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The sponsor decided to change the investigational product for a strategic reason.
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The objective of our study is to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive DNA vaccine in healthy volunteers.
This clinical study is phase 1/2a clinical trial to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive vaccine by intramuscularly administration in healthy volunteers.
Phase 1 of this study is designed as dose escaltion, single arm, open-labeled and a total of 60 subjects will be enrolled. Phase 2a of study is designed as randomized, double-blind, placebo controlled and a total of 150 subjects are planned to be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GX-19: Dose A | Experimental | Dose A of GX-19 will be intramusculary administered via EP on day 1 and day 29. |
|
| GX-19: Dose B | Experimental | Dose B of GX-19 will be intramusculary administered via EP on day 1 and day 29. |
|
| GX-19: Dose C | Placebo Comparator | Dose C of GX-19 will be intramusculary administered via PharmaJet® Needle Free Delivery on day 1 and day 29. |
|
| Placebo: Dose A, B, or C | Placebo Comparator | Placebo will be intramusculary administered on day 1 and day 29 via EP or PharmaJet® Needle Free Delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GX-19 | Drug | DNA vaccine expressing SARS-CoV-2 S-protein antigen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of solicited adverse events | solicited local and systemic AEs after vaccination | Through 1 year post vaccination |
| Incidence of unsolicited adverse events | unsolicited AEs after vaccination | Through 1 year post vaccination |
| Incidence of serious adverse events | percentage of subjects with SAEs | Through 1 year post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer (GMT) of antigen-specific binding antibody titers | Change from baseline in antigen-specific binding antibody titers | Through 1 year post vaccination |
| Percentage of subjects who seroconverted after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in antigen-specific IFN-g cellular immune response | Antigen-specific IFN-γ T cell immune response assessed before/after vaccination | Through 1 year post vaccination |
Inclusion Criteria:
Each participant must meet all of the following criteria during the screening period:
Exclusion Criteria:
Participants meeting any of the following criteria at the Screening Visit:
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| Name | Affiliation | Role |
|---|---|---|
| JungWon Woo, Ph.D. | Genexine, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance hospital | Seoul | 03722 | South Korea |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Phase 1: Open-label, Dose escalation (3-arms) Phase 2a: Randomized, Double-blinded, Placebo-controlled
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| Saline | Drug | Saline |
|
Seroconversion rate can be calculated based on test results reaching the quantifiable antibody level after vaccination
| Through 1 year post vaccination |
| Geometric mean titer (GMT) of neutralizing antibody level | NAb is regarded as produced when FRNT50 is detected more than four times the baseline after vaccination | Through 1 year post vaccination |
| Geometric mean fold rise (GMFR) of antigen-specific binding antibody titers | Change from baseline in antigen-specific binding antibody titers | Through 1 year post vaccination |
| D017670 |
| Sodium Compounds |