<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/NCT04447781</url>
  </required_header>
  <id_info>
    <org_study_id>IVI COVID19-001</org_study_id>
    <nct_id>NCT04447781</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Immunogenicity of INO-4800 Followed by Electroporation in Healthy Volunteers for COVID19</brief_title>
  <official_title>A Phase I/IIa, Dose-Ranging Trial to Evaluate Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Vaccine Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Coalition for Epidemic Preparedness Innovations</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Inovio Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>International Vaccine Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase I/IIa trial to evaluate the safety, tolerability and immunological profile of&#xD;
      INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using&#xD;
      the CELLECTRA® 2000 device in healthy adults aged 19 to 64 years in Republic of Korea. INO-&#xD;
      4800 contains the plasmid pGX9501, which encodes for the full length of the Spike&#xD;
      glycoprotein of SARS-CoV-2. The primary objective of this trial is to evaluate the&#xD;
      tolerability, safety, and immunogenicity of INO-4800 administered by ID injection followed by&#xD;
      EP in healthy adults in the Part A and Part B. Enrollment into Part A, and Part B will&#xD;
      proceed sequentially.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      [Part A] Part A is open-label, dose-ranging study, enrolling total of 40 subjects. Part A is&#xD;
      divided into two arm, low dose (Group 1) and high dose (Group 2). The subjects will be&#xD;
      contacted by telephone to report adverse events or other reactions the day following the&#xD;
      first vaccination. Once these first five subjects in Group 1 complete the Week 1 visit, all&#xD;
      available clinical laboratory and adverse event data will be reviewed by the Data Safety&#xD;
      Monitoring Board (DSMB). Further enrollment into Group 1 will be paused during this DSMB&#xD;
      review. If DSMB determines there are no safety findings judged to be of clinical concern and&#xD;
      no dose limiting toxicities nor any stopping events observed, enrollment will be opened for&#xD;
      the remaining subjects in Group 1. Once Group 1 enrollment is completed [i.e., 20 total&#xD;
      subjects enrolled], Group 2 will open to enrollment. Daily safety assessment of all enrolled&#xD;
      subjects will be supported by the Study Medical Monitor on an ongoing basis while the first&#xD;
      five subjects are being enrolled, if needed. The subjects will be contacted by telephone to&#xD;
      report adverse events or other reactions the day following the first vaccination. Once the&#xD;
      first five subjects Group 2 complete the Week 1 visit, all available clinical laboratory and&#xD;
      adverse event data from these first five subjects, along with the safety data from subjects&#xD;
      in Group 1, will be reviewed by the DSMB. However, enrollment may continue while this DSMB&#xD;
      review is conducted, without any pause to enrollment of the remaining subjects in Group 2.&#xD;
&#xD;
      Once all subjects in Part A Group 1 and Group 2 complete the Week 8 visit, all available&#xD;
      clinical laboratory, adverse event, immunogenicity data from all subjects will be reviewed by&#xD;
      the DSMB. The DSMB will additionally review serious adverse events (SAEs) and adverse events&#xD;
      of special interest (AESIs) date throughout the study. With DSMB's recommendation, the&#xD;
      optimal dose for Part B will be selected by the Sponsor based on the following criteria which&#xD;
      may be adjusted over the course of the study. Percentage immunogenic seroconversionRelative&#xD;
      immunogenicity between INO-4800 Study Arms (Low dose vs. High dose)Safety profile of each&#xD;
      INO-4800 Study Arms (Low dose vs. High dose). All subjects will be followed for 48 weeks&#xD;
      following the 2nd vaccination. Week 52 will be the End of Study (EOS) visit.&#xD;
&#xD;
      [Part B] Part B is divided into two arm, IP Arm (Group 3) and Placebo Arm (Group 4). Part B&#xD;
      will be randomized, double-blind, placebo-controlled trial, enrolling 60 subjects in IP arm,&#xD;
      and 20 subjects in Placebo arm in 19-50 age group, and 30 subjects in IP arm, and 10 subjects&#xD;
      in Placebo arm in 51-64 age group, for total of 90 subjects in IP arm, and 30 subjects in&#xD;
