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SARS-CoV-2Phase 1/2NCT04715997

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

A Phase 1/2 study testing GX-19N in people with SARS-CoV-2, run by Genexine, Inc. at 5 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2
What is being tested?
GX-19N
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
185 participants
Where
5 sitesSouth Korea
Study dates
30 Dec 2020to 19 Apr 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

South Korea5 sites

  • KyungHee University Medical Center

    Seoul, 02447

  • Severance Hospital

    Seoul, 03722

  • Hanyang University Hospital

    Seoul, 04763

  • Gangnam Severance Hospital

    Seoul, 06273

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

About this study

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

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

Read the 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
Being tested
GX-19N, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GX-19NDrug

    Also called Dose A

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

  • PlaceboDrug

    Also called Normal saline

    Normal saline

Study groups in NCT04715997
Study groupRoleWhat they receive
GX-19: Dose AExperimentalDose A of GX-19N will be intramusculary administered via EP on day 1 and day 29.
Receives: Drug: GX-19N
Placebo: Normal salinePlacebo comparatorPlacebo will be intramusculary administered via EP on day 1 and day 29.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Solicited Adverse Events

    solicited local and systemic AEs after vaccination

    Measured: Through 1 year post vaccination

  2. Incidence of Unsolicited Adverse Events

    unsolicited AEs after vaccination

    Measured: Through 1 year post vaccination

  3. Incidence of Serious Adverse Events

    percentage of subjects with SAEs

    Measured: Through 1 year post vaccination

Secondary outcomes (6)

  1. GMT of Antigen-specific Binding Antibody Titers

    Geometric mean titer (GMT) of antigen-specific binding antibody after vaccination

    Measured: Through 1 year post vaccination

  2. GMFR of Antigen-specific Binding Antibody Titers

    Geometric mean fold rise (GMFR) of antigen-specific binding antibody after vaccination

    Measured: Through 1 year post vaccination

  3. Percentage of Subjects Who Seroconverted After Vaccination

    Seroconversion defines when FRNT50 is detected more than four times from the baseline after vaccination

    Measured: Through 1 year post vaccination

  4. GMT and GMFR of Neutralizing Antibody Level

    Geometric mean titer (GMT) and Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination

    Measured: Through 1 year post vaccination

  5. GMFR of Neutralizing Antibody Level

    Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination

    Measured: Through 1 year post vaccination

  6. 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

    Measured: Through 1 year post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2021
  2. Study start30 Dec 2020
  3. Primary completion19 Apr 2022
  4. Study completion19 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04715997
Sponsor's protocol ID
GX-19N-HV-002
Status last verified
Nov 2022
First submitted
18 Jan 2021
Last updated
20 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35156068

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GX-19N in people with SARS-CoV-2, run by Genexine, Inc. at 5 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Solicited Adverse Events (time frame: Through 1 year post vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04715997, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.

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