<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/NCT03805984</url>
  </required_header>
  <id_info>
    <org_study_id>LSV-001</org_study_id>
    <nct_id>NCT03805984</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers</brief_title>
  <official_title>Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inovio Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Coalition for Epidemic Preparedness Innovations</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Inovio Pharmaceuticals</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized and double-blinded within study group, placebo-controlled trial to&#xD;
      evaluate the safety, tolerability and immunological profile of INO-4500 administered by&#xD;
      intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in&#xD;
      healthy adult volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 9, 2019</start_date>
  <completion_date type="Actual">October 21, 2020</completion_date>
  <primary_completion_date type="Actual">October 21, 2020</primary_completion_date>
  <phase>Phase 1</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, Care Provider, Investigator)</masking>
    <masking_description>The Sponsor will be blinded up to Week 6; at that time the Sponsor will become group-level unblinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants with Adverse Events (AEs)</measure>
    <time_frame>Baseline up to Week 48</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants with Injection Site Reactions</measure>
    <time_frame>Day 0 up to Week 48</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of adverse events of special interest</measure>
    <time_frame>Baseline up to Week 48</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Antigen Specific Binding Antibody titers</measure>
    <time_frame>Day 0 up to Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies</measure>
    <time_frame>Day 0 up to Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Interferon-Gamma Response Magnitude</measure>
    <time_frame>Day 0 up to Week 48</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Lassa Fever</condition>
  <arm_group>
    <arm_group_label>INO-4500 Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Comparator Group A</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>INO-4500 Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Comparator Group B</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INO-4500</intervention_name>
    <description>INO-4500 will be administered ID on Day 0 and Week 4.</description>
    <arm_group_label>INO-4500 Group A</arm_group_label>
    <arm_group_label>INO-4500 Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be administered ID on Day 0 and Week 4.</description>
    <arm_group_label>Placebo Comparator Group A</arm_group_label>
    <arm_group_label>Placebo Comparator Group B</arm_group_label>
    <other_name>SSC-0001</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CELLECTRA® 2000</intervention_name>
    <description>EP using the CELLECTRA® 2000 device will be administered following ID drug administration.</description>
    <arm_group_label>INO-4500 Group A</arm_group_label>
    <arm_group_label>INO-4500 Group B</arm_group_label>
    <arm_group_label>Placebo Comparator Group A</arm_group_label>
    <arm_group_label>Placebo Comparator Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#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;
          -  Negative tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human&#xD;
             Immunodeficiency Virus (HIV) antibody;&#xD;
&#xD;
          -  Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically&#xD;
             significant findings (e.g. Wolff-Parkinson-White syndrome);&#xD;
&#xD;
          -  Use of medically effective contraception with a failure rate of &lt; 1% per year when&#xD;
             used consistently and correctly from screening until 6 months following last dose or&#xD;
             be post-menopausal or be surgically sterile or have a partner who is sterile.&#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 1 month&#xD;
             following last dose;&#xD;
&#xD;
          -  Is currently participating in or has participated in a study with an investigational&#xD;
             product within 30 days preceding Day 0;&#xD;
&#xD;
          -  Previous receipt of an investigational vaccine product for prevention of Lassa Fever;&#xD;
&#xD;
          -  Fewer than two acceptable sites available for ID injection and EP considering the&#xD;
             deltoid and anterolateral quadriceps muscles;&#xD;
&#xD;
          -  Audiometry testing that demonstrates a hearing level threshold of 30 dB or greater for&#xD;
             any frequency tested between 250 Hz - 8000 Hz;&#xD;
&#xD;
          -  Recent (within 6 months) or planned travel to Lassa-endemic region;&#xD;
&#xD;
          -  Current or anticipated concomitant immunosuppressive therapy.&#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>Mammen Mammen, MD, FACP, FIDSA</last_name>
    <role>Study Director</role>
    <affiliation>Inovio Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Center for Pharmaceutical Research</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>November 20, 2020</last_update_submitted>
  <last_update_submitted_qc>November 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy volunteer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lassa Fever</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon 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 10 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/NCT03805984
org study id: LSV-001
nct id: NCT03805984
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
This is a randomized and double-blinded within study group, placebo-controlled trial to
      evaluate the safety, tolerability and immunological profile of INO-4500 administered by
      intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in
      healthy adult volunteers.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
masking description: The Sponsor will be blinded up to Week 6; at that time the Sponsor will become group-level unblinded.
measure: Percentage of Participants with Adverse Events (AEs)
time frame: Baseline up to Week 48
measure: Percentage of Participants with Injection Site Reactions
time frame: Day 0 up to Week 48
measure: Incidence of adverse events of special interest
time frame: Baseline up to Week 48
measure: Change from Baseline in Antigen Specific Binding Antibody titers
time frame: Day 0 up to Week 48
measure: Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies
time frame: Day 0 up to Week 48
measure: Change from Baseline in Interferon-Gamma Response Magnitude
time frame: Day 0 up to Week 48
arm group label: INO-4500 Group A
arm group type: Experimental
description: Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
arm group label: Placebo Comparator Group A
arm group type: Placebo Comparator
description: Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
arm group label: INO-4500 Group B
arm group type: Experimental
description: Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
arm group label: Placebo Comparator Group B
arm group type: Placebo Comparator
description: Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
intervention type: Drug
intervention name: INO-4500
description: INO-4500 will be administered ID on Day 0 and Week 4.
arm group label: INO-4500 Group A
arm group label: INO-4500 Group B
intervention type: Drug
intervention name: Placebo
description: Placebo will be administered ID on Day 0 and Week 4.
arm group label: Placebo Comparator Group A
arm group label: Placebo Comparator Group B
other name: SSC-0001
intervention type: Device
intervention name: CELLECTRA® 2000
description: EP using the CELLECTRA® 2000 device will be administered following ID drug administration.
arm group label: INO-4500 Group A
arm group label: INO-4500 Group B
arm group label: Placebo Comparator Group A
arm group label: Placebo Comparator Group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mammen Mammen, MD, FACP, FIDSA
role: Study Director
affiliation: Inovio Pharmaceuticals
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lassa Fever
sharing ipd: Yes
ipd description: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon 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 10 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.