Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals

Study Overview
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Brief Summary
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The objective of our study is to demonstrate safety and immunogenicity of COVID-19 preventive DNA vaccine in elderly individuals.

Detailed Description
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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.

Official Title
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A Phase 1, Multicenter, Open-Label, Single Arm Study to Investigate the Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals

Conditions
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SARS-CoV-2

Intervention / Treatment
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* Drug: GX-19N


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to comply with all study procedures and voluntarily signs informed consent form Male or female aged 55-85 years Willing to provide specimens such as blood and urine during the study, including end of study visit. Exclusion Criteria: Immunosuppresion including immunodeficiency disease or family history Any history of malignant disease within the past 5 years Scheduled to undergo any surgery or dental treatment during the study Having received immunoglobulin or blood-derived drugs or being expected to be administered within 3 months prior to administration. Having relied on antipsychotic drugs and narcotic analgesics within 6 months before administration Positive of serology test at screening Suspected of drug abuse or a history within 12 months prior to administration Active alcohol use or history of alcohol abuse Serious adverse reaction to a drug containing GX-19N or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history History of hypersensitivity to vaccination such as Guillain-Barre syndrome Those with significant chronic underlying diseases that may increase the risk of COVID-19 or interfere with the evaluation of clinical trial purposes according to the investigator's discretion Having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants Subjects who have been contact with COVID-19 infections in the past prior to administration, have been classified as COVID-19 confirmed patients, medical patients or patients with symptoms or have been identified with SARS and MERS infection history in the past Acute fever, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration Other vaccination history within 28 days prior to the administration or being scheduled to be inoculated during the study History of having taken immunosuppressant or Immune modifying drug within 3 months prior to administration Having participated and had clinical trial drug administration in another clinical trial or biological equivalence study within 6 months prior to the administration Pregnant or breastfeeding female, however, those are allowed to participate in the study only if they stop breastfeeding before participation (fertile female† must be negative in serum pregnancy test at screening Fertile female who do not agree to use effective contraception methods (condoms, contraceptive diaphragm, intrauterine contraceptive devices) during the study Any other clinically significant medical or psychiatric finding which is considered inappropriate by investigator

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GX-19N<br>Dose A of GX-19N will be intramusculary administered via EP on day 1 and day 29. (Optional administration on day 57) | Drug: GX-19N<br>* DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen<br>* Other names: Dose A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 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 |