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| Name | Class |
|---|---|
| Elixirgen Therapeutics, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXG-5003 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXG-5003 | Biological | COVID-19 self-replicating mRNA vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Local and Systemic Adverse Events | Day 1 up to Day 365 post dose |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yohei Doi, MD | Fujita Health University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujita Health University Hospital | Toyoake | Aichi-ken | Japan |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Placebo |
| Biological |
placebo solution |
|
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |