<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/NCT01707537</url>
  </required_header>
  <id_info>
    <org_study_id>UBC101</org_study_id>
    <nct_id>NCT01707537</nct_id>
  </id_info>
  <brief_title>To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men</brief_title>
  <acronym>OCV</acronym>
  <official_title>Phase I Study to Determine the Safety and Immunogenicity of Euvichol(Oral Cholera Prevention Vaccine)in Healthy Adult Men ; Open, Non-comparative Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EuBiologics Co.,Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto Universitario IVI</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>EuBiologics Co.,Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in&#xD;
      Healthy Adult Men&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical trial is open, non-comparative phase 1 clinical studies in healthy men and has&#xD;
      been designed to determine the safety and immunogenicity of Euvichol(Oral cholera vaccine)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety(proportion of subjects with adverse events)</measure>
    <time_frame>From the date of the first orally administered for 4 weeks after the second dose</time_frame>
    <description>The proportion of all adverse event and serious adverse event which were occured during the entire study period is analyzed and casuality between severity and investigational product is presented.&#xD;
Check the vital signs, physical examination and clinical laboratory tests</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity(vibriocidal antibody assay)</measure>
    <time_frame>Baseline(before the administration), 14 days after first dose, 14 days after second dose</time_frame>
    <description>Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Prevention Harmful Effects</condition>
  <arm_group>
    <arm_group_label>Euvichol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Euvichol is a homogeneous suspension of inactivated suitable strains of Vibrio cholera serogroup O1 and O139. Euvichol is Yellow to yellowish colour.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Euvichol</intervention_name>
    <description>1.5mL/vial, 1vial at 2-week intervals twice</description>
    <arm_group_label>Euvichol</arm_group_label>
    <other_name>Oral Cholerae Vaccine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult men over 20years of age&#xD;
&#xD;
          -  More than 45kg body weight and ideal body weight within ±20% of the weight&#xD;
&#xD;
          -  Screening was conducted within 14 days of investigational drug administration (Vital&#xD;
             Sign &amp; Physical Examination, hematology and blood coagulation tests, blood chemistry&#xD;
             tests, urinalysis, 12-lead ECG, etc.), the results at the discretion of the&#xD;
             investigator deemed suitable for participation in clinical trials&#xD;
&#xD;
          -  Written consent person who determines to participate in a clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A person who showed hypersensitivity when other preventive vaccination in the past&#xD;
&#xD;
          -  A person who have received cholera vaccine in the past&#xD;
&#xD;
          -  A person who had a febrile illness or infection disease, or have received antibiotics&#xD;
             within 2weeks before the start of the experiment&#xD;
&#xD;
          -  A person who had gastrointestinal symptoms such as diarrhea, abdominal pain, or have&#xD;
             been received prescription drug within one week before the start of the experiment&#xD;
&#xD;
          -  A person who was lasted for more than two weeks of symptoms such as diarrhea,&#xD;
             abdominal pain within 6months before the start of the experiment&#xD;
&#xD;
          -  A person who donate whole blood or component of blood within one months before the&#xD;
             start of the experiment if the donors&#xD;
&#xD;
          -  A person who received other preventive vaccine within 2months before the start of the&#xD;
             experiment&#xD;
&#xD;
          -  A person who received blood products of immune globulin preparations within 3months&#xD;
             before the start of the experiment&#xD;
&#xD;
          -  A person who has immune function disorders or are receiving immunosuppressive&#xD;
             treatment&#xD;
&#xD;
          -  A person who has chronic illness in progress&#xD;
&#xD;
          -  Ongoing drug and alcohol abuse(Not more than 28 units/week for drinking)&#xD;
&#xD;
          -  A person who participate in clinical trials treated with the investigational drug&#xD;
             within 2months before the start of the experiment&#xD;
&#xD;
          -  A person who is difficult to participate in this clinical trials as the discretion of&#xD;
             the investigator&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong J Hee, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chungnam National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <state>Chungnam</state>
        <zip>301-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>February 18, 2013</last_update_submitted>
  <last_update_submitted_qc>February 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 20, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OCV</keyword>
  <keyword>cholera</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholera</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</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/NCT01707537
org study id: UBC101
nct id: NCT01707537
lead sponsor: 
collaborator: 
has dmc: Yes
To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in
      Healthy Adult Men
This clinical trial is open, non-comparative phase 1 clinical studies in healthy men and has
      been designed to determine the safety and immunogenicity of Euvichol(Oral cholera vaccine)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Safety(proportion of subjects with adverse events)
time frame: From the date of the first orally administered for 4 weeks after the second dose
description: The proportion of all adverse event and serious adverse event which were occured during the entire study period is analyzed and casuality between severity and investigational product is presented.
Check the vital signs, physical examination and clinical laboratory tests
measure: Immunogenicity(vibriocidal antibody assay)
time frame: Baseline(before the administration), 14 days after first dose, 14 days after second dose
description: Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline
arm group label: Euvichol
arm group type: Experimental
description: Euvichol is a homogeneous suspension of inactivated suitable strains of Vibrio cholera serogroup O1 and O139. Euvichol is Yellow to yellowish colour.
intervention type: Biological
intervention name: Euvichol
description: 1.5mL/vial, 1vial at 2-week intervals twice
arm group label: Euvichol
other name: Oral Cholerae Vaccine
criteria: 
gender: Male
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hong J Hee, Ph.D
role: Principal Investigator
affiliation: Chungnam National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Cholera
mesh term: Vaccines