<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04445389</url>
  </required_header>
  <id_info>
    <org_study_id>GX-19-HV-001</org_study_id>
    <nct_id>NCT04445389</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity Study of GX-19, a COVID-19 Preventive DNA Vaccine in Healthy Adults</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genexine, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Genexine, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of our study is to evaluate safety, tolerability, and immunogenicity of&#xD;
      COVID-19 preventive DNA vaccine in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical study is phase 1/2a clinical trial to evaluate safety, tolerability, and&#xD;
      immunogenicity of COVID-19 preventive vaccine by intramuscularly administration in healthy&#xD;
      volunteers.&#xD;
&#xD;
      Phase 1 of this study is designed as dose escaltion, single arm, open-labeled and a total of&#xD;
      60 subjects will be enrolled. Phase 2a of study is designed as randomized, double-blind,&#xD;
      placebo controlled and a total of 150 subjects are planned to be enrolled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Anticipated">March 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Phase 1: Open-label, Dose escalation (3-arms) Phase 2a: Randomized, Double-blinded, Placebo-controlled</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of solicited adverse events</measure>
    <time_frame>Through 1 year post vaccination</time_frame>
    <description>solicited local and systemic AEs after vaccination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of unsolicited adverse events</measure>
    <time_frame>Through 1 year post vaccination</time_frame>
    <description>unsolicited AEs after vaccination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of serious adverse events</measure>
    <time_frame>Through 1 year post vaccination</time_frame>
    <description>percentage of subjects with SAEs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric mean titer (GMT) of antigen-specific binding antibody titers</measure>
    <time_frame>Through 1 year post vaccination</time_frame>
    <description>Change from baseline in antigen-specific binding antibody titers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects who seroconverted after vaccination</measure>
    <time_frame>Through 1 year post vaccination</time_frame>
    <description>Seroconversion rate can be calculated based on test results reaching the quantifiable antibody level after vaccination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric mean titer (GMT) of neutralizing antibody level</measure>
    <time_frame>Through 1 year post vaccination</time_frame>
    <description>NAb is regarded as produced when FRNT50 is detected more than four times the baseline after vaccination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric mean fold rise (GMFR) of antigen-specific binding antibody titers</measure>
    <time_frame>Through 1 year post vaccination</time_frame>
    <description>Change from baseline in antigen-specific binding antibody titers</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in antigen-specific IFN-g cellular immune response</measure>
    <time_frame>Through 1 year post vaccination</time_frame>
    <description>Antigen-specific IFN-γ T cell immune response assessed before/after vaccination</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>SARS-CoV-2</condition>
  <arm_group>
    <arm_group_label>GX-19: Dose A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose A of GX-19 will be intramusculary administered via EP on day 1 and day 29.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GX-19: Dose B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose B of GX-19 will be intramusculary administered via EP on day 1 and day 29.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GX-19: Dose C</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Dose C of GX-19 will be intramusculary administered via PharmaJet® Needle Free Delivery on day 1 and day 29.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo: Dose A, B, or C</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be intramusculary administered on day 1 and day 29 via EP or PharmaJet® Needle Free Delivery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GX-19</intervention_name>
    <description>DNA vaccine expressing SARS-CoV-2 S-protein antigen</description>
    <arm_group_label>GX-19: Dose A</arm_group_label>
    <arm_group_label>GX-19: Dose B</arm_group_label>
    <arm_group_label>GX-19: Dose C</arm_group_label>
    <other_name>DNA vaccine expressing SARS-CoV-2 S-protein antigen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Saline</description>
    <arm_group_label>Placebo: Dose A, B, or C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Each participant must meet all of the following criteria during the screening period:&#xD;
&#xD;
          1. Able and willing to comply with all study procedures and voluntarily signs informed&#xD;
             consent form&#xD;
&#xD;
          2. Healthy adult male or female aged 19-50 years&#xD;
&#xD;
          3. Those who weigh 50 kg to 90kg and have a body mass index (BMI) of 18.0 kg/m2 to 28.0&#xD;
             kg/m2 at screening visit.&#xD;
&#xD;
          4. Willing to provide specimens such as blood and urine during the study, including end&#xD;
             of study visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants meeting any of the following criteria at the Screening Visit:&#xD;
&#xD;
          1. Immunosuppresion including immunodeficiency disease or family history&#xD;
&#xD;
          2. Any history of malignant disease within the past 5 years&#xD;
&#xD;
          3. Scheduled to undergo any surgery or dental treatment during the study&#xD;
&#xD;
          4. Having received immunoglobulin or blood-derived drugs or being expected to be&#xD;
             administered within 3 months prior to administration.&#xD;
&#xD;
          5. Having relied on antipsychotic drugs and narcotic analgesics within 6 months before&#xD;
             administration&#xD;
&#xD;
          6. Positive of serum test at screening&#xD;
&#xD;
          7. Suspected of drug abuse or a history within 12 months prior to administration&#xD;
&#xD;
          8. Active alcohol use or history of alcohol abuse&#xD;
&#xD;
          9. Serious adverse reaction to a drug containing GX-19 or other ingredients of the same&#xD;
             categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease&#xD;
             control, etc. or an allergic history&#xD;
&#xD;
         10. History of hypersensitivity to vaccination such as Guillain-Barre syndrome&#xD;
&#xD;
         11. Those who have or with a history of disease corresponding to other hepatobiliary,&#xD;
             kidneys, nervous systems (middle or peripheral), respiratory machines (e.g. asthma,&#xD;
             pneumonia, etc., endocrine systems (uncontrolled diabetes, hyperlipidemia, etc.) and&#xD;
             cardiovascular (congestive heart failure, coronary artery disease, myocardial&#xD;
             infarction, uncontrolled hypertension), blood tumors, urinary machines, mental,&#xD;
             musculoskeletal systems, immune system (rheumatoid arthritis, systemic arthritis,&#xD;
             mumps, immunodeficiency disease)&#xD;
&#xD;
         12. Having hemophilia at risk of causing serious bleeding when injected intramuscularly or&#xD;
             receiving anticoagulants&#xD;
&#xD;
         13. Subjects who have been contact with COVID-19 infections in the past prior to&#xD;
             administration, have been classified as COVID-19 confirmed patients, medical patients&#xD;
             or patients with symptoms or have been identified with SARS and MERS infection history&#xD;
             in the past&#xD;
&#xD;
         14. Acute fever, cough, difficulty breathing, chills, muscle aches, headache, sore throat,&#xD;
             loss of smell, or loss of taste within 72 hours prior to administration&#xD;
&#xD;
         15. Other vaccination history within 28 days prior to the administration or being&#xD;
             scheduled to be inoculated during the study&#xD;
&#xD;
         16. History of having taken immunosuppressant or Immune modifying drug within 3 months&#xD;
             prior to administration&#xD;
&#xD;
         17. Having participated and had clinical trial drug administration in another clinical&#xD;
             trial or biological equivalence study within 6 months prior to the administration&#xD;
&#xD;
         18. Pregnant or breastfeeding female, however, those are allowed to participate in the&#xD;
             study only if they stop breastfeeding before participation (fertile female† must be&#xD;
             negative in serum pregnancy test at screening&#xD;
&#xD;
         19. Fertile female who do not agree to use effective contraception methods (condoms,&#xD;
             contraceptive diaphragm, intrauterine contraceptive devices) during the study&#xD;
&#xD;
         20. Any other clinically significant medical or psychiatric finding which is considered&#xD;
             inappropriate by investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JungWon Woo, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Genexine, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Severance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>November 25, 2021</last_update_submitted>
  <last_update_submitted_qc>November 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04445389
org study id: GX-19-HV-001
nct id: NCT04445389
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of our study is to evaluate safety, tolerability, and immunogenicity of
      COVID-19 preventive DNA vaccine in healthy volunteers.
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.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Phase 1: Open-label, Dose escalation (3-arms) Phase 2a: Randomized, Double-blinded, Placebo-controlled
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Incidence of solicited adverse events
time frame: Through 1 year post vaccination
description: solicited local and systemic AEs after vaccination
measure: Incidence of unsolicited adverse events
time frame: Through 1 year post vaccination
description: unsolicited AEs after vaccination
measure: Incidence of serious adverse events
time frame: Through 1 year post vaccination
description: percentage of subjects with SAEs
measure: Geometric mean titer (GMT) of antigen-specific binding antibody titers
time frame: Through 1 year post vaccination
description: Change from baseline in antigen-specific binding antibody titers
measure: Percentage of subjects who seroconverted after vaccination
time frame: Through 1 year post vaccination
description: Seroconversion rate can be calculated based on test results reaching the quantifiable antibody level after vaccination
measure: Geometric mean titer (GMT) of neutralizing antibody level
time frame: Through 1 year post vaccination
description: NAb is regarded as produced when FRNT50 is detected more than four times the baseline after vaccination
measure: Geometric mean fold rise (GMFR) of antigen-specific binding antibody titers
time frame: Through 1 year post vaccination
description: Change from baseline in antigen-specific binding antibody titers
measure: Change from baseline in antigen-specific IFN-g cellular immune response
time frame: Through 1 year post vaccination
description: Antigen-specific IFN-γ T cell immune response assessed before/after vaccination
arm group label: GX-19: Dose A
arm group type: Experimental
description: Dose A of GX-19 will be intramusculary administered via EP on day 1 and day 29.
arm group label: GX-19: Dose B
arm group type: Experimental
description: Dose B of GX-19 will be intramusculary administered via EP on day 1 and day 29.
arm group label: GX-19: Dose C
arm group type: Placebo Comparator
description: Dose C of GX-19 will be intramusculary administered via PharmaJet® Needle Free Delivery on day 1 and day 29.
arm group label: Placebo: Dose A, B, or C
arm group type: Placebo Comparator
description: Placebo will be intramusculary administered on day 1 and day 29 via EP or PharmaJet® Needle Free Delivery
intervention type: Drug
intervention name: GX-19
description: DNA vaccine expressing SARS-CoV-2 S-protein antigen
arm group label: GX-19: Dose A
arm group label: GX-19: Dose B
arm group label: GX-19: Dose C
other name: DNA vaccine expressing SARS-CoV-2 S-protein antigen
intervention type: Drug
intervention name: Saline
description: Saline
arm group label: Placebo: Dose A, B, or C
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: JungWon Woo, Ph.D.
role: Study Director
affiliation: Genexine, Inc.
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Vaccines
sharing ipd: No