COVID-19
Conditions
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.
Interventions
BIOLOGICALEXG-5003
COVID-19 self-replicating mRNA vaccine
BIOLOGICALPlacebo
placebo solution
Sponsors
Elixirgen Therapeutics, Inc.
Fujita Health University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Reporting Local and Systemic Adverse Events | Day 1 up to Day 365 post dose |
Secondary
| Measure | Time frame |
|---|---|
| Flowcytometry assay to enumerate the frequency of T cells expressing CD3, CD4, CD8, CD62L, CD45RA, IFN-γ, IL-4, CD107, TNF, IL-2, IL-6, CD154 (CD40L), Perforin, and Granzyme B. | Day15, Day29, Day43, Day57, Day92, Day183, Day365 |
| Assessment of T cells by Intracellular cytokine staining assays | Day15, Day29, Day57, |
| Genometric Mean Titer (GMT) of serum anti-RBD IgG | Day15, Day29, Day43, Day57, Day92, Day183, Day365 |
| GMT of neutralizing antibody | Day15, Day29, Day43, Day57, Day92, Day183, Day365 |
Countries
Japan
Outcome results
None listed