SARS-CoV2 InfectionPhase 2/3NCT05067946
Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines
A Phase 2/3 study testing GX-19N in people with SARS-CoV2 Infection, run by Genexine, Inc..
Trial summary
The purpose of this study is to evaluate the efficacy, safety and immunogenicity of GX-19N in healthy individuals who have received one of COVID-19 vaccine authorized for emergency use. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Oct 2023
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult males or females aged 18 years and above at the time of consent
- Healthy subjects in normal medical condition as determined by medical history, physical examination, and investigator's discretion
- Have previously received homologous full-dose of COVID-19 vaccine authorized for emergency use, and at least 3 months post second vaccination prior to Day 1
- Negative results for SARS-COV-2 rapid antigen test at the screening period
- Able to comply with all study procedures and requirements
- Agree for blood and nasal swab samples could be collected throughout the study period, including surveillance visit
Who cannot join
- Unable to follow clinical and follow-up procedures
- Acute fever with temperature above 38℃, coughing, breathing difficulty, chills, muscle ache, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to the vaccination
- History of SARS-CoV-2 infection or have experienced prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine
- History of a malignant disease within the past 5 years
- Immune dysfunction, including immunodeficiency disorder, or family history of such conditions (Except stable/well-controlled HIV-positive participants)
- Have received immunoglobulin or blood-derived products within 3 months prior to the vaccination or are scheduled to receive them during the study period
Show all 18Show fewer
- Have been dependent on antipsychotic drugs and narcotic analgesics within 6 months prior to the vaccination
- History or are suspected of alcohol or drug dependency
- History of hypersensitivity or allergic reactions including anaphylaxis
- A current or history of clinically significant chronic cardiovascular, endocrine, gastrointestinal, hepatic (including hepatitis B and C), renal, neurological, respiratory, psychiatric or other medical disorders not excluded by other exclusion criteria, that are assessed by the investigator
- Hemophiliacs or people using anticoagulants who are at a risk of serious bleeding from IM injection
- Have received or plans to receive other vaccination(s) within 28 days prior to or during study duration (except for influenza vaccine which is not allowed within 14 days before, or 4 weeks after final dose of IP)
- Have taken an immunosuppressant or immune-modifying drug within 3 months prior to the vaccination; chronic administration (defined as more than 14 continuous days) of immunosuppressant medication within the past 3 months, except topical steroids or short-term oral steroids (course lasting ≤ 14 days)
- Female who are pregnant or breastfeeding; however, participation is possible if breastfeeding is discontinued prior to participation in the study
- Have received or have plans to receive other investigational drug(s) while participating in another clinical study or bioequivalence study within 28 days prior to vaccination
- Not consent to the use of effective contraception at least 90 days after the last vaccination
- Lack of acceptable sites available for IM injection and EP
- Deemed ineligible by the investigator based on other clinically significant medical or psychiatric findings
About this study
Official title: A Phase 2/3, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of GX-19N, A DNA Vaccine, in Healthy Individuals Who Have Received One of the COVID-19 Vaccines
The purpose of this study is to evaluate the efficacy, safety and immunogenicity of GX-19N in healthy individuals who have received one of COVID-19 vaccine authorized for emergency use.
