Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT04336410 |
Recruitment Status :
Completed
First Posted : April 7, 2020
Last Update Posted : April 15, 2022
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Sponsor:
Inovio Pharmaceuticals
Collaborator:
Coalition for Epidemic Preparedness Innovations
Information provided by (Responsible Party):
Inovio Pharmaceuticals
Tracking Information | |||||||||||||
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First Submitted Date ICMJE | April 3, 2020 | ||||||||||||
First Posted Date ICMJE | April 7, 2020 | ||||||||||||
Last Update Posted Date | April 15, 2022 | ||||||||||||
Actual Study Start Date ICMJE | April 3, 2020 | ||||||||||||
Actual Primary Completion Date | February 10, 2022 (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 | Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers | ||||||||||||
Official Title ICMJE | Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers | ||||||||||||
Brief Summary | This is an open-label trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device in healthy adult volunteers. | ||||||||||||
Detailed Description | Not Provided | ||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Coronavirus Infection | ||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* 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 |
120 | ||||||||||||
Original Estimated Enrollment ICMJE |
40 | ||||||||||||
Actual Study Completion Date ICMJE | February 10, 2022 | ||||||||||||
Actual Primary Completion Date | February 10, 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 | 18 Years and older (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT04336410 | ||||||||||||
Other Study ID Numbers ICMJE | COVID19-001 | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Inovio Pharmaceuticals | ||||||||||||
Original Responsible Party | Same as current | ||||||||||||
Current Study Sponsor ICMJE | Inovio Pharmaceuticals | ||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||
Collaborators ICMJE | Coalition for Epidemic Preparedness Innovations | ||||||||||||
Investigators ICMJE |
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PRS Account | Inovio Pharmaceuticals | ||||||||||||
Verification Date | April 2022 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |