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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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SARS-CoV-2

Intervention / Treatment
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* Drug: GX-19
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Each participant must meet all of the following criteria during the screening period: Able and willing to comply with all study procedures and voluntarily signs informed consent form Healthy adult male or female aged 19-50 years Those who weigh 50 kg to 90kg and have a body mass index (BMI) of 18.0 kg/m2 to 28.0 kg/m2 at screening visit. Willing to provide specimens such as blood and urine during the study, including end of study visit. Exclusion Criteria: Participants meeting any of the following criteria at the Screening Visit: 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 serum 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-19 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
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Minimum Age: 18 Years
Maximum Age: 50 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
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Phase 1: Open-label, Dose escalation (3-arms) Phase 2a: Randomized, Double-blinded, Placebo-controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GX-19: Dose A<br>Dose A of GX-19 will be intramusculary administered via EP on day 1 and day 29. | Drug: GX-19<br>* DNA vaccine expressing SARS-CoV-2 S-protein antigen<br>* Other names: DNA vaccine expressing SARS-CoV-2 S-protein antigen;|
| Experimental: GX-19: Dose B<br>Dose B of GX-19 will be intramusculary administered via EP on day 1 and day 29. | Drug: GX-19<br>* DNA vaccine expressing SARS-CoV-2 S-protein antigen<br>* Other names: DNA vaccine expressing SARS-CoV-2 S-protein antigen;|
| Placebo Comparator: GX-19: Dose C<br>Dose C of GX-19 will be intramusculary administered via PharmaJet® Needle Free Delivery on day 1 and day 29. | Drug: GX-19<br>* DNA vaccine expressing SARS-CoV-2 S-protein antigen<br>* Other names: DNA vaccine expressing SARS-CoV-2 S-protein antigen;|
| Placebo Comparator: Placebo: Dose A, B, or C<br>Placebo will be intramusculary administered on day 1 and day 29 via EP or PharmaJet® Needle Free Delivery | Drug: Saline<br>* Saline<br>|

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 |
| --- | --- | --- |
| 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 | 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 |