COVID-19 Clinical Trial
Official title:
Safety and Immunogenicity of Intradermal SARS-CoV-2 Vaccine EXG-5003 in Healthy Adults
Verified date | January 2023 |
Source | Fujita Health University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Japan | Fujita Health University Hospital | Toyoake | Aichi |
Lead Sponsor | Collaborator |
---|---|
Fujita Health University | Elixirgen Therapeutics, Inc. |
Japan,
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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