SARS-CoV-2Phase 1NCT04915989
Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals
A Phase 1 study testing GX-19N in people with SARS-CoV-2, run by Genexine, Inc. at 2 sites in South Korea.
Trial summary
The objective of the study is to demonstrate safety and immunogenicity of COVID-19 preventive DNA vaccine in elderly individuals. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- GX-19N
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 16 Feb 2021to 1 Apr 2022
- Phase
- Phase 1
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able and willing to comply with all study procedures and voluntarily signs informed consent form
- Male or female aged 55-85 years
- Willing to provide specimens such as blood and urine during the study, including end of study visit.
Who cannot join
- Immunosuppression 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
Show all 19Show fewer
- 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 with significant chronic underlying diseases that may increase the risk of COVID-19 or interfere with the evaluation of clinical trial purposes according to the investigator's discretion
- 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
2 sites in 1 country.
South Korea2 sites
Severance hospital
Seoul, 03722
Gangnam Severance hospital
Seoul, 06273
About this study
Official title: A Phase 1, Multicenter, Open-Label, Single Arm Study to Investigate the Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals
The objective of the study is to demonstrate safety and immunogenicity of COVID-19 preventive DNA vaccine in elderly individuals.
Read the detailed description
This clinical study is a phase 1 clinical trial to investigate the safety and immunogenicity of COVID-19 preventive vaccine by intramuscularly administration in the elderly.
This study is designed as single arm, open-labeled and a total of 30 subjects will be enrolled.
- Conditions
- SARS-CoV-2
- Being tested
- GX-19N
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
| Study group | Role | What they receive |
|---|---|---|
| GX-19N | Experimental | Dose A of GX-19N will be intramuscularly administered via Electroporator(EP) on day 1 and day 29. (Optional administration on day 57) Receives: Drug: GX-19N |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Solicited Adverse Event(AE)s
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 Event(SAE)s
percentage of subjects with SAEs
Measured: Through 1 year post vaccination
Secondary outcomes (7)
GMT of Antigen-specific Binding Antibody Titers
Geometric mean titer (GMT) of antigen-specific binding antibody after vaccination
Measured: Through 12 weeks after vaccination
GMFR of Antigen-specific Binding Antibody Titers
Geometric mean fold rise (GMFR) of antigen-specific binding antibody after vaccination
Measured: Through 12 weeks after vaccination
Percentage of Subjects Who Seroconverted After Vaccination
Seroconversion defines as 4-fold increase in antibody titer after vaccination
Measured: Through 12 weeks after vaccination
GMT of Neutralizing Antibody Level
Geometric mean titer (GMT) of neutralizing antibody after vaccination
Measured: Through 12 weeks after vaccination
GMFR of Neutralizing Antibody Level
Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination
Measured: Through 12 weeks after vaccination
GMSN of Spot Forming Unit (SFU) detected by interferon(IFN)-gamma ELISPOT assay
Geometric mean spot numbers (GMSN) of SFU after vaccination
Measured: Through 12 weeks after vaccination
GMFR of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay
Geometric mean fold rise (GMFR) of SFU after vaccination
Measured: Through 12 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start16 Feb 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Yong Choi, MD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915989
- Sponsor's protocol ID
- GX-19N-HV-003
- Status last verified
- Feb 2024
- First submitted
- 3 Jun 2021
- Last updated
- 1 Mar 2024
- Results posted
- No
- 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label, Single Arm Study to Investigate the Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals
- ClinicalTrials.gov ID
- NCT04915989
- Acronym / sponsor ID
- GX-19N-HV-003
- Conditions
- SARS-CoV-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 7 Jun 2021 (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 the study is to demonstrate safety and immunogenicity of COVID-19 preventive DNA vaccine in elderly individuals.
Detailed description
This clinical study is a phase 1 clinical trial to investigate the safety and immunogenicity of COVID-19 preventive vaccine by intramuscularly administration in the elderly.
This study is designed as single arm, open-labeled and a total of 30 subjects will be enrolled.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GX-19N | Experimental | Drug: GX-19NDose A of GX-19N will be intramuscularly administered via Electroporator(EP) on day 1 and day 29. (Optional administration on day 57) |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able and willing to comply with all study procedures and voluntarily signs informed consent form
- Male or female aged 55-85 years
- Willing to provide specimens such as blood and urine during the study, including end of study visit.
Key exclusion criteria (19 listed)
- Immunosuppression 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
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-19NAlso: Dose ADNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen | Drug | GX-19N |
Primary outcome
Incidence of Solicited Adverse Event(AE)s
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 Event(SAE)s
Time frame: Through 1 year post vaccination
percentage of subjects with SAEs
7 secondary outcomes
GMT of Antigen-specific Binding Antibody Titers
Time frame: Through 12 weeks after vaccination
GMFR of Antigen-specific Binding Antibody Titers
Time frame: Through 12 weeks after vaccination
Percentage of Subjects Who Seroconverted After Vaccination
Time frame: Through 12 weeks after vaccination
GMT of Neutralizing Antibody Level
Time frame: Through 12 weeks after vaccination
GMFR of Neutralizing Antibody Level
Time frame: Through 12 weeks after vaccination
GMSN of Spot Forming Unit (SFU) detected by interferon(IFN)-gamma ELISPOT assay
Time frame: Through 12 weeks after vaccination
GMFR of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay
Time frame: Through 12 weeks after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- 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.
Jun Yong Choi, MD principal investigator
Severance Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GX-19N in people with SARS-CoV-2, run by Genexine, Inc. at 2 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 19 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 Event(AE)s (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 1 Mar 2024.