Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the study is to demonstrate safety and immunogenicity of COVID-19 preventive DNA vaccine in elderly individuals.
This clinical study is a phase 1 clinical trial to investigate the safety and immunogenicity of COVID-19 preventive vaccine by intramuscularly administration in the elderly.
This study is designed as single arm, open-labeled and a total of 30 subjects will be enrolled.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GX-19N | Experimental | Dose A of GX-19N will be intramuscularly administered via Electroporator(EP) on day 1 and day 29. (Optional administration on day 57) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GX-19N | Drug | DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Solicited Adverse Event(AE)s | 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 Event(SAE)s | percentage of subjects with SAEs | Through 1 year post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| GMT of Antigen-specific Binding Antibody Titers | Geometric mean titer (GMT) of antigen-specific binding antibody after vaccination | Through 12 weeks after vaccination |
| GMFR of Antigen-specific Binding Antibody Titers |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Antigen-specific IFN-gamma Cellular Immune Response by Immunophenotyping assay | Antigen-specific IFN-γ T cell immune response assessed by immunophenotyping assay after vaccination | Through 12 weeks after vaccination |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jun Yong Choi, MD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance hospital | Seoul | 03722 | South Korea | |||
| Gangnam Severance hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000720499 | GX-19N vaccine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Geometric mean fold rise (GMFR) of antigen-specific binding antibody after vaccination
| Through 12 weeks after vaccination |
| Percentage of Subjects Who Seroconverted After Vaccination | Seroconversion defines as 4-fold increase in antibody titer after vaccination | Through 12 weeks after vaccination |
| GMT of Neutralizing Antibody Level | Geometric mean titer (GMT) of neutralizing antibody after vaccination | Through 12 weeks after vaccination |
| GMFR of Neutralizing Antibody Level | Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination | Through 12 weeks after vaccination |
| GMSN of Spot Forming Unit (SFU) detected by interferon(IFN)-gamma ELISPOT assay | Geometric mean spot numbers (GMSN) of SFU after vaccination | Through 12 weeks after vaccination |
| GMFR of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay | Geometric mean fold rise (GMFR) of SFU after vaccination | Through 12 weeks after vaccination |
| Seoul |
| 06273 |
| South Korea |