- Conditions
- SARS-CoV2 Infection
- Being tested
- GX-19N, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-19NBiological
DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen
PlaceboOther
GX-19N formulation buffer
| Study group | Role | What they receive |
|---|---|---|
| GX-19N | Experimental | GX-19N will be intramusculary administered via EP on day 1 and day 29. Receives: Biological: GX-19N |
| Placebo | Placebo comparator | Placebo will be intramusculary administered via EP on day 1 and day 29 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
First occurrence of COVID-19 at least 14 days after the second vaccination
Symptomatic, virologically confirmed COVID-19 as described in the study
Measured: Up to 1 year after first vaccination
Incidence of severe solicited adverse events (AEs)
Percentage of subjects reporting grade 3 or higher AEs after each vaccination
Measured: Up to 7 days after each vaccination
Incidence of AEs and Serious AEs (SAEs) after each vaccination
Percentage of subjects reporting AEs and SAEs after each vaccination
Measured: Up to 1 month after each vaccination
Incidence of SAE, and Adverse events of special interest (AESIs), which relevant to COVID-19 including possible vaccine-enhanced disease
SAE and AESIs reported in all subjects at any time after the first vaccination
Measured: Up to 1 year after first vaccination
Secondary outcomes (3)
First occurrence of severe COVID-19 at least 14 days after the second vaccination
Symptomatic, virologically confirmed severe COVID-19 as described in the study
Measured: Up to 1 year after first vaccination
Cell-mediated immune responses after vaccination
Antigen-specific T cell response in a subset of Phase 2/3
Measured: Up to 1 year after first vaccination
Antibody responses after vaccination
Analysis of binding antibodies and neutralizing antibodies in a subset of Phase 2/3
Measured: Up to 1 year after first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: Change of development strategy in consideration of the global COVID-19 situation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PT Kalbe Farma Tbk
- Responsible party
- Sponsor
- Investigators
- JungWon Woo, Ph.D., Study director, Genexine, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067946
- Sponsor's protocol ID
- GX-19N-HV-004
- Status last verified
- Jul 2021
- First submitted
- 4 Oct 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of GX-19N, A DNA Vaccine, in Healthy Individuals Who Have Received One of the COVID-19 Vaccines
- ClinicalTrials.gov ID
- NCT05067946
- Acronym / sponsor ID
- GX-19N-HV-004
- Conditions
- SARS-CoV2 Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change of development strategy in consideration of the global COVID-19 situation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PT Kalbe Farma Tbk
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 5 Oct 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 purpose of this study is to evaluate the efficacy, safety and immunogenicity of GX-19N in healthy individuals who have received one of COVID-19 vaccine authorized for emergency use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GX-19N | Experimental | Biological: GX-19NGX-19N will be intramusculary administered via EP on day 1 and day 29. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo will be intramusculary administered via EP on day 1 and day 29 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult males or females aged 18 years and above at the time of consent
- Healthy subjects in normal medical condition as determined by medical history, physical examination, and investigator's discretion
- Have previously received homologous full-dose of COVID-19 vaccine authorized for emergency use, and at least 3 months post second vaccination prior to Day 1
- Negative results for SARS-COV-2 rapid antigen test at the screening period
- Able to comply with all study procedures and requirements
Key exclusion criteria (18 listed)
- Unable to follow clinical and follow-up procedures
- Acute fever with temperature above 38℃, coughing, breathing difficulty, chills, muscle ache, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to the vaccination
- History of SARS-CoV-2 infection or have experienced prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine
- History of a malignant disease within the past 5 years
- Immune dysfunction, including immunodeficiency disorder, or family history of such conditions (Except stable/well-controlled HIV-positive participants)
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-19NDNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen | Biological | GX-19N |
| PlaceboGX-19N formulation buffer | Other | Placebo |
Primary outcome
First occurrence of COVID-19 at least 14 days after the second vaccination
Time frame: Up to 1 year after first vaccination
Symptomatic, virologically confirmed COVID-19 as described in the study
Incidence of severe solicited adverse events (AEs)
Time frame: Up to 7 days after each vaccination
Percentage of subjects reporting grade 3 or higher AEs after each vaccination
Incidence of AEs and Serious AEs (SAEs) after each vaccination
Time frame: Up to 1 month after each vaccination
Percentage of subjects reporting AEs and SAEs after each vaccination
Incidence of SAE, and Adverse events of special interest (AESIs), which relevant to COVID-19 including possible vaccine-enhanced disease
Time frame: Up to 1 year after first vaccination
SAE and AESIs reported in all subjects at any time after the first vaccination
3 secondary outcomes
First occurrence of severe COVID-19 at least 14 days after the second vaccination
Time frame: Up to 1 year after first vaccination
Cell-mediated immune responses after vaccination
Time frame: Up to 1 year after first vaccination
Antibody responses after vaccination
Time frame: Up to 1 year after first vaccination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GX-19N in people with SARS-CoV2 Infection, run by Genexine, Inc..
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 6 inclusion and 18 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: withdrawn, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
First occurrence of COVID-19 at least 14 days after the second vaccination (time frame: Up to 1 year after first vaccination). The study lists 4 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 12 Apr 2022.