<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/NCT02186977</url>
  </required_header>
  <id_info>
    <org_study_id>CP140465_2014_001_v5</org_study_id>
    <nct_id>NCT02186977</nct_id>
  </id_info>
  <brief_title>Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID</brief_title>
  <acronym>POC_VAX-ID</acronym>
  <official_title>Proof Of Concept Study: Immunogenicity and Safety of Hepatitis B Injection in the Dermis in Healthy Volunteers Using an Intradermal Injection Device (VAX-ID)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novosanis NV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novosanis NV</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A proof of concept (POC) study will be conducted in 44 volunteers that have been fully&#xD;
      vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and&#xD;
      immunogenicity of intradermal vaccination with hepatitis B surface vaccine antigen using a&#xD;
      newly developed intradermal injection device VAX-ID, compared to intramuscular and&#xD;
      intradermal (Mantoux technique) injection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects</measure>
    <time_frame>after 14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: solicited local and systemic reactions, unsolicited adverse events and Serious Adverse Events occurrence, intensity and relationship to vaccination of all Adverse Events reported during the 14-day follow-up period after the challenge dose</measure>
    <time_frame>during 14 days post vaccination</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Intramuscular group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intradermal group (Mantoux)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These subjects will receive one intradermal injection with mantoux technique in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur-MSD) will be injected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intradermal group (VAX-ID) A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These subjects will receive one intradermal injection with the newly developed intradermal injection device VAX-ID in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intradermal group (VAX-ID) B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These subjects will receive two intradermal injections with two newly developed intradermal injection devices VAX-ID in both forearms each 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VAX-ID</intervention_name>
    <description>0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection</description>
    <arm_group_label>Intradermal group (VAX-ID) A</arm_group_label>
    <arm_group_label>Intradermal group (VAX-ID) B</arm_group_label>
    <other_name>INTRADERMAL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)</intervention_name>
    <description>1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)</description>
    <arm_group_label>Intramuscular group</arm_group_label>
    <other_name>INTRAMUSCULAR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)</intervention_name>
    <description>0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection</description>
    <arm_group_label>Intradermal group (Mantoux)</arm_group_label>
    <other_name>MANTOUX_INTRADERMAL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy adults, checked anamnestically (based on medical history) at entry of the&#xD;
             study&#xD;
&#xD;
          -  18-35 years&#xD;
&#xD;
          -  vaccination status: fully vaccinated against hepatitis B at least 5 years ago, with&#xD;
             proof of vaccine response (to avoid non-response among the subjects). Subjects has to&#xD;
             ask for a document of this proof at the service occupational medicine of the&#xD;
             University of Antwerp.&#xD;
&#xD;
          -  capable of understanding, reading and writing Dutch&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other vaccination(s) 4 weeks before study onset&#xD;
&#xD;
          -  pregnancy and lactation (women will be questioned during anamnesis)&#xD;
&#xD;
          -  plan to have other vaccination during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre Van Damme, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for the Evaluation of Vaccination Vaccine &amp; Infectious Disease Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for the Evaluation of Vaccination Vaccine &amp; Infectious Disease Institute</name>
      <address>
        <city>Wilrijk</city>
        <state>Antwerp</state>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>March 27, 2017</last_update_submitted>
  <last_update_submitted_qc>March 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>immunogenicity</keyword>
  <keyword>safety</keyword>
  <keyword>proof of concept</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02186977
org study id: CP140465_2014_001_v5
nct id: NCT02186977
lead sponsor: 
has dmc: No
A proof of concept (POC) study will be conducted in 44 volunteers that have been fully
      vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and
      immunogenicity of intradermal vaccination with hepatitis B surface vaccine antigen using a
      newly developed intradermal injection device VAX-ID, compared to intramuscular and
      intradermal (Mantoux technique) injection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects
time frame: after 14 days
measure: Safety: solicited local and systemic reactions, unsolicited adverse events and Serious Adverse Events occurrence, intensity and relationship to vaccination of all Adverse Events reported during the 14-day follow-up period after the challenge dose
time frame: during 14 days post vaccination
arm group label: Intramuscular group
arm group type: Active Comparator
description: These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region.
arm group label: Intradermal group (Mantoux)
arm group type: Experimental
description: These subjects will receive one intradermal injection with mantoux technique in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur-MSD) will be injected.
arm group label: Intradermal group (VAX-ID) A
arm group type: Experimental
description: These subjects will receive one intradermal injection with the newly developed intradermal injection device VAX-ID in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected.
arm group label: Intradermal group (VAX-ID) B
arm group type: Experimental
description: These subjects will receive two intradermal injections with two newly developed intradermal injection devices VAX-ID in both forearms each 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected.
intervention type: Device
intervention name: VAX-ID
description: 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
arm group label: Intradermal group (VAX-ID) A
arm group label: Intradermal group (VAX-ID) B
other name: INTRADERMAL
intervention type: Drug
intervention name: 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)
description: 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)
arm group label: Intramuscular group
other name: INTRAMUSCULAR
intervention type: Drug
intervention name: 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)
description: 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
arm group label: Intradermal group (Mantoux)
other name: MANTOUX_INTRADERMAL
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pierre Van Damme, Prof
role: Principal Investigator
affiliation: Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Hepatitis B
mesh term: Hepatitis
sharing ipd: No