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

NCT ID: NCT04715997

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-30
• Study Completion Date: 2022-04-19

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.

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-19N will be intramusculary administered via EP on day 1 and day 29.

Group Type: EXPERIMENTAL

GX-19N

Intervention Type: DRUG

DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen

Placebo: Normal saline

Placebo will be intramusculary administered via EP on day 1 and day 29.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal saline

Interventions

GX-19N

DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen

Intervention Type: DRUG

Placebo

Normal saline

Intervention Type: DRUG

Other Intervention Names

Dose A; Normal saline

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 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.

Jun Yong Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

KyungHee University Medical Center

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Hanyang University Hospital

Seoul, , South Korea

Gangnam Severance Hospital

Seoul, , South Korea

Ajou University Hospital

Suwon, , South Korea

Countries

South Korea

References

Ahn JY, Lee J, Suh YS, Song YG, Choi YJ, Lee KH, Seo SH, Song M, Oh JW, Kim M, Seo HY, Kwak JE, Youn JW, Woo JW, Shin EC, Sung YC, Park SH, Choi JY. Safety and immunogenicity of two recombinant DNA COVID-19 vaccines containing the coding regions of the spike or spike and nucleocapsid proteins: an interim analysis of two open-label, non-randomised, phase 1 trials in healthy adults. Lancet Microbe. 2022 Mar;3(3):e173-e183. doi: 10.1016/S2666-5247(21)00358-X. Epub 2022 Feb 8.

Reference Type: DERIVED

PMID: 35156068 (View on PubMed)

Other Identifiers

GX-19N-HV-002

Identifier Type: -

Identifier Source: org_study_id