Status:
COMPLETED
Safety and Immunogenicity of EXG-5003
Lead Sponsor:
Fujita Health University
Collaborating Sponsors:
Elixirgen Therapeutics, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
20-55 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- Has provided written consent for participation
- Age between 20 and 55
- Has a negative nucleic acid-based test result for SARS-CoV-2
- Has a negative antibody test result for SARS-CoV-2
Exclusion
- Signs and symptoms consistent with COVID-19 upon screening
- History of COVID-19
- Presence of uncontrolled cardiovascular, hematologic, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disease
- Presence of diabetes mellitus
- Presence of active autoimmune disease
- Positive for HBc, HCV or HIV antibody
- History of anaphylactic shock
- History of epilepsy
- Presence of active malignancy
- Presence of lung disease (e.g., COPD, asthma)
- Positive urine pregnancy test within 24 hours
- Pregnant, lactating, planned pregnancy of self (if female) or partner (if male) within 90 days after administration of the trial drug
- If female and premenopausal, not agreeable to contraception for 90 days after second administration of the trial drug
- If male, not agreeable to contraception for 90 days after second administration of the trial drug
- Presence of clinically relevant electrocardiogram or vital sign abnormality at screening
- Participated in a clinical trial of a drug or a medical device within 30 days or a biologic within 90 days
- Received any SARS-CoV-2 vaccine
- Received within 90 days, or is planning to receive during the study period, an immunoglobulin or blood product
- Received within 180 days, or is planning to receive during the study period, a biologic product with immunosuppressive properties
- Received for 14 days or more within 180 days, or is planning to receive during the study period, a corticosteroid
- Deemed ineligible for the study as determined by the principal investigator or a co-investigator
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04863131
Start Date
April 28 2021
End Date
January 24 2023
Last Update
January 26 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan