<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/NCT01675284</url>
  </required_header>
  <id_info>
    <org_study_id>CT-AI-11</org_study_id>
    <nct_id>NCT01675284</nct_id>
  </id_info>
  <brief_title>A Phase I Study to Evaluate the Safety, Reactogenicity, and Humoral Immune Responses to an Inactivated H5N1 Influenza Vaccine</brief_title>
  <official_title>A Phase I, Prospective, Randomized, Open Label, Observer-Blind, Single Center Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an Inactivated H5N1 Influenza Vaccine Produced in Madin-Darby Canine Kidney (MDCK) Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medigen Biotechnology Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medigen Biotechnology Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The focus of this study is to evaluate the safety, reactogenicity and humoral immune&#xD;
      responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg&#xD;
      HA to human subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since 1997, avian H5N1 influenza in Southeast Asia has caused several human infections and&#xD;
      has a high mortality rate. Experts warn that the next influenza pandemic is imminent and&#xD;
      could be severe and prevention and control will depend on the rapid production and worldwide&#xD;
      distribution of specific pandemic influenza candidate vaccines. An H5N1 influenza vaccine was&#xD;
      successfully produced from whole virus grown in MDCK (Madin-Darby canine kidney) cells. These&#xD;
      purified inactivated vaccine antigens were safe and could induce immune responses in animal&#xD;
      studies. Moreover, when formulated in aluminum phosphate a stronger response was generated&#xD;
      even at low doses in animals (Chong et al., 2008; Hu et al., 2008). However, further&#xD;
      investigations are necessary before their human safety and immunogenicity can be established.&#xD;
      This human phase I clinical study, therefore, evaluates the safety and immunogenicity of&#xD;
      adjuvanted H5N1 virion influenza vaccine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Signs and symptoms solicited by vaccination</measure>
    <time_frame>A 7-day follow-up period after each vaccine administration</time_frame>
    <description>Percentage, intensity, and relationship to vaccination of solicited local and general signs and symptoms during a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each administered vaccine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Signs and symptoms unsolicited by vaccination</measure>
    <time_frame>A 21-day follow-up period after each vaccine administration</time_frame>
    <description>Percentage, intensity, and relationship to vaccination of unsolicited local and general signs and symptoms during a 21-day follow-up period (i.e. day of vaccination and 20 subsequent days) after each administered vaccine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of adverse events and serious adverse events</measure>
    <time_frame>Up to 180 days after the first vaccine administration</time_frame>
    <description>Occurrence of overall adverse events and serious adverse events up to 180 days after the first administered vaccine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum antibody titers to H5N1 virus</measure>
    <time_frame>Day 0</time_frame>
    <description>Serum anti-HA antibody titers and neutralizing antibody titers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum antibody titers to H5N1 virus</measure>
    <time_frame>Day 21</time_frame>
    <description>Serum anti-HA antibody titers and neutralizing antibody titers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum antibody titers to H5N1 virus</measure>
    <time_frame>Day 42</time_frame>
    <description>Serum anti-HA antibody titers and neutralizing antibody titers.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Bird Flu</condition>
  <condition>Avian Influenza</condition>
  <condition>Influenza A(H5N1)</condition>
  <arm_group>
    <arm_group_label>Low Dosage AT-301</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7.5 µg hemagglutinin (HA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Middle Dosage AT-301</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 µg hemagglutinin (HA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dosage AT-301</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 µg hemagglutinin (HA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AT-301</intervention_name>
    <description>Inactivated H5N1 Influenza Virion Vaccine</description>
    <arm_group_label>High Dosage AT-301</arm_group_label>
    <arm_group_label>Low Dosage AT-301</arm_group_label>
    <arm_group_