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

NCT ID: NCT04445389

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-17
• Study Completion Date: 2020-12-17

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 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.

Conditions

SARS-CoV-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

GX-19: Dose A

Dose A of GX-19 will be intramusculary administered via EP on day 1 and day 29.

Group Type: EXPERIMENTAL

GX-19

Intervention Type: DRUG

DNA vaccine expressing SARS-CoV-2 S-protein antigen

GX-19: Dose B

Dose B of GX-19 will be intramusculary administered via EP on day 1 and day 29.

Group Type: EXPERIMENTAL

GX-19

Intervention Type: DRUG

DNA vaccine expressing SARS-CoV-2 S-protein antigen

GX-19: Dose C

Dose C of GX-19 will be intramusculary administered via PharmaJet® Needle Free Delivery on day 1 and day 29.

Group Type: PLACEBO_COMPARATOR

GX-19

Intervention Type: DRUG

DNA vaccine expressing SARS-CoV-2 S-protein antigen

Placebo: Dose A, B, or C

Placebo will be intramusculary administered on day 1 and day 29 via EP or PharmaJet® Needle Free Delivery

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Saline

Interventions

GX-19

DNA vaccine expressing SARS-CoV-2 S-protein antigen

Intervention Type: DRUG

Saline

Saline

Intervention Type: DRUG

Other Intervention Names

DNA vaccine expressing SARS-CoV-2 S-protein antigen

Eligibility Criteria

Inclusion Criteria

Each participant must meet all of the following criteria during the screening period:

1. Able and willing to comply with all study procedures and voluntarily signs informed consent form

2. Healthy adult male or female aged 19-50 years

3. 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.

4. 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:

1. Immunosuppresion including immunodeficiency disease or family history

2. Any history of malignant disease within the past 5 years

3. Scheduled to undergo any surgery or dental treatment during the study

4. Having received immunoglobulin or blood-derived drugs or being expected to be administered within 3 months prior to administration.

5. Having relied on antipsychotic drugs and narcotic analgesics within 6 months before administration

6. Positive of serum test at screening

7. Suspected of drug abuse or a history within 12 months prior to administration

8. Active alcohol use or history of alcohol abuse

9. 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

10. History of hypersensitivity to vaccination such as Guillain-Barre syndrome

11. 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)

12. Having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants

13. 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

14. Acute fever, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration

15. Other vaccination history within 28 days prior to the administration or being scheduled to be inoculated during the study

16. History of having taken immunosuppressant or Immune modifying drug within 3 months prior to administration

17. Having participated and had clinical trial drug administration in another clinical trial or biological equivalence study within 6 months prior to the administration

18. 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

19. Fertile female who do not agree to use effective contraception methods (condoms, contraceptive diaphragm, intrauterine contraceptive devices) during the study

20. Any other clinically significant medical or psychiatric finding which is considered inappropriate by investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genexine, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JungWon Woo, Ph.D.

Role: STUDY_DIRECTOR

Genexine, Inc.

Locations

Severance hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

GX-19-HV-001

Identifier Type: -

Identifier Source: org_study_id