<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/NCT03017378</url>
  </required_header>
  <id_info>
    <org_study_id>VIT-I-01/2013</org_study_id>
    <nct_id>NCT03017378</nct_id>
  </id_info>
  <brief_title>Reactogenicity, Safety and Immunogenicity of a TB/FLU-01L Tuberculosis Vaccine</brief_title>
  <official_title>A Randomized, Open Clinical Trial Phase 1 Vaccine TB/FLU-01L by Intranasal and Sublingual Application for Specific Immunotherapy Pulmonary Tuberculosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Research Institute for Biological Safety Problems</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Kazakhstan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Research Institute of Influenza, Russia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Research Institute for Biological Safety Problems</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a single centre, phase I, open, randomized, by intranasal and sublingual&#xD;
      application trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21)&#xD;
      TB/FLU-01L tuberculosis vaccine in BCG-vaccinated healthy adult subjects aged 18-50 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events (AE) - Immediate reactions</measure>
    <time_frame>Two hours</time_frame>
    <description>Commonly Solicited Local reactions associated with injections: pain, erythema/redness, swelling, induration, bruising at the injection site.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Solicited local and systemic reactions</measure>
    <time_frame>Greater than 2 hours after administration of any dose of vaccine through 7 days following any dose</time_frame>
    <description>Commonly Solicited general symptoms: fever (oral temperature ≥ 38.0°C), chills, muscle aches/myalgia, arthralgia, fatigue, malaise, headache, rash, sweating, nausea, vomiting, diarrhea and potential indicators of oculo-respiratory syndrome* (ORS).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Unsolicited AEs</measure>
    <time_frame>Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose</time_frame>
    <description>Unsolicited AEs are any untoward medical occurrence in the subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serious adverse events (SAEs), including abnormal laboratory findings</measure>
    <time_frame>Three weeks of receipt of any dose</time_frame>
    <description>Serious adverse events (SAEs) are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>TB/FLU-01L (intranasal application)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vaccine safety analysis of TB/FLU-01L at double intranasal application in healthy volunteers aged 18 to 50 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TB/FLU-01L (sublingual application)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vaccine safety analysis of TB/FLU-01L at double sublingual application in healthy volunteers aged 18 to 50 years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TB/FLU-01L</intervention_name>
    <description>TB / FLU-01L (intranasal application)</description>
    <arm_group_label>TB/FLU-01L (intranasal application)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TB/FLU-01L</intervention_name>
    <description>TB/FLU-01L (sublingual application)</description>
    <arm_group_label>TB/FLU-01L (sublingual application)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy BCG-vaccinated male or female adult 18 through 50 years of age at the&#xD;
             enrollment visit.&#xD;
&#xD;
          -  Literate and willing to provide written informed consent.&#xD;
&#xD;
          -  A signed informed consent.&#xD;
&#xD;
          -  Capable and willing to complete diary cards and willing to return for all follow-up&#xD;
             visits.&#xD;
&#xD;
          -  For females, willing to take reliable birth control measures throughout the entire&#xD;
             period of participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical, radiological (chest X-ray) or laboratory evidence of active or past TB&#xD;
             disease.&#xD;
&#xD;
          -  Current or past administration of anti-TB therapy.&#xD;
&#xD;
          -  History of contact with TB patients.&#xD;
&#xD;
          -  Positive QuantiFERON-TB Gold test.&#xD;
&#xD;
          -  BCG vaccination in less than 6 months prior to study.&#xD;
&#xD;
          -  Practice of nasal irrigation on a regular basis within the past six months or has&#xD;
             engaged in nasal irrigation within two weeks prior to enrollment.&#xD;
&#xD;
          -  Recent history of frequent nose bleeds (&gt;5 within the past year).&#xD;
&#xD;
          -  Clinically relevant abnormal paranasal anatomy.&#xD;
&#xD;
          -  Recent history (within the past month) of rhino or sinus surgery, or surgery for any&#xD;
             traumatic injury of the nose.&#xD;
&#xD;
          -  Current or recent (within two weeks of enrollment) acute respiratory illness with or&#xD;
             without fever.&#xD;
