A Study to Evaluate the Safety and Immunogenicity of COVID-19 (AdimrSC-2f) Vaccine
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ClinicalTrials.gov Identifier: NCT04522089 |
Recruitment Status :
Recruiting
First Posted : August 21, 2020
Last Update Posted : January 13, 2021
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Sponsor:
Adimmune Corporation
Information provided by (Responsible Party):
Adimmune Corporation
Tracking Information | |||||
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First Submitted Date ICMJE | August 12, 2020 | ||||
First Posted Date ICMJE | August 21, 2020 | ||||
Last Update Posted Date | January 13, 2021 | ||||
Actual Study Start Date ICMJE | August 24, 2020 | ||||
Actual Primary Completion Date | November 20, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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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 | A Study to Evaluate the Safety and Immunogenicity of COVID-19 (AdimrSC-2f) Vaccine | ||||
Official Title ICMJE | A Randomized, Single Center, Open-label, Dose-finding, Phase I Study to Evaluate the Safety and Immunogenicity of Pandemic Virus Vaccine, AdimrSC-2f (SARS-CoV-2), in Healthy Volunteers | ||||
Brief Summary | This study aims to evaluate the safety and immunogenicity of the preventative vaccine, AdimrSC-2f, in healthy volunteers aged from 20 to 60 years old. | ||||
Detailed Description | The objectives of this phase I study are:
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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 | COVID-19 | ||||
Intervention ICMJE | Biological: AdimrSC-2f
AdimrSC-2f is a candidate vaccine against COVID-19 developed by Adimmune Corporation (Adimmune). Using the baculovirus-insect cells expression system, the recombinant receptor binding domain (RBD) of SARS-CoV-2 spike (S) protein is amplified and purified. AdimrSC-2f is formulated in the different dosages of Spike (S) protein without/with aluminum content as adjuvant.
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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 |
70 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 20, 2021 | ||||
Actual Primary Completion Date | November 20, 2020 (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 60 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Taiwan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04522089 | ||||
Other Study ID Numbers ICMJE | ADPCT20011X | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Adimmune Corporation | ||||
Study Sponsor ICMJE | Adimmune Corporation | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Adimmune Corporation | ||||
Verification Date | August 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |