SARS-CoV-2Phase 1/2NCT04445389
Safety and Immunogenicity Study of GX-19, a COVID-19 Preventive DNA Vaccine in Healthy Adults
A Phase 1/2 study testing GX-19 and Saline in people with SARS-CoV-2, run by Genexine, Inc. at 1 site in South Korea.
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 50 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- GX-19 and Saline
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jun 2020to 17 Dec 2020
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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 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
- Being tested
- GX-19, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-19Drug
Also called DNA vaccine expressing SARS-CoV-2 S-protein antigen
DNA vaccine expressing SARS-CoV-2 S-protein antigen
SalineDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| GX-19: Dose A | Experimental | Dose A of GX-19 will be intramusculary administered via EP on day 1 and day 29. Receives: Drug: GX-19 |
| GX-19: Dose B | Experimental | Dose B of GX-19 will be intramusculary administered via EP on day 1 and day 29. Receives: Drug: GX-19 |
| GX-19: Dose C | Placebo comparator | Dose C of GX-19 will be intramusculary administered via PharmaJet® Needle Free Delivery on day 1 and day 29. Receives: Drug: GX-19 |
| Placebo: Dose A, B, or C | Placebo comparator | Placebo will be intramusculary administered on day 1 and day 29 via EP or PharmaJet® Needle Free Delivery Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of solicited adverse events
solicited local and systemic AEs after vaccination
Measured: Through 1 year post vaccination
Incidence of unsolicited adverse events
unsolicited AEs after vaccination
Measured: Through 1 year post vaccination
Incidence of serious adverse events
percentage of subjects with SAEs
Measured: Through 1 year post vaccination
Secondary outcomes (4)
Geometric mean titer (GMT) of antigen-specific binding antibody titers
Change from baseline in antigen-specific binding antibody titers
Measured: 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
Measured: 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
Measured: 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
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.
- First posted24 Jun 2020
- Study start17 Jun 2020
- Primary completion17 Dec 2020
- Study completion17 Dec 2020
Why it stopped: The sponsor decided to change the investigational product for a strategic reason.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Phase 1: Open-label, Dose escalation (3-arms) Phase 2a: Randomized, Double-blinded, Placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JungWon Woo, Ph.D., Study director, Genexine, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445389
- Sponsor's protocol ID
- GX-19-HV-001
- Status last verified
- Jan 2022
- First submitted
- 19 Jun 2020
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04445389
- Acronym / sponsor ID
- GX-19-HV-001
- Conditions
- SARS-CoV-2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor decided to change the investigational product for a strategic reason.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 24 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Phase 1: Open-label, Dose escalation (3-arms) Phase 2a: Randomized, Double-blinded, Placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| GX-19: Dose A | Experimental | Drug: GX-19Dose A of GX-19 will be intramusculary administered via EP on day 1 and day 29. |
| GX-19: Dose B | Experimental | Drug: GX-19Dose B of GX-19 will be intramusculary administered via EP on day 1 and day 29. |
| GX-19: Dose C | Placebo comparator | Drug: GX-19Dose C of GX-19 will be intramusculary administered via PharmaJet® Needle Free Delivery on day 1 and day 29. |
| Placebo: Dose A, B, or C | Placebo comparator | Drug: SalinePlacebo will be intramusculary administered on day 1 and day 29 via EP or PharmaJet® Needle Free Delivery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GX-19Also: DNA vaccine expressing SARS-CoV-2 S-protein antigenDNA vaccine expressing SARS-CoV-2 S-protein antigen | Drug | GX-19: Dose A, GX-19: Dose B, GX-19: Dose C |
| SalineSaline | Drug | Placebo: Dose A, B, or C |
Primary outcome
Incidence of solicited adverse events
Time frame: Through 1 year post vaccination
solicited local and systemic AEs after vaccination
Incidence of unsolicited adverse events
Time frame: Through 1 year post vaccination
unsolicited AEs after vaccination
Incidence of serious adverse events
Time frame: Through 1 year post vaccination
percentage of subjects with SAEs
4 secondary outcomes
Geometric mean titer (GMT) of antigen-specific binding antibody titers
Time frame: Through 1 year post vaccination
Percentage of subjects who seroconverted after vaccination
Time frame: Through 1 year post vaccination
Geometric mean titer (GMT) of neutralizing antibody level
Time frame: Through 1 year post vaccination
Geometric mean fold rise (GMFR) of antigen-specific binding antibody titers
Time frame: Through 1 year post vaccination
Results and safety
The study was stopped early (reason given: The sponsor decided to change the investigational product for a strategic reason.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JungWon Woo, Ph.D. study director
Genexine, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GX-19 and Saline in people with SARS-CoV-2, run by Genexine, Inc. at 1 site 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 5 inclusion and 21 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: stopped early, 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 1 site 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 was stopped early (reason given: The sponsor decided to change the investigational product for a strategic reason.). Results are not available in the source record.
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?
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.