<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/NCT02988739</url>
  </required_header>
  <id_info>
    <org_study_id>PCT-007</org_study_id>
    <nct_id>NCT02988739</nct_id>
  </id_info>
  <brief_title>Comparison of Laser Assisted Epidermal to Intradermal Administration of Seasonal Influenza Vaccine</brief_title>
  <official_title>Safety and Immunogenicity of Laser Assisted Epidermally Administered Seasonal Influenza Vaccine in Comparison to Intradermally Administered Seasonal Influenza Vaccine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pantec Biosolutions AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pantec Biosolutions AG</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>
      It is the aim of the present study to compare the immunogenicity induced by a laser-assisted&#xD;
      epidermally administered seasonal influenza vaccine to an intradermally administered seasonal&#xD;
      influenza vaccine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The skin is an attractive tissue for vaccination due to the impact of the cutaneous&#xD;
      micro-environment on the adaptive and non-adaptive immune responses. Conventionally many&#xD;
      vaccines are administered subcutaneously. Immune-competent cells however are not resident in&#xD;
      the subcutaneous fat tissue, but instead are located in the epidermis and the dermis of the&#xD;
      skin. Depending on the targeted skin layer and administration method, different immunological&#xD;
      outcomes are thus anticipated following vaccination.&#xD;
&#xD;
      In the present study, the immunogenicity (in terms of activation of B-cell mediated and&#xD;
      T-cell mediated immune responses) of laser-assisted epidermally administered seasonal&#xD;
      influenza vaccine will be compared to needle-based intradermal administration of the same&#xD;
      seasonal influenza vaccine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2017</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Haemagglutination inhibition (HAI)</measure>
    <time_frame>day 1 and day 29</time_frame>
    <description>HAI against each vaccine virus strain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of vaccine specific T-cell responders</measure>
    <time_frame>day 1, day 15 and day 29</time_frame>
    <description>Number of subjects achieving a T-cell stimulation index of &gt;3</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seroconversion rate</measure>
    <time_frame>day 1 and day 29</time_frame>
    <description>Proportion of subjects achieving at least a four fold HAI titer increase against each vaccine virus strain from day 1 to day 29</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroprotection rate</measure>
    <time_frame>day 1 and day 29</time_frame>
    <description>Proportion of subjects achieving a HAI titer of &gt; 1:40 against each vaccine virus strain at day 29</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean fold rise (GMFR) of antibody titers</measure>
    <time_frame>day 1 and day 29</time_frame>
    <description>GMFR of antibody titers against each vaccine virus strain from day 1 to day 29.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnitude of T-cell response</measure>
    <time_frame>day 1 , day 15 and day 29</time_frame>
    <description>Magnitude of T-cell response (SI values) against influenza vaccine on day 1, day 15 and day 29.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and severity of local and systemic adverse events following vaccination</measure>
    <time_frame>day 1 to day 29</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Influenza in Human</condition>
  <arm_group>
    <arm_group_label>Laser assisted epidermal application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laser pretreatment: 4 adjacent areas of 2 cm² each (14mm x 14 mm) will be pretreated with an Erbium Yttrium Aluminium Garnet laser (22,7 J/cm², 2 pulses, Density: 5%) generating micropores with a depth of approximately 91 µm.&#xD;
0,1 ml of Intanza (15 µg, seasonal trivalent influenza vaccine) will be topically administered on the laser-treated area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intradermal application</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0,1 ml of Intanza (15 µg, seasonal trivalent influenza vaccine) will be intradermally injected in the deltoid area.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>seasonal influenza vaccine</intervention_name>
    <description>influenza vaccine containing 15 µg haemagglutinin of three seasonal influenza virus strains recommended by WHO</description>
    <arm_group_label>Intradermal application</arm_group_label>
    <arm_group_label>Laser assisted epidermal application</arm_group_label>
    <other_name>INTANZA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>fractional Er:Yag laser</intervention_name>
    <description>Fraction laser device to apply micorpores of defined depth and density into skin.</description>
    <arm_group_label>Laser assisted epidermal application</arm_group_label>
    <other_name>Pantec P.L.E.A.S.E.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  18-30 years old (male or female),&#xD;
&#xD;
          -  Photo type I to IV (according to Fitzpatrick scale),&#xD;
&#xD;
          -  Subject must be willing and able to comply with study protocol for the duration of the&#xD;
             study,&#xD;
&#xD;
          -  Females of childbearing potential (FCB) must maintain reliable contraception&#xD;
             throughout the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known pregnancy or positive pregnancy test for women of child bearing potential,&#xD;
&#xD;
          -  Positive screening assessment for human immunodeficiency virus or viral hepatitis&#xD;
             (Hepatitis B or Hepatitis C)&#xD;
&#xD;
          -  Known or suspected immune dysfunction that is caused by a medical condition, or any&#xD;
             other cause and that would interfere with the conduct of the study,&#xD;
&#xD;
          -  Use, within the past 3 months, of any topical or systemic treatment that would&#xD;
             interfere with assessment and/or investigational treatment (anti-inflammatory drugs,&#xD;
             immune suppressors or any immune modulator agent),&#xD;
&#xD;
          -  Use of any topical treatment on the injection site within the last four weeks,&#xD;
&#xD;
          -  Photo type V and VI (according to Fitzpatrick scale),&#xD;
&#xD;
          -  Skin lesions or excessive hair growth at treatment site,&#xD;
&#xD;
          -  Any history of seasonal influenza in the past 6 months,&#xD;
&#xD;
          -  Any seasonal influenza vaccine in the past,&#xD;
&#xD;
          -  Preexisting HAI antibody titers of &gt;40 against more than one influenza strain included&#xD;
             in the vaccine,&#xD;
&#xD;
          -  Acute illness or febrile illness (over 37,5°C) within one week prior to enrollment,&#xD;
&#xD;
          -  Hypersensitivity to elements of the influenza vaccine (e.g. egg),&#xD;
&#xD;
          -  Administration of any live vaccine (&lt; 28 days) or inactivated/toxoid vaccine (&lt; 14&#xD;
             days) or planned vaccination within 3 months after inclusion,&#xD;
&#xD;
          -  Medical history of skin cancer,&#xD;
&#xD;
          -  History of Guillain Barre syndrome or brachial neuritis following previous&#xD;
             vaccination,&#xD;
&#xD;
          -  Any history of having blood transfusions or administration with gamma globulin in the&#xD;
             past 3 months&#xD;
&#xD;
          -  Women of childbearing potential not actively practicing birth control or using&#xD;
             medically accepted device or therapy,&#xD;
&#xD;
          -  Subject being judged as inadequate for following the procedures of the trial by&#xD;
             investigator,&#xD;
&#xD;
          -  Participation in another clinical trial (including follow up phase of a previous&#xD;
             clinical trial)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University Vienna, University Clinic for Clinical Pharmacology</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2018</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>Influenza, Human</mesh_term>
  </condition_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/NCT02988739
org study id: PCT-007
nct id: NCT02988739
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is the aim of the present study to compare the immunogenicity induced by a laser-assisted
      epidermally administered seasonal influenza vaccine to an intradermally administered seasonal
      influenza vaccine.
The skin is an attractive tissue for vaccination due to the impact of the cutaneous
      micro-environment on the adaptive and non-adaptive immune responses. Conventionally many
      vaccines are administered subcutaneously. Immune-competent cells however are not resident in
      the subcutaneous fat tissue, but instead are located in the epidermis and the dermis of the
      skin. Depending on the targeted skin layer and administration method, different immunological
      outcomes are thus anticipated following vaccination.

      In the present study, the immunogenicity (in terms of activation of B-cell mediated and
      T-cell mediated immune responses) of laser-assisted epidermally administered seasonal
      influenza vaccine will be compared to needle-based intradermal administration of the same
      seasonal influenza vaccine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Haemagglutination inhibition (HAI)
time frame: day 1 and day 29
description: HAI against each vaccine virus strain
measure: Frequency of vaccine specific T-cell responders
time frame: day 1, day 15 and day 29
description: Number of subjects achieving a T-cell stimulation index of >3
measure: Seroconversion rate
time frame: day 1 and day 29
description: Proportion of subjects achieving at least a four fold HAI titer increase against each vaccine virus strain from day 1 to day 29
measure: Seroprotection rate
time frame: day 1 and day 29
description: Proportion of subjects achieving a HAI titer of > 1:40 against each vaccine virus strain at day 29
measure: Geometric Mean fold rise (GMFR) of antibody titers
time frame: day 1 and day 29
description: GMFR of antibody titers against each vaccine virus strain from day 1 to day 29.
measure: Magnitude of T-cell response
time frame: day 1 , day 15 and day 29
description: Magnitude of T-cell response (SI values) against influenza vaccine on day 1, day 15 and day 29.
measure: Frequency and severity of local and systemic adverse events following vaccination
time frame: day 1 to day 29
arm group label: Laser assisted epidermal application
arm group type: Experimental
description: Laser pretreatment: 4 adjacent areas of 2 cm² each (14mm x 14 mm) will be pretreated with an Erbium Yttrium Aluminium Garnet laser (22,7 J/cm², 2 pulses, Density: 5%) generating micropores with a depth of approximately 91 µm.
0,1 ml of Intanza (15 µg, seasonal trivalent influenza vaccine) will be topically administered on the laser-treated area.
arm group label: Intradermal application
arm group type: Active Comparator
description: 0,1 ml of Intanza (15 µg, seasonal trivalent influenza vaccine) will be intradermally injected in the deltoid area.
intervention type: Biological
intervention name: seasonal influenza vaccine
description: influenza vaccine containing 15 µg haemagglutinin of three seasonal influenza virus strains recommended by WHO
arm group label: Intradermal application
arm group label: Laser assisted epidermal application
other name: INTANZA
intervention type: Device
intervention name: fractional Er:Yag laser
description: Fraction laser device to apply micorpores of defined depth and density into skin.
arm group label: Laser assisted epidermal application
other name: Pantec P.L.E.A.S.E.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Influenza, Human