Safety and Immunogenicity of EXG-5003
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04863131 |
Recruitment Status :
Completed
First Posted : April 28, 2021
Last Update Posted : January 26, 2023
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Sponsor:
Fujita Health University
Collaborator:
Elixirgen Therapeutics, Inc.
Information provided by (Responsible Party):
Yohei Doi, Fujita Health University
Tracking Information | |||||
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First Submitted Date ICMJE | April 15, 2021 | ||||
First Posted Date ICMJE | April 28, 2021 | ||||
Last Update Posted Date | January 26, 2023 | ||||
Actual Study Start Date ICMJE | April 28, 2021 | ||||
Actual Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of Participants Reporting Local and Systemic Adverse Events [ Time Frame: Day 1 up to Day 365 post dose ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Immunogenicity of EXG-5003 | ||||
Official Title ICMJE | Safety and Immunogenicity of Intradermal SARS-CoV-2 Vaccine EXG-5003 in Healthy Adults | ||||
Brief Summary | This is a First in Human, randomized, placebo-controlled Phase I/II trial to evaluate the safety and immunogenicity of the intradermal COVID-19 vaccine, EXG-5003 in healthy adults. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | COVID-19 | ||||
Intervention ICMJE |
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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 | Completed | ||||
Actual Enrollment ICMJE |
40 | ||||
Original Estimated Enrollment ICMJE |
60 | ||||
Actual Study Completion Date ICMJE | January 24, 2023 | ||||
Actual Primary Completion Date | December 31, 2022 (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 | 20 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Japan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04863131 | ||||
Other Study ID Numbers ICMJE | EXG-5003-J01 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Yohei Doi, Fujita Health University | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Fujita Health University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Elixirgen Therapeutics, Inc. | ||||
Investigators ICMJE |
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PRS Account | Fujita Health University | ||||
Verification Date | January 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |