<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/NCT03831503</url>
  </required_header>
  <id_info>
    <org_study_id>832135</org_study_id>
    <nct_id>NCT03831503</nct_id>
  </id_info>
  <brief_title>A Study of INO-A002 in Healthy Dengue Virus-naive Adults</brief_title>
  <official_title>A Phase 1 Study of INO-A002 in Healthy Dengue Virus-naive Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Inovio Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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>
      Phase 1, open label, single center, dose escalation study to evaluate the safety,&#xD;
      tolerability and pharmacokinetic profile of dMAb-ZK190 following delivery of INO-A002 with&#xD;
      Hylenex® recombinant delivered IM followed by EP in healthy adult Dengue naïve volunteers&#xD;
      ages 18-60 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1, open label, single center, dose escalation study to evaluate the safety,&#xD;
      tolerability and pharmacokinetic profile of dMAb-ZK190 following delivery of INO-A002 with&#xD;
      Hylenex® recombinant delivered IM followed by EP in healthy adult Dengue naïve volunteers&#xD;
      ages 18-60 years.&#xD;
&#xD;
      The study will apply a 3+3 design such that 3 additional subjects will be enrolled into the&#xD;
      cohort if one DLT (Section 7.3.1) is observed in one out of the first 3 subjects dosed during&#xD;
      the 28-day period of safety and PK assessment. If no additional DLT is observed in 3&#xD;
      additional subjects (i.e., 1 DLT in 6 total subjects), dosing will proceed to the subsequent&#xD;
      cohort. However, if any additional DLT occurs (i.e., &gt;1 DLT in 6 total subjects), then that&#xD;
      dose will be deemed not tolerated and the prior dose will be considered the maximum tolerated&#xD;
      dose (MTD).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">October 3, 2022</completion_date>
  <primary_completion_date type="Actual">October 3, 2022</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>This study will adhere to a dose escalation scheme. There are five cohorts for Study ZIKA-dMAb 01. Participants (n=6 per cohort) will be administered INO-A002 at four dose levels: 0.5, 1, 2, and 4 mg DNA/dose.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the safety of escalating doses of INO-A002 with Hylenex® administered IM followed by electroporation with the CELLECTRA® 2000 device in healthy adult volunteers.</measure>
    <time_frame>52 weeks</time_frame>
    <description>Safety will be assessed by monitoring the frequency and severity of adverse events utilizing the &quot;Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials&quot; with labs assessed as per site normal values.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the tolerability of escalating doses of INO-A002 with Hylenex® administered IM followed by electroporation with the CELLECTRA® 2000 device in healthy adult volunteers.</measure>
    <time_frame>10 minutes</time_frame>
    <description>Pain will be assessed by administration (i.e., injection) site reactions (frequency and severity) and visual analogue scale (VAS) scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine the maximum serum concentration (Cmax) of the monoclonal antibody dMAb-ZK190 in the serum upon administration of INO-A002 with Hylenex® delivered IM followed by electroporation.</measure>
    <time_frame>52 weeks</time_frame>
    <description>The maximum serum concentration (Cmax) assessment will be performed by the analysis of dMAb-ZK190 levels at baseline; days 1, 3, 7 and at weeks 2, 3, 4, 5, 6, 8, 12, 16, 24 and 52. Serum concentration in micrograms/mL will be used as the measurement scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine the minimum serum concentration (Cmin) of the monoclonal antibody dMAb-ZK190 in the serum upon administration of INO-A002 with Hylenex® delivered IM followed by electroporation.</measure>
    <time_frame>52 weeks</time_frame>
    <description>The minimum serum concentration (Cmin) assessment will be performed by the analysis of dMAb-ZK190 levels at baseline; days 1, 3, 7 and at weeks 2, 3, 4, 5, 6, 8, 12, 16, 24 and 52. Serum concentration in micrograms/mL will be used as the measurement scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine the Area Under the Curve (AUC0-t) of the monoclonal antibody dMAb-ZK190 in the serum upon administration of INO-A002 with Hylenex® delivered IM followed by electroporation</measure>
    <time_frame>52 weeks</time_frame>
    <description>The Area Under the Curve (AUC0-t) will be performed by the analysis of dMAb-ZK190 levels at baseline; days 1, 3, 7 and at weeks 2, 3, 4, 5, 6, 8, 12, 16, 24 and 52. The Area Under the Curve (AUC0-t) against time will be calculated using the trapezoidal method.</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Cohort A - 0.5mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants (n=6 per cohort) will be administered 1 injection (Day 0) of INO-A002 at 0.5 mg DNA/dose. Inoculation will be administered as 0.5 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B - 1mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants (n=6 per cohort) will be administered 1 injection (Day 0) of INO-A002 at 1 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort C - 2mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 2 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort D - 4mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 4 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort E - 4mg Side Port</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 4 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device with Side Port needle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>INO-A002</intervention_name>
    <description>Participants will receive one or two 1 ml IM injections (in different arms) into the deltoid region at day 0 (all groups), and in addition on day 3 (in the 2 mg and 4 mg cohorts).</description>
    <arm_group_label>Cohort A - 0.5mg</arm_group_label>
    <arm_group_label>Cohort B - 1mg</arm_group_label>
    <arm_group_label>Cohort C - 2mg</arm_group_label>
    <arm_group_label>Cohort D - 4mg</arm_group_label>
    <arm_group_label>Cohort E - 4mg Side Port</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CELLECTRA® 2000</intervention_name>
    <description>Inoculation will be followed by electroporation with the CELLECTRA® 2000 device.</description>
    <arm_group_label>Cohort A - 0.5mg</arm_group_label>
    <arm_group_label>Cohort B - 1mg</arm_group_label>
    <arm_group_label>Cohort C - 2mg</arm_group_label>
    <arm_group_label>Cohort D - 4mg</arm_group_label>
    <arm_group_label>Cohort E - 4mg Side Port</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dengue Fever Antibodies (IgG)</intervention_name>
    <description>To determine if the subject is Dengue seronegative at baseline</description>
    <arm_group_label>Cohort A - 0.5mg</arm_group_label>
    <arm_group_label>Cohort B - 1mg</arm_group_label>
    <arm_group_label>Cohort C - 2mg</arm_group_label>
    <arm_group_label>Cohort D - 4mg</arm_group_label>
    <arm_group_label>Cohort E - 4mg Side Port</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Age 18-60 years;&#xD;
&#xD;
          2. Able to provide consent to participate and having signed an Informed Consent Form&#xD;
             (ICF);&#xD;
&#xD;
          3. Able and willing to comply with all study procedures;&#xD;
&#xD;
          4. Body mass index (BMI) between 20 and 30, inclusive&#xD;
&#xD;
          5. Screening laboratory must be within normal limits or have only Grade 0-1 findings;&#xD;
&#xD;
          6. Normal screening ECG or screening ECG with no clinically significant findings;&#xD;
&#xD;
          7. Women of child-bearing potential agree to use medically effective contraception (oral&#xD;
             contraception, barrier methods, spermicide with barrier methods, etc.) or have a&#xD;
             partner who is sterile from enrollment to 6 months following the last injection, or&#xD;
             have a partner who is medically unable to induce pregnancy.&#xD;
&#xD;
          8. Sexually active men who are considered sexually fertile must agree to use either a&#xD;
             barrier method of contraception during the study, and agree to continue the use for at&#xD;
             least 6 months following the last injection, or have a partner who is permanently&#xD;
             sterile or is medically unable to become pregnant;&#xD;
&#xD;
          9. No history of clinically significant immunosuppressive or autoimmune disease.&#xD;
             Individuals with HIV infection who have been virologically suppressed for more than 1&#xD;
             year and with current CD4 cell count entry greater than 500 cells/ul will be allowed&#xD;
             into the study.&#xD;
&#xD;
         10. No history of dengue virus vaccination or illness; no history of yellow fever&#xD;
             vaccination.&#xD;
&#xD;
         11. Dengue seronegative at baseline by screening laboratory evaluation&#xD;
&#xD;
         12. Not currently or within the previous 4 weeks taking immunosuppressive agents&#xD;
             (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose&#xD;
             methotrexate, or prednisone at a dose less than 10 mg/day or steroid dose-equivalent).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Administration of an investigational compound either currently or within 30 days of&#xD;
             first dose;&#xD;
&#xD;
          2. Previous receipt of an investigational product for the treatment or prevention of Zika&#xD;
             virus except if participant is verified to have received placebo;&#xD;
&#xD;
          3. Administration of any vaccine within 4 weeks of first dose;&#xD;
&#xD;
          4. Administration of any monoclonal or polyclonal antibody product within 4 weeks of the&#xD;
             first dose&#xD;
&#xD;
          5. Administration of any blood product within 3 months of first dose;&#xD;
&#xD;
          6. Pregnancy or breast feeding or plans to become pregnant during the course of the&#xD;
             study;&#xD;
&#xD;
          7. Positive serologic result for dengue virus (any serotype) or history of receipt of&#xD;
             either dengue virus or yellow fever virus vaccination at any time in the past;&#xD;
&#xD;
          8. Positive serologic test for hepatitis B surface antigen (HBsAg); or any potentially&#xD;
             communicable infectious disease as determined by the Principal Investigator or Medical&#xD;
             Monitor;&#xD;
&#xD;
          9. Positive serologic test for hepatitis C (exception: successful treatment with&#xD;
             confirmation of sustained virologic response);&#xD;
&#xD;
         10. Baseline evidence of kidney disease as measured by creatinine greater than 1.5 (CKD&#xD;
             Stage II or greater);&#xD;
&#xD;
         11. Baseline screening lab(s) with Grade 2 or higher abnormality, except for Grade 2&#xD;
             creatinine;&#xD;
&#xD;
         12. Chronic liver disease or cirrhosis;&#xD;
&#xD;
         13. Immunosuppressive illness including hematologic malignancy, history of solid organ or&#xD;
             bone marrow transplantation;&#xD;
&#xD;
         14. Current or anticipated concomitant immunosuppressive therapy (excluding inhaled,&#xD;
             topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or&#xD;
             prednisone at a dose greater than 10 mg/day or steroid dose-equivalent);&#xD;
&#xD;
         15. Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab,&#xD;
             etanercept;&#xD;
&#xD;
         16. Prior major surgery or any radiation therapy within 4 weeks of group assignment;&#xD;
&#xD;
         17. Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;&#xD;
&#xD;
         18. Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator&#xD;
             (AICD)&#xD;
&#xD;
         19. Fewer than two acceptable sites available for IM injection and EP considering the&#xD;
             deltoid and anterolateral quadriceps muscles. The following are unacceptable sites:&#xD;
&#xD;
               -  Tattoos, keloids or hypertrophic scars located within 2 cm of intended&#xD;
                  administration site;&#xD;
&#xD;
               -  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;
               -  Any metal implants or implantable medical device within the electroporation site.&#xD;
&#xD;
         20. Prisoner or participants who are compulsorily detained (involuntary incarceration) for&#xD;
             treatment of either a physical or psychiatric illness;&#xD;
&#xD;
         21. Active drug or alcohol use or dependence that, in the opinion of the investigator,&#xD;
             would interfere with adherence to study requirements or assessment of immunologic&#xD;
             endpoints; or&#xD;
&#xD;
         22. Not willing to allow storage and future use of samples for Zika virus related research&#xD;
&#xD;
         23. Any illness or condition that in the opinion of the investigator may affect the safety&#xD;
             of the participant or the evaluation of any study endpoint.&#xD;
&#xD;
         24. Participants who plan to travel within 6 months of INO-A002 administration to a&#xD;
             geographic location where DENV or ZIKV are currently active.&#xD;
&#xD;
         25. Participants with known bleeding diatheses or that are using blood thinners for 30&#xD;
             days before study enrollment including warfarin, heparin, Clopidogrel, Apixaban&#xD;
             (Eliquis), Dabigatran (Pradaxa), Edoxaban (Savaysa), Rivaroxaban (Xarelto). The use of&#xD;
             low dose aspirin (81 mg daily) will be acceptable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pablo Tebas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 17, 2023</last_update_submitted>
  <last_update_submitted_qc>February 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dengue</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03831503
org study id: 832135
nct id: NCT03831503
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
Phase 1, open label, single center, dose escalation study to evaluate the safety,
      tolerability and pharmacokinetic profile of dMAb-ZK190 following delivery of INO-A002 with
      Hylenex® recombinant delivered IM followed by EP in healthy adult Dengue naïve volunteers
      ages 18-60 years.
This is a Phase 1, open label, single center, dose escalation study to evaluate the safety,
      tolerability and pharmacokinetic profile of dMAb-ZK190 following delivery of INO-A002 with
      Hylenex® recombinant delivered IM followed by EP in healthy adult Dengue naïve volunteers
      ages 18-60 years.

      The study will apply a 3+3 design such that 3 additional subjects will be enrolled into the
      cohort if one DLT (Section 7.3.1) is observed in one out of the first 3 subjects dosed during
      the 28-day period of safety and PK assessment. If no additional DLT is observed in 3
      additional subjects (i.e., 1 DLT in 6 total subjects), dosing will proceed to the subsequent
      cohort. However, if any additional DLT occurs (i.e., >1 DLT in 6 total subjects), then that
      dose will be deemed not tolerated and the prior dose will be considered the maximum tolerated
      dose (MTD).
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: This study will adhere to a dose escalation scheme. There are five cohorts for Study ZIKA-dMAb 01. Participants (n=6 per cohort) will be administered INO-A002 at four dose levels: 0.5, 1, 2, and 4 mg DNA/dose.
primary purpose: Prevention
masking: None (Open Label)
measure: Evaluate the safety of escalating doses of INO-A002 with Hylenex® administered IM followed by electroporation with the CELLECTRA® 2000 device in healthy adult volunteers.
time frame: 52 weeks
description: Safety will be assessed by monitoring the frequency and severity of adverse events utilizing the "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" with labs assessed as per site normal values.
measure: Evaluate the tolerability of escalating doses of INO-A002 with Hylenex® administered IM followed by electroporation with the CELLECTRA® 2000 device in healthy adult volunteers.
time frame: 10 minutes
description: Pain will be assessed by administration (i.e., injection) site reactions (frequency and severity) and visual analogue scale (VAS) scores.
measure: Determine the maximum serum concentration (Cmax) of the monoclonal antibody dMAb-ZK190 in the serum upon administration of INO-A002 with Hylenex® delivered IM followed by electroporation.
time frame: 52 weeks
description: The maximum serum concentration (Cmax) assessment will be performed by the analysis of dMAb-ZK190 levels at baseline; days 1, 3, 7 and at weeks 2, 3, 4, 5, 6, 8, 12, 16, 24 and 52. Serum concentration in micrograms/mL will be used as the measurement scale.
measure: Determine the minimum serum concentration (Cmin) of the monoclonal antibody dMAb-ZK190 in the serum upon administration of INO-A002 with Hylenex® delivered IM followed by electroporation.
time frame: 52 weeks
description: The minimum serum concentration (Cmin) assessment will be performed by the analysis of dMAb-ZK190 levels at baseline; days 1, 3, 7 and at weeks 2, 3, 4, 5, 6, 8, 12, 16, 24 and 52. Serum concentration in micrograms/mL will be used as the measurement scale.
measure: Determine the Area Under the Curve (AUC0-t) of the monoclonal antibody dMAb-ZK190 in the serum upon administration of INO-A002 with Hylenex® delivered IM followed by electroporation
time frame: 52 weeks
description: The Area Under the Curve (AUC0-t) will be performed by the analysis of dMAb-ZK190 levels at baseline; days 1, 3, 7 and at weeks 2, 3, 4, 5, 6, 8, 12, 16, 24 and 52. The Area Under the Curve (AUC0-t) against time will be calculated using the trapezoidal method.
arm group label: Cohort A - 0.5mg
arm group type: Experimental
description: Participants (n=6 per cohort) will be administered 1 injection (Day 0) of INO-A002 at 0.5 mg DNA/dose. Inoculation will be administered as 0.5 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.
arm group label: Cohort B - 1mg
arm group type: Experimental
description: Participants (n=6 per cohort) will be administered 1 injection (Day 0) of INO-A002 at 1 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.
arm group label: Cohort C - 2mg
arm group type: Experimental
description: Participants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 2 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.
arm group label: Cohort D - 4mg
arm group type: Experimental
description: Participants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 4 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.
arm group label: Cohort E - 4mg Side Port
arm group type: Experimental
description: Participants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 4 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device with Side Port needle.
intervention type: Biological
intervention name: INO-A002
description: Participants will receive one or two 1 ml IM injections (in different arms) into the deltoid region at day 0 (all groups), and in addition on day 3 (in the 2 mg and 4 mg cohorts).
arm group label: Cohort A - 0.5mg
arm group label: Cohort B - 1mg
arm group label: Cohort C - 2mg
arm group label: Cohort D - 4mg
arm group label: Cohort E - 4mg Side Port
intervention type: Device
intervention name: CELLECTRA® 2000
description: Inoculation will be followed by electroporation with the CELLECTRA® 2000 device.
arm group label: Cohort A - 0.5mg
arm group label: Cohort B - 1mg
arm group label: Cohort C - 2mg
arm group label: Cohort D - 4mg
arm group label: Cohort E - 4mg Side Port
intervention type: Device
intervention name: Dengue Fever Antibodies (IgG)
description: To determine if the subject is Dengue seronegative at baseline
arm group label: Cohort A - 0.5mg
arm group label: Cohort B - 1mg
arm group label: Cohort C - 2mg
arm group label: Cohort D - 4mg
arm group label: Cohort E - 4mg Side Port
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pablo Tebas, MD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dengue
mesh term: Antibodies