A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines
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ClinicalTrials.gov Identifier: NCT05988203 |
Recruitment Status :
Recruiting
First Posted : August 14, 2023
Last Update Posted : March 13, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | August 4, 2023 | ||||
First Posted Date ICMJE | August 14, 2023 | ||||
Last Update Posted Date | March 13, 2024 | ||||
Actual Study Start Date ICMJE | September 21, 2023 | ||||
Estimated Primary Completion Date | October 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines | ||||
Official Title ICMJE | A Randomized, Partially Observer-blind, Dose-escalation, Phase I/II Trial Evaluating the Safety and Immunogenicity of Investigational RNA-based Mpox Vaccine Candidates | ||||
Brief Summary | This is a dose-escalation, Phase I/II trial evaluating the safety, tolerability, reactogenicity and immunogenicity of the investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against monkeypox (mpox). This trial will start with the two substudies, i.e., substudy A (SSA) and substudy B (SSB). This trial will be initiated with the dose-escalation SSA. In substudy A and substudy B, dosing will start 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. |
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Detailed Description | Substudy A is a dose-escalation, Phase I substudy to assess the reactogenicity, safety and immunogenicity of up to three dose levels of the multivalent vaccine candidate BNT166a in ~48 healthy participants with no prior history of known or suspected smallpox vaccination (vaccinia-naïve participants). Two doses will be given ~31 days apart. Substudy B is a Phase I substudy to assess the reactogenicity, safety and immunogenicity of the multivalent vaccine candidate BNT166a in ~16 healthy participants with prior history of smallpox vaccination (vaccinia-experienced). Two doses will be given ~31 days apart. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Monkeypox | ||||
Intervention ICMJE | Biological: BNT166a
Multivalent ribonucleic acid (RNA)-based vaccine for active immunization against monkeypox administered as intramuscular injection.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
64 | ||||
Original Estimated Enrollment ICMJE |
96 | ||||
Estimated Study Completion Date ICMJE | May 2025 | ||||
Estimated Primary Completion Date | October 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05988203 | ||||
Other Study ID Numbers ICMJE | BNT166-01 1006947 ( Other Identifier: Integrated Research Application System (IRAS) ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | BioNTech SE | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | BioNTech SE | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | BioNTech SE | ||||
Verification Date | March 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |