<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/NCT04463472</url>
  </required_header>
  <id_info>
    <org_study_id>AG0301-COVID19-JN-01</org_study_id>
    <nct_id>NCT04463472</nct_id>
  </id_info>
  <brief_title>Study of COVID-19 DNA Vaccine (AG0301-COVID19)</brief_title>
  <official_title>A Non-randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Two Doses of Intramuscular AG0301-COVID19 (1mg/2mg) in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AnGes, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Japan Agency for Medical Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AnGes, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult&#xD;
      volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1/2, single-center, non-randomised, open-label, non-controlled trial.&#xD;
      Approximately 30 healthy volunteers, male or female, aged 20-65, will be enrolled in the low&#xD;
      dose group for the first 15 and the high dose group for the remaining 15.&#xD;
&#xD;
      Low dose group: 1.0 mg AG0301-COVID19 intramuscular (IM) (n = 15) High dose group: 2.0 mg&#xD;
      AG0301-COVID19 IM (n = 15)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Actual">August 12, 2021</completion_date>
  <primary_completion_date type="Actual">September 28, 2020</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>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>Week 1 through Week 9</time_frame>
    <description>Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after first vaccination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>Weeks 3, 5, 7, 9</time_frame>
    <description>Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in GMT of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody</measure>
    <time_frame>Weeks 13, 25, 53</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody</measure>
    <time_frame>Weeks 3, 5, 7, 9, 13, 25, 53</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in GMT of anti-SARS-CoV-2 B cell epitope antibody</measure>
    <time_frame>Weeks 3, 5, 7, 9, 13, 25, 53</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody</measure>
    <time_frame>Weeks 3, 5, 7, 9, 13, 25, 53</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Week 9 through Week 53</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Low-dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High-dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AG0301-COVID19</intervention_name>
    <description>1.0 mg of AG0301-COVID19 twice at 2-week intervals</description>
    <arm_group_label>Low-dose group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AG0301-COVID19</intervention_name>
    <description>2.0 mg of AG0301-COVID19 twice at 2-week intervals</description>
    <arm_group_label>High-dose group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who have obtained written consent voluntarily to participate in this clinical&#xD;
             trial&#xD;
&#xD;
          2. Subjects whose age at the time of obtaining consent is 20 years to 65 years&#xD;
&#xD;
          3. Subjects who are negative for SARS-CoV-2 by PCR test&#xD;
&#xD;
          4. Subjects who are negative for both SARS-CoV-2 IgM antibody and SARS-CoV-2 IgG antibody&#xD;
             by antibody test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with symptoms of suspected COVID-19 infection (respiratory symptoms,&#xD;
             headache, malaise, olfactory disorders, taste disorders, etc.)&#xD;
&#xD;
          2. Subjects with a history of COVID-19 (hearing from subjects)&#xD;
&#xD;
          3. Subjects who have participated in unapproved vaccine clinical trials&#xD;
&#xD;
          4. Subjects with axillary temperature of 37.0 degree or higher&#xD;
&#xD;
          5. Subjects who have a history of anaphylaxis&#xD;
&#xD;
          6. Subjects who have serious renal, liquid, respiratory, liver, kidney, digestive, and&#xD;
             neuropsychiatric history has a current medical history&#xD;
&#xD;
          7. Subjects with a history of convulsion or epilepsy&#xD;
&#xD;
          8. Subjects with a history of diagnosis of immunodeficiency&#xD;
&#xD;
          9. Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency&#xD;
&#xD;
         10. Subjects who have a history of bronchial asthma&#xD;
&#xD;
         11. Subjects who had a fever of 39.0°C or higher within 2 days after the last vaccination,&#xD;
             and those who suspected allergy such as a systemic rash&#xD;
&#xD;
         12. Females who wish to become pregnant from the date of study registration to 12 weeks&#xD;
             after the first inoculation of the investigational drug, and pregnant females who are&#xD;
             breast-feeding. In addition, females who may become pregnant and their male sexual&#xD;
             partners should use appropriate contraceptives (pill), condoms, vasectomy, tubal&#xD;
             ligation, diaphragm, intrauterine devices, spermicides, intrauterine hormone-releasing&#xD;
             system, etc. from the study entry date until 12 weeks after vaccination&#xD;
&#xD;
         13. Subjects who have participated in clinical trials of other unapproved drugs and&#xD;
             received the investigational drug within 4 weeks before the start of this clinical&#xD;
             trial (starting from vaccination day)&#xD;
&#xD;
         14. Subjects who have been received a live vaccine, inactivated vaccine, or toxoid within&#xD;
             4 weeks before the start of this clinical trial (starting from vaccination day)&#xD;
&#xD;
         15. Subjects who have been administered with drugs that affect the immune system&#xD;
             (excluding external preparations) such as immunomodulators (DMARDs, etc.),&#xD;
             immunosuppressants, biologics, etc. within 4 weeks from vaccination&#xD;
&#xD;
         16. Subjects who received blood transfusion or gamma globulin therapy within 12 week&#xD;
             before vaccination, or high-dose gamma globulin therapy (200 mg/kg or more) within 24&#xD;
             weeks before vaccination&#xD;
&#xD;
         17. Subjects who have a history of overseas travel within 4 weeks before the start of the&#xD;
             clinical trial (starting from vaccination day)&#xD;
&#xD;
         18. Subjects who are unable to comply with the clinical trial protocol and follow up (for&#xD;
             mental, family, social or geographical reasons)&#xD;
&#xD;
         19. Subjects who are judged to be ineligible for this clinical trial by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AnGes, Inc. Clinical Development</last_name>
    <role>Study Director</role>
    <affiliation>AnGes, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Osaka City University Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vaccine</keyword>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_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/NCT04463472
org study id: AG0301-COVID19-JN-01
nct id: NCT04463472
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult
      volunteers.
This is a Phase 1/2, single-center, non-randomised, open-label, non-controlled trial.
      Approximately 30 healthy volunteers, male or female, aged 20-65, will be enrolled in the low
      dose group for the first 15 and the high dose group for the remaining 15.

      Low dose group: 1.0 mg AG0301-COVID19 intramuscular (IM) (n = 15) High dose group: 2.0 mg
      AG0301-COVID19 IM (n = 15)
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: Week 1 through Week 9
description: Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after first vaccination
measure: Immunogenicity
time frame: Weeks 3, 5, 7, 9
description: Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
measure: Change in GMT of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
time frame: Weeks 13, 25, 53
measure: Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody
time frame: Weeks 3, 5, 7, 9, 13, 25, 53
measure: Change in GMT of anti-SARS-CoV-2 B cell epitope antibody
time frame: Weeks 3, 5, 7, 9, 13, 25, 53
measure: Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
time frame: Weeks 3, 5, 7, 9, 13, 25, 53
measure: Adverse events
time frame: Week 9 through Week 53
arm group label: Low-dose group
arm group type: Experimental
arm group label: High-dose group
arm group type: Experimental
intervention type: Biological
intervention name: AG0301-COVID19
description: 1.0 mg of AG0301-COVID19 twice at 2-week intervals
arm group label: Low-dose group
intervention type: Biological
intervention name: AG0301-COVID19
description: 2.0 mg of AG0301-COVID19 twice at 2-week intervals
arm group label: High-dose group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: AnGes, Inc. Clinical Development
role: Study Director
affiliation: AnGes, Inc.
facility: 
country: Japan
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No