
- Guy's and St Thomas' NHS Foundation Trust of St Thomas' Hospital — London, United Kingdom
- Medicine Evaluation Unit Ltd, The Langley Building, Wythenshawe Hospital — Manchester, United Kingdom
- University Hospital Southampton — Southampton, United Kingdom
Full record on ClinicalTrials.gov
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