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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04863131
Other study ID # EXG-5003-J01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date April 28, 2021
Est. completion date January 24, 2023

Study information

Verified date January 2023
Source Fujita Health University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 24, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 55 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
EXG-5003
COVID-19 self-replicating mRNA vaccine
Placebo
placebo solution

Locations

Country Name City State
Japan Fujita Health University Hospital Toyoake Aichi

Sponsors (2)

Lead Sponsor Collaborator
Fujita Health University Elixirgen Therapeutics, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Reporting Local and Systemic Adverse Events Day 1 up to Day 365 post dose
Secondary Flowcytometry assay to enumerate the frequency of T cells expressing CD3, CD4, CD8, CD62L, CD45RA, IFN-?, IL-4, CD107, TNF, IL-2, IL-6, CD154 (CD40L), Perforin, and Granzyme B. Day15, Day29, Day43, Day57, Day92, Day183, Day365
Secondary Assessment of T cells by Intracellular cytokine staining assays Day15, Day29, Day57,
Secondary Genometric Mean Titer (GMT) of serum anti-RBD IgG Day15, Day29, Day43, Day57, Day92, Day183, Day365
Secondary GMT of neutralizing antibody Day15, Day29, Day43, Day57, Day92, Day183, Day365
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