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NCT05988203 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines
A Phase 1 study of Monkeypox, sponsored by BioNTech SE.
- Active
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 8
- Study locations
NCT05988203: Active Phase 1 study of Monkeypox, sponsored by BioNTech SE.
NCT05988203 is a Phase 1 study of Monkeypox that is active but no longer recruiting, run by BioNTech SE. The registered enrollment target is 96 participants, below the 260-participant average among 3 other Monkeypox trials with a reported enrollment target (63% lower). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05988203, a Phase 1 study of Monkeypox, is active but no longer recruiting, sponsored by BioNTech SE.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
- 8
- Study locations
Study Summary
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.
Primary Outcome
For each group
Conditions Studied
Interventions
- BIOLOGICAL BNT166a
Study Locations (8)
Other
- Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust - Cambridge
- Royal Surrey County Hospital Foundation Trust, NIHR Royal Surrey Clinical Research Facility - Guildford
- Guy's and St Thomas' NHS Foundation Trust of St Thomas' Hospital - London
- University Hospital Southampton - Southampton
California
- California Research Foundation - San Diego
Missouri
- Alliance for Multispecialty Research, LLC - Kansas City
Tennessee
- Alliance for Multispecialty Research, LLC - Knoxville
Washington
- University of Washington Virology Research Clinic - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2023-09-21 |
| Est. Completion | 2026-03 |
| Phase | Phase 1 |
What the registry record for NCT05988203 still lists
NCT05988203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 260-participant average among 3 other Monkeypox trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Monkeypox appearing as the primary indexed condition, and to 1 intervention - of which BNT166a is the first listed.
NCT05988203 lists 8 locations in 5 states (Other, California, Missouri).
Frequently Asked Questions
What is clinical trial NCT05988203 about?
NCT05988203 is a clinical study titled "A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines". 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) f...
What is the current status of trial NCT05988203?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2023-09-21. Estimated completion is 2026-03.
What conditions does trial NCT05988203 study?
This clinical trial studies the following conditions: Monkeypox.
What interventions are being tested in trial NCT05988203?
The interventions under investigation include: BNT166a (BIOLOGICAL).
Who is sponsoring clinical trial NCT05988203?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05988203 being conducted?
This trial has 8 study locations across California, Missouri, Tennessee, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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