Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The objective of our study is to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive DNA vaccine in healthy volunteers.

Detailed Description
-----------------
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 single arm, open-labeled and a total of 20 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.

Official Title
-----------------
A Phase 1/2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Subjects

Conditions
-----------------
SARS-CoV-2

Intervention / Treatment
-----------------
* Drug: GX-19N
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to comply with all study procedures and voluntarily signs informed consent form Healthy adult male or female aged 19-55 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 who have or with a history of disease corresponding to other hepatobiliary, kidneys, nervous systems (middle or peripheral), respiratory machines (e.g. asthma, pneumonia, etc., endocrine systems (uncontrolled diabetes, hyperlipidemia, etc.) and cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension), blood tumors, urinary machines, mental, musculoskeletal systems, immune system (rheumatoid arthritis, systemic arthritis, mumps, immunodeficiency disease) 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
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
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 1 year post vaccination | 
| GMFR of Antigen-specific Binding Antibody Titers | Geometric mean fold rise (GMFR) of antigen-specific binding antibody after vaccination | Through 1 year post vaccination | 
| Percentage of Subjects Who Seroconverted After Vaccination | Seroconversion defines when FRNT50 is detected more than four times from the baseline after vaccination | Through 1 year post vaccination | 
| GMT and GMFR of Neutralizing Antibody Level | Geometric mean titer (GMT) and Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination | Through 1 year post vaccination | 
| GMFR of Neutralizing Antibody Level | Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination | Through 1 year post vaccination | 
| GMSN and GMFR of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay | Geometric mean spot numbers (GMSN) and Geometric mean fold rise (GMFR) of SFU after vaccination | Through 1 year post vaccination |