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

NCT04715997 | Completed Phase 1 DMC

• 1 other identifier: GX-19N-HV-002
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• GMT of Antigen-specific Binding Antibody Titers

  Through 1 year post vaccination

• GMFR of Antigen-specific Binding Antibody Titers

  Through 1 year post vaccination

• Percentage of Subjects Who Seroconverted After Vaccination

  Through 1 year post vaccination

• GMT and GMFR of Neutralizing Antibody Level

  Through 1 year post vaccination

• GMFR of Neutralizing Antibody Level

  Through 1 year post vaccination

Other Outcomes (1)

• Change From Baseline in Antigen-specific IFN-gamma Cellular Immune Response

  Through 1 year post vaccination

Study Arms (2)

GX-19: Dose A

EXPERIMENTAL

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

Drug: GX-19N

Placebo: Normal saline

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

GX-19N DRUG

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

Also known as: Dose A

GX-19: Dose A

Placebo DRUG

Normal saline

Also known as: Normal saline

Placebo: Normal saline

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (5)

KyungHee University Medical Center

Seoul, 02447, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Hanyang University Hospital

Seoul, 04763, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Related Publications (1)

• 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.

  PMID: 35156068 DERIVED

MeSH Terms

Interventions

GX-19N vaccine; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• JungWon Woo, Ph.D.

  Genexine, Inc.

  STUDY DIRECTOR

• Jun Yong Choi, MD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 20, 2021
• Study Start: December 30, 2020
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2022
• Last Updated: August 20, 2025

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)