<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/NCT03020771</url>
  </required_header>
  <id_info>
    <org_study_id>MON116.40.1</org_study_id>
    <nct_id>NCT03020771</nct_id>
  </id_info>
  <brief_title>Phase I Study to Evaluate Basic Pharmacodynamic, Pharmacological and Toxicological Effects of the Newly Developed Crimean-Congo Hemorrhagic Fever Vaccine for Humans</brief_title>
  <official_title>Phase I Study to Evaluate Basic Pharmacodynamic, Pharmacological and Toxicological Effects of the Newly Developed Crimean-Congo Hemorrhagic Fever Vaccine for Humans, Prepared in Cell Culture and Inactivated With Formalin, and Administered Subcutaneously or Intramuscularly With Two Different Doses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Scientific and Technological Research Council of Turkey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MonitorCRO</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Scientific and Technological Research Council of Turkey</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study covers the first trial of the Crimean-Congo Hemorrhagic fever virus (CKKA) vaccine&#xD;
      on humans (healthy volunteers), which has been developed in Turkey and has completed&#xD;
      preclinical toxicology studies to be performed on experimental animals. Also, this study is a&#xD;
      Phase I, randomized, double-blind, national, single-center, placebo-controlled study that is&#xD;
      designed to evaluate the safety and efficacy of the CKKA vaccine. A total of 60 (12 + 48)&#xD;
      healthy male and/or female volunteers will be participating in this study, and the study is&#xD;
      planned to last approximately one year.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of the IMP in terms of number and frequency of any adverse events, any abnormal findings in physical examinations, ECGs, and laboratory parameters occurred during the follow up period.</measure>
    <time_frame>One year follow up</time_frame>
    <description>The safety parameters planned for this experimental vaccine will be all adverse events experienced by the volunteers or not identified by the volunteer and identified resulting from physical examinations or laboratory tests or ECG by the investigators.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>One year follow up</time_frame>
    <description>This secondary outcome will be performed at every humoral and cellular level after each immunization, based on immunological responses.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Crimean-Congo Hemorrhagic Fever</condition>
  <arm_group>
    <arm_group_label>5 mcg IM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>5 mcg SC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>5 mcg IM control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.9% NaCl Solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 mcg SC control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.9% NaCl Solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 mcg IM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>10 mcg SC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>KIRIM-KONGO-VAX</intervention_name>
    <description>Crimean-Congo Hemorrhagic Fever Vaccine</description>
    <arm_group_label>10 mcg IM</arm_group_label>
    <arm_group_label>10 mcg SC</arm_group_label>
    <arm_group_label>5 mcg IM</arm_group_label>
    <arm_group_label>5 mcg SC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>5 mcg IM control</arm_group_label>
    <arm_group_label>5 mcg SC control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, white in the 18-55 age range, men and/or women who agree not to become&#xD;
             pregnant until 2 months after the start of the last vaccination&#xD;
&#xD;
          -  Body weights are at limits to exclude anorexia or obesity (The BMI limits accepted for&#xD;
             this study are 18.5-30 kg /m2)&#xD;
&#xD;
          -  According to clinical and standard laboratory tests, physical and spiritually healthy&#xD;
             volunteers.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The 20 days before the study any vaccination applied volunteers&#xD;
&#xD;
          -  Persons with clinically significant liver, kidney, gastrointestinal, cardiovascular,&#xD;
             psychiatric, pulmonary, hematologic, endocrinological, or other significant acute or&#xD;
             chronic abnormalities in the medical history of the volunteer or in the examination.&#xD;
&#xD;
          -  Volunteers who have previously had any pulmonary infection or have previously used&#xD;
             immunosuppressive drugs (including corticosteroids) for any reason&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aydın Erenmemisoglu, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TC Erciyes University</affiliation>
  </overall_official>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>October 16, 2017</last_update_submitted>
  <last_update_submitted_qc>October 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Scientific and Technological Research Council of Turkey</investigator_affiliation>
    <investigator_full_name>Aydin Erenmemisoglu</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>Crimean-congo hemorrhagic fever</keyword>
  <keyword>vaccine</keyword>
  <keyword>human</keyword>
  <keyword>phase I</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhagic Fevers, Viral</mesh_term>
    <mesh_term>Hemorrhagic Fever, Crimean</mesh_term>
    <mesh_term>Fever</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/NCT03020771
org study id: MON116.40.1
nct id: NCT03020771
lead sponsor: 
collaborator: 
has dmc: Yes
This study covers the first trial of the Crimean-Congo Hemorrhagic fever virus (CKKA) vaccine
      on humans (healthy volunteers), which has been developed in Turkey and has completed
      preclinical toxicology studies to be performed on experimental animals. Also, this study is a
      Phase I, randomized, double-blind, national, single-center, placebo-controlled study that is
      designed to evaluate the safety and efficacy of the CKKA vaccine. A total of 60 (12 + 48)
      healthy male and/or female volunteers will be participating in this study, and the study is
      planned to last approximately one year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Safety of the IMP in terms of number and frequency of any adverse events, any abnormal findings in physical examinations, ECGs, and laboratory parameters occurred during the follow up period.
time frame: One year follow up
description: The safety parameters planned for this experimental vaccine will be all adverse events experienced by the volunteers or not identified by the volunteer and identified resulting from physical examinations or laboratory tests or ECG by the investigators.
measure: Immunogenicity
time frame: One year follow up
description: This secondary outcome will be performed at every humoral and cellular level after each immunization, based on immunological responses.
arm group label: 5 mcg IM
arm group type: Active Comparator
arm group label: 5 mcg SC
arm group type: Active Comparator
arm group label: 5 mcg IM control
arm group type: Placebo Comparator
description: 0.9% NaCl Solution
arm group label: 5 mcg SC control
arm group type: Placebo Comparator
description: 0.9% NaCl Solution
arm group label: 10 mcg IM
arm group type: Active Comparator
arm group label: 10 mcg SC
arm group type: Active Comparator
intervention type: Biological
intervention name: KIRIM-KONGO-VAX
description: Crimean-Congo Hemorrhagic Fever Vaccine
arm group label: 10 mcg IM
arm group label: 10 mcg SC
arm group label: 5 mcg IM
arm group label: 5 mcg SC
intervention type: Other
intervention name: Placebo
arm group label: 5 mcg IM control
arm group label: 5 mcg SC control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aydın Erenmemisoglu, MD PhD
role: Principal Investigator
affiliation: TC Erciyes University
responsible party type: Principal Investigator
investigator affiliation: The Scientific and Technological Research Council of Turkey
investigator full name: Aydin Erenmemisoglu
investigator title: MD PhD
mesh term: Hemorrhagic Fevers, Viral
mesh term: Hemorrhagic Fever, Crimean
mesh term: Fever