&#xD;
          -  Hypersensitivity after previous administration of any vaccine.&#xD;
&#xD;
          -  History of chronic alcohol abuse and/or illegal drug use.&#xD;
&#xD;
          -  Any clinically significant abnormal laboratory finding.&#xD;
&#xD;
          -  A positive pregnancy test for all women of childbearing potential.&#xD;
&#xD;
          -  Administration of immunosuppressive drugs or other immune modifying drugs within 4&#xD;
             weeks prior to study enrollment.&#xD;
&#xD;
          -  Acute or chronic clinically significant pulmonary disease, cardiovascular disease,&#xD;
             gastrointestinal disease, liver disease, neurological illness, liver disease, blood&#xD;
             disease, skin disorder, endocrine disorder, neurological illness and psychiatric&#xD;
             disorder as determined by medical history, physical examination or clinical laboratory&#xD;
             screening tests, which in the opinion of the investigator, might interfere with the&#xD;
             study objectives.&#xD;
&#xD;
          -  History of leukemia or any other blood or solid organ cancer.&#xD;
&#xD;
          -  Seropositive for HIV, hepatitis B surface antigen and/or hepatitis C antibodies.&#xD;
&#xD;
          -  Receipt of antivirals, antibiotics, immunoglobulins or other blood products within 4&#xD;
             weeks prior to study enrollment or planned receipt of such products during the period&#xD;
             of subject participation in the study.&#xD;
&#xD;
          -  Participation in another clinical trial within the previous three months or planned&#xD;
             enrollment in such a trial during the period of this study.&#xD;
&#xD;
          -  Subjects who are, in the opinion of the investigator, at significantly increased risk&#xD;
             of non-cooperation with requirements of the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Berik M Khairullin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Institute for Biological Safety Problems</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Center for Tuberculosis Problems, Kazakhstan</name>
      <address>
        <city>Almaty Qalasy</city>
        <state>Almaty</state>
        <zip>050000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kazakhstan</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>influenza vector</keyword>
  <keyword>tuberculosis</keyword>
  <keyword>vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03017378
org study id: VIT-I-01/2013
nct id: NCT03017378
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The study is a single centre, phase I, open, randomized, by intranasal and sublingual
      application trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21)
      TB/FLU-01L tuberculosis vaccine in BCG-vaccinated healthy adult subjects aged 18-50 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Events (AE) - Immediate reactions
time frame: Two hours
description: Commonly Solicited Local reactions associated with injections: pain, erythema/redness, swelling, induration, bruising at the injection site.
measure: Solicited local and systemic reactions
time frame: Greater than 2 hours after administration of any dose of vaccine through 7 days following any dose
description: Commonly Solicited general symptoms: fever (oral temperature ≥ 38.0°C), chills, muscle aches/myalgia, arthralgia, fatigue, malaise, headache, rash, sweating, nausea, vomiting, diarrhea and potential indicators of oculo-respiratory syndrome* (ORS).
measure: Unsolicited AEs
time frame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose
description: Unsolicited AEs are any untoward medical occurrence in the subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
measure: Serious adverse events (SAEs), including abnormal laboratory findings
time frame: Three weeks of receipt of any dose
description: Serious adverse events (SAEs) are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
arm group label: TB/FLU-01L (intranasal application)
arm group type: Active Comparator
description: Vaccine safety analysis of TB/FLU-01L at double intranasal application in healthy volunteers aged 18 to 50 years.
arm group label: TB/FLU-01L (sublingual application)
arm group type: Active Comparator
description: Vaccine safety analysis of TB/FLU-01L at double sublingual application in healthy volunteers aged 18 to 50 years.
intervention type: Biological
intervention name: TB/FLU-01L
description: TB / FLU-01L (intranasal application)
arm group label: TB/FLU-01L (intranasal application)
intervention type: Biological
intervention name: TB/FLU-01L
description: TB/FLU-01L (sublingual application)
arm group label: TB/FLU-01L (sublingual application)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Berik M Khairullin, PhD
role: Principal Investigator
affiliation: Research Institute for Biological Safety Problems
facility: 
country: Kazakhstan
responsible party type: Sponsor
mesh term: Tuberculosis
sharing ipd: Undecided