<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/NCT03035370</url>
  </required_header>
  <id_info>
    <org_study_id>VBEST</org_study_id>
    <nct_id>NCT03035370</nct_id>
  </id_info>
  <brief_title>Viaskin Pertussis Vaccine Trial</brief_title>
  <official_title>A Phase I Dose Escalation Randomized, Double-blind, Placebo-controlled Safety and Immunogenicity Trial of the Reactivation of Pertussis Toxin Immunity With the Viaskin Epicutaneous Delivery System in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DBV Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>DBV Technologies</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a Phase I, first in human, monocenter study, aiming at assessing the safety and&#xD;
      immunogenicity of a genetically detoxified pertussis toxin (PT) when administered via the&#xD;
      cutaneous route with Viaskin patches to healthy volunteers at 2 different doses of 25 mcg or&#xD;
      50 mcg PT protein compared to Viaskin placebo.&#xD;
&#xD;
      Two cohorts of 30 subjects will be successively enrolled. Safety of the product will be&#xD;
      assessed throughout the 10-week study and its immunogenicity will be assessed at regular&#xD;
      intervals with collection of blood samples for immunological analyses.&#xD;
&#xD;
      Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will&#xD;
      receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure the optimal&#xD;
      recall of their immunity against pertussis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2016</start_date>
  <completion_date type="Actual">April 25, 2018</completion_date>
  <primary_completion_date type="Actual">April 25, 2018</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events (AE).</measure>
    <time_frame>From Day 0 to Day 70.</time_frame>
    <description>Solicited AEs occurring from the time of each application through 14 days following Viaskin PT application;&#xD;
Unsolicited AEs from the time of application through 28 days following the 1st application;&#xD;
Serious Adverse Events from the time of the inform consent form signature through the final study visit of subject.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PT-specific antibody response (anti-PT IgG antibodies and PT-specific neutralizing antibodies).</measure>
    <time_frame>Day 14, Day 28, Day 42, Day 70.</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Whooping Cough</condition>
  <arm_group>
    <arm_group_label>Viaskin PT 25 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Viaskin PT 25 mcg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Viaskin PT 50 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Viaskin PT 50 mcg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Viaskin PT Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Viaskin PT Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Viaskin PT 25 mcg</intervention_name>
    <description>Two applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14).</description>
    <arm_group_label>Viaskin PT 25 mcg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Viaskin PT 50 mcg</intervention_name>
    <description>Two applications of Viaskin 50 mcg PT at a 2-week interval (D0 and D14).</description>
    <arm_group_label>Viaskin PT 50 mcg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Viaskin PT Placebo</intervention_name>
    <description>Two applications of Viaskin PT Placebo at a 2-week interval (D0 and D14).</description>
    <arm_group_label>Viaskin PT Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Boostrix™</intervention_name>
    <description>Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure the optimal recall of their immunity against pertussis.</description>
    <arm_group_label>Viaskin PT 25 mcg</arm_group_label>
    <arm_group_label>Viaskin PT 50 mcg</arm_group_label>
    <arm_group_label>Viaskin PT Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has provided written informed consent before enrollment;&#xD;
&#xD;
          -  Adult male or female, ages 18 to 40 years (inclusive) at the time of enrollment;&#xD;
&#xD;
          -  Non-pregnant, non-lactating female;&#xD;
&#xD;
          -  Free of clinically significant health problems, as determined by pertinent medical&#xD;
             history and clinical examination at study screening;&#xD;
&#xD;
          -  With documented history of pertussis immunization (at least 4 doses);&#xD;
&#xD;
          -  Women of childbearing potential with a negative pregnancy test at entry;&#xD;
&#xD;
          -  Females of childbearing potential who are willing to use an effective method of&#xD;
             contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior dTpa immunization within the last 10 years or prior dT immunization within the&#xD;
             last 2 years, or any other investigational vaccine likely to impact on interpretation&#xD;
             of the trial data;&#xD;
&#xD;
          -  Suspected or confirmed pertussis infection within the last 10 years or documented&#xD;
             pertussis infection in a household member within the last 10 years;&#xD;
&#xD;
          -  Receipt of licensed vaccines within 14 days of planned study immunization (30 days for&#xD;
             live vaccines) or ongoing participation in another clinical interventional trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire Anne Siegrist, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Faculty (UNIGE) and University hospital of Geneva , Center of Vaccinology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Vaccinology Medical faculty UNIGE and University of Geneva (HUG)</name>
      <address>
        <city>Geneva</city>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>March 15, 2016</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>February 28, 2020</last_update_submitted>
  <last_update_submitted_qc>February 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pertussis</keyword>
  <keyword>Epicutaneous ImmunoTherapy (EPIT)</keyword>
  <keyword>Vaccine</keyword>
  <keyword>Viaskin PT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Whooping Cough</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03035370
org study id: VBEST
nct id: NCT03035370
lead sponsor: 
collaborator: 
has dmc: Yes
The study is a Phase I, first in human, monocenter study, aiming at assessing the safety and
      immunogenicity of a genetically detoxified pertussis toxin (PT) when administered via the
      cutaneous route with Viaskin patches to healthy volunteers at 2 different doses of 25 mcg or
      50 mcg PT protein compared to Viaskin placebo.

      Two cohorts of 30 subjects will be successively enrolled. Safety of the product will be
      assessed throughout the 10-week study and its immunogenicity will be assessed at regular
      intervals with collection of blood samples for immunological analyses.

      Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will
      receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure the optimal
      recall of their immunity against pertussis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of Treatment-Emergent Adverse Events (AE).
time frame: From Day 0 to Day 70.
description: Solicited AEs occurring from the time of each application through 14 days following Viaskin PT application;
Unsolicited AEs from the time of application through 28 days following the 1st application;
Serious Adverse Events from the time of the inform consent form signature through the final study visit of subject.
measure: PT-specific antibody response (anti-PT IgG antibodies and PT-specific neutralizing antibodies).
time frame: Day 14, Day 28, Day 42, Day 70.
arm group label: Viaskin PT 25 mcg
arm group type: Experimental
description: Viaskin PT 25 mcg
arm group label: Viaskin PT 50 mcg
arm group type: Experimental
description: Viaskin PT 50 mcg
arm group label: Viaskin PT Placebo
arm group type: Placebo Comparator
description: Viaskin PT Placebo
intervention type: Biological
intervention name: Viaskin PT 25 mcg
description: Two applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14).
arm group label: Viaskin PT 25 mcg
intervention type: Biological
intervention name: Viaskin PT 50 mcg
description: Two applications of Viaskin 50 mcg PT at a 2-week interval (D0 and D14).
arm group label: Viaskin PT 50 mcg
intervention type: Biological
intervention name: Viaskin PT Placebo
description: Two applications of Viaskin PT Placebo at a 2-week interval (D0 and D14).
arm group label: Viaskin PT Placebo
intervention type: Biological
intervention name: Boostrix™
description: Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure the optimal recall of their immunity against pertussis.
arm group label: Viaskin PT 25 mcg
arm group label: Viaskin PT 50 mcg
arm group label: Viaskin PT Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Claire Anne Siegrist, M.D
role: Principal Investigator
affiliation: Medical Faculty (UNIGE) and University hospital of Geneva , Center of Vaccinology
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Whooping Cough
sharing ipd: Yes