      Placebo arm. At dosing visit, subjects will be randomized to either Group 3 or Group 4. The&#xD;
      subjects will be contacted by telephone to report adverse events or other reactions the day&#xD;
      following the first vaccination. DSMB review of safety findings will be performed according&#xD;
      to the DSMB charter. All subjects will be followed for 48 weeks following the 2nd&#xD;
      vaccination. Week 52 will be the End of Study (EOS) visit.Should the criteria for any dose&#xD;
      limiting toxicity or stopping rule be met, at any time, further enrollment and administration&#xD;
      of INO-4800 will be paused for further evaluation. The Sponsor will consult the DSMB, if&#xD;
      needed, to determine whether to enroll and/or dose the remainder of the subjects. All&#xD;
      subjects will be followed for 48 weeks following the 2nd vaccination. Week 52 will be the End&#xD;
      of Study (EOS) visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">May 25, 2022</completion_date>
  <primary_completion_date type="Actual">July 12, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Part A: Open Label Part B: Double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Outcome Measures</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>Percentage of participants with seroconversion of SARS-CoV-2 Spike glycoprotein antigen-specific antibody titers from baseline by binding assays [Immunogenicity]&#xD;
Incidence of adverse events among participants during the study period [Safety and Tolerability]&#xD;
Percentage of Participants with Administration (Injection) Site Reactions [Safety and Tolerability]&#xD;
Incidence of Adverse Events of Special Interest (AESIs) among participants during the study period [Safety and Tolerability]</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Coronavirus Infection</condition>
  <condition>SARS-CoV 2</condition>
  <arm_group>
    <arm_group_label>Group 1 (Part A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Number of Subjects: 20 subjects&#xD;
ID Injection of INO-4800 1mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (Part A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Number of Subjects: 20 subjects&#xD;
ID Injection of INO-4800 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3 (Part B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Number of Subjects: 90 subjects&#xD;
ID Injection of INO-4800 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4 (Part B, Placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Number of Subjects: 30 subjects&#xD;
ID Injection of Placebo (SSC) 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>INO-4800</intervention_name>
    <description>- Manufacturer: Inovio Pharmaceuticals Inc.</description>
    <arm_group_label>Group 1 (Part A)</arm_group_label>
    <arm_group_label>Group 2 (Part A)</arm_group_label>
    <arm_group_label>Group 3 (Part B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CELLECTRA® 2000</intervention_name>
    <description>- Manufacturer: Inovio Pharmaceuticals Inc.</description>
    <arm_group_label>Group 1 (Part A)</arm_group_label>
    <arm_group_label>Group 2 (Part A)</arm_group_label>
    <arm_group_label>Group 3 (Part B)</arm_group_label>
    <arm_group_label>Group 4 (Part B, Placebo)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline-sodium citrate (SSC) buffer</intervention_name>
    <description>- Manufacturer: Inovio Pharmaceuticals Inc.</description>
    <arm_group_label>Group 4 (Part B, Placebo)</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to communicate with investigator, and to provide informed consent and have signed&#xD;
             Informed Consent Form (ICF) prior to screening procedures&#xD;
&#xD;
          -  Adults aged 19 to 50 years (for Part A) or aged 19 to 64 (for Part B)&#xD;
&#xD;
          -  Judged to be healthy by the Investigator on the basis of medical history, physical&#xD;
             examination and vital signs performed at Screening&#xD;
&#xD;
          -  Able and willing to comply with all study procedures&#xD;
&#xD;
          -  Screening laboratory results within normal limits for testing laboratory or deemed not&#xD;
             clinically significant by the Investigator&#xD;
&#xD;
          -  Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C&#xD;
             antibody and Human Immunodeficiency Virus (HIV) antibody or rapid test at screening&#xD;
&#xD;
          -  Screening ECG and Chest X-ray deemed by the Investigator as having no clinically&#xD;
             significant findings (e.g. Wolff-Parkinson-White syndrome);&#xD;
&#xD;
          -  Must meet one of the following criteria with respect to reproductive capacity:&#xD;
&#xD;
             a. Women who are post-menopausal as defined by spontaneous amenorrhea for ≥ 12 months&#xD;
             b. Surgically sterile or have a partner who is sterile (i.e., vasectomy in males or&#xD;
             tubal ligation, absence of ovaries and/or uterus in females). In the case of&#xD;
             vasectomy, subjects should wait six (6) months post-vasectomy prior to enrolling c.&#xD;
             Use of medically effective contraception with a failure rate of &lt; 1% per year when&#xD;
             used consistently and correctly from screening until 3 months following last dose.&#xD;
             Acceptable methods include (but not limited to): c-1. hormonal contraception including&#xD;
             implants, injections or oral c-2. two barrier methods, e.g., condom and cervical cap&#xD;
             (with spermicide) or diaphragm (with spermicide)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding, or intending to become pregnant or father children within&#xD;
             the projected duration of the trial starting with the screening visit until 3 months&#xD;
             following last dose&#xD;
&#xD;
          -  Positive serum pregnancy test during screening or positive urine pregnancy test prior&#xD;
             to dosing&#xD;
&#xD;
          -  Is currently participating in or has participated in a study with an investigational&#xD;
             product within 6 months preceding Day 0&#xD;
&#xD;
          -  Receipt of an investigational product for prophylaxis or treatment of COVID-19, MERS&#xD;
             or SARS&#xD;
&#xD;
          -  Body mass index (BMI) &lt;18 or &gt;30&#xD;
&#xD;
          -  Current or history of the following medical conditions:&#xD;
&#xD;
               1. Respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease);&#xD;
&#xD;
               2. Hypertension, resting systolic blood pressure &gt;150 mm Hg or a diastolic blood&#xD;
                  pressure &gt;95 mm Hg&#xD;
&#xD;
               3. Malignancy within 5 years of screening&#xD;
&#xD;
               4. Cardiovascular diseases (e.g., myocardial infarction, congestive heart failure,&#xD;
                  cardiomyopathy or clinically significant arrhythmias)&#xD;
&#xD;
               5. Diabetes mellitus&#xD;
&#xD;
               6. Use of immunoglobulin or blood products in last 6 months&#xD;
&#xD;
               7. History of severe allergic reaction or anaphylaxis after immunization&#xD;
&#xD;
          -  Immunosuppression as a result of underlying illness or treatment including:&#xD;
&#xD;
               1. Primary immunodeficiencies&#xD;
&#xD;
               2. Long term use (≥7 days) of oral or parenteral glucocorticoids at a dose of ≥20&#xD;
                  mg/day of prednisone equivalent (use of inhaled, topical, nasal, otic, and&#xD;
                  ophthalmic corticosteroids are allowed)&#xD;
&#xD;
               3. Current or anticipated during clinical trial use of disease modifying doses of&#xD;
                  anti-rheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine,&#xD;
                  methotrexate) and biologic disease modifying drugs such as TNF-α inhibitors&#xD;
                  (e.g., infliximab, adalimumab or etanercept)&#xD;
&#xD;
               4. History of solid organ or bone marrow transplantation&#xD;
&#xD;
               5. Any prior history of other clinically significant immunosuppressive or clinically&#xD;
                  diagnosed autoimmune disease that may jeopardize the safety of the subject or&#xD;
                  require therapy that would interfere with study assessments or endpoint&#xD;
                  evaluation, or otherwise impact the validity of the study results.&#xD;
&#xD;
          -  Fewer than two acceptable sites available for ID injection and EP considering the&#xD;
             deltoid and anterolateral quadriceps muscles. The following are unacceptable sites:&#xD;
&#xD;
               1. Tattoos, keloids or hypertrophic scars located within 2 cm of intended&#xD;
                  administration site&#xD;
&#xD;
               2. Implantable-Cardioverter-defibrillator (ICD) or pacemaker (to prevent a&#xD;
                  life-threatening arrhythmia) that is located ipsilateral to the deltoid injection&#xD;
                  site (unless deemed acceptable by a cardiologist)&#xD;
&#xD;
               3. Any metal implants or implantable medical device within the electroporation site&#xD;
&#xD;
          -  Prisoners or subjects who are compulsorily detained (involuntary incarceration)&#xD;
&#xD;
          -  Reported active drug or alcohol or substance abuse or dependence.&#xD;
&#xD;
          -  Current smoker or vaper (use of cigarette or e-cigarette at least once in last 30&#xD;
             days)&#xD;
&#xD;
          -  Healthcare worker who may provide medical care to SARS-CoV-2 cases or occupationally&#xD;
             in high risk for SARS-CoV-2 exposure during the study period&#xD;
&#xD;
          -  Other condition deemed ineligible for the study at the discretion of investigator&#xD;
&#xD;
          -  Employee of the study center directly involved with the proposed study or with study&#xD;
             investigators&#xD;
&#xD;
          -  Previously been laboratory-confirmed as SARS-CoV-2 infection or determined to be a&#xD;
             close-contact of SARS-CoV-2 confirmed case by public health authorities (for Part A&#xD;
             only)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Myoung-don Oh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eu Suk Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>July 14, 2022</last_update_submitted>
  <last_update_submitted_qc>July 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronavirus Infection</keyword>
  <keyword>SARS-CoV 2</keyword>
  <keyword>INO-4800</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Citric Acid</mesh_term>
    <mesh_term>Sodium Citrate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data dictionaries and all collected IPD will be anonymized and may be made available upon reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 3 years following the end of the study.</ipd_time_frame>
    <ipd_access_criteria>Those who request the anonymous IPD must provide a plan of study explaining how the data will be used. Requests may be sent to the Central Contact Person. Requests will be reviewed based on the potential for the planned use of the IPD for advancing scientific knowledge and theory.</ipd_access_criteria>
  </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/NCT04447781
org study id: IVI COVID19-001
nct id: NCT04447781
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: Yes
This is a phase I/IIa trial to evaluate the safety, tolerability and immunological profile of
      INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using
      the CELLECTRA® 2000 device in healthy adults aged 19 to 64 years in Republic of Korea. INO-
      4800 contains the plasmid pGX9501, which encodes for the full length of the Spike
      glycoprotein of SARS-CoV-2. The primary objective of this trial is to evaluate the
      tolerability, safety, and immunogenicity of INO-4800 administered by ID injection followed by
      EP in healthy adults in the Part A and Part B. Enrollment into Part A, and Part B will
      proceed sequentially.
[Part A] Part A is open-label, dose-ranging study, enrolling total of 40 subjects. Part A is
      divided into two arm, low dose (Group 1) and high dose (Group 2). The subjects will be
      contacted by telephone to report adverse events or other reactions the day following the
      first vaccination. Once these first five subjects in Group 1 complete the Week 1 visit, all
      available clinical laboratory and adverse event data will be reviewed by the Data Safety
      Monitoring Board (DSMB). Further enrollment into Group 1 will be paused during this DSMB
      review. If DSMB determines there are no safety findings judged to be of clinical concern and
      no dose limiting toxicities nor any stopping events observed, enrollment will be opened for
      the remaining subjects in Group 1. Once Group 1 enrollment is completed [i.e., 20 total
      subjects enrolled], Group 2 will open to enrollment. Daily safety assessment of all enrolled
      subjects will be supported by the Study Medical Monitor on an ongoing basis while the first
      five subjects are being enrolled, if needed. The subjects will be contacted by telephone to
      report adverse events or other reactions the day following the first vaccination. Once the
      first five subjects Group 2 complete the Week 1 visit, all available clinical laboratory and
      adverse event data from these first five subjects, along with the safety data from subjects
      in Group 1, will be reviewed by the DSMB. However, enrollment may continue while this DSMB
      review is conducted, without any pause to enrollment of the remaining subjects in Group 2.

      Once all subjects in Part A Group 1 and Group 2 complete the Week 8 visit, all available
      clinical laboratory, adverse event, immunogenicity data from all subjects will be reviewed by
      the DSMB. The DSMB will additionally review serious adverse events (SAEs) and adverse events
      of special interest (AESIs) date throughout the study. With DSMB's recommendation, the
      optimal dose for Part B will be selected by the Sponsor based on the following criteria which
      may be adjusted over the course of the study. Percentage immunogenic seroconversionRelative
      immunogenicity between INO-4800 Study Arms (Low dose vs. High dose)Safety profile of each
      INO-4800 Study Arms (Low dose vs. High dose). All subjects will be followed for 48 weeks
      following the 2nd vaccination. Week 52 will be the End of Study (EOS) visit.

      [Part B] Part B is divided into two arm, IP Arm (Group 3) and Placebo Arm (Group 4). Part B
      will be randomized, double-blind, placebo-controlled trial, enrolling 60 subjects in IP arm,
      and 20 subjects in Placebo arm in 19-50 age group, and 30 subjects in IP arm, and 10 subjects
      in Placebo arm in 51-64 age group, for total of 90 subjects in IP arm, and 30 subjects in
      Placebo arm. At dosing visit, subjects will be randomized to either Group 3 or Group 4. The
      subjects will be contacted by telephone to report adverse events or other reactions the day
      following the first vaccination. DSMB review of safety findings will be performed according
      to the DSMB charter. All subjects will be followed for 48 weeks following the 2nd
      vaccination. Week 52 will be the End of Study (EOS) visit.Should the criteria for any dose
      limiting toxicity or stopping rule be met, at any time, further enrollment and administration
      of INO-4800 will be paused for further evaluation. The Sponsor will consult the DSMB, if
      needed, to determine whether to enroll and/or dose the remainder of the subjects. All
      subjects will be followed for 48 weeks following the 2nd vaccination. Week 52 will be the End
      of Study (EOS) visit.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Part A: Open Label Part B: Double-blind
measure: Primary Outcome Measures
time frame: Baseline up to Week 52
description: Percentage of participants with seroconversion of SARS-CoV-2 Spike glycoprotein antigen-specific antibody titers from baseline by binding assays [Immunogenicity]
Incidence of adverse events among participants during the study period [Safety and Tolerability]
Percentage of Participants with Administration (Injection) Site Reactions [Safety and Tolerability]
Incidence of Adverse Events of Special Interest (AESIs) among participants during the study period [Safety and Tolerability]
arm group label: Group 1 (Part A)
arm group type: Experimental
description: Number of Subjects: 20 subjects
ID Injection of INO-4800 1mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
arm group label: Group 2 (Part A)
arm group type: Experimental
description: Number of Subjects: 20 subjects
ID Injection of INO-4800 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
arm group label: Group 3 (Part B)
arm group type: Experimental
description: Number of Subjects: 90 subjects
ID Injection of INO-4800 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
arm group label: Group 4 (Part B, Placebo)
arm group type: Placebo Comparator
description: Number of Subjects: 30 subjects
ID Injection of Placebo (SSC) 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
intervention type: Biological
intervention name: INO-4800
description: - Manufacturer: Inovio Pharmaceuticals Inc.
arm group label: Group 1 (Part A)
arm group label: Group 2 (Part A)
arm group label: Group 3 (Part B)
intervention type: Device
intervention name: CELLECTRA® 2000
description: - Manufacturer: Inovio Pharmaceuticals Inc.
arm group label: Group 1 (Part A)
arm group label: Group 2 (Part A)
arm group label: Group 3 (Part B)
arm group label: Group 4 (Part B, Placebo)
intervention type: Other
intervention name: Saline-sodium citrate (SSC) buffer
description: - Manufacturer: Inovio Pharmaceuticals Inc.
arm group label: Group 4 (Part B, Placebo)
other name: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Myoung-don Oh, MD
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: Eu Suk Kim, MD
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Coronavirus Infections
mesh term: Citric Acid
mesh term: Sodium Citrate
sharing ipd: Yes
ipd description: Data dictionaries and all collected IPD will be anonymized and may be made available upon reasonable request.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 3 years following the end of the study.
ipd access criteria: Those who request the anonymous IPD must provide a plan of study explaining how the data will be used. Requests may be sent to the Central Contact Person. Requests will be reviewed based on the potential for the planned use of the IPD for advancing scientific knowledge and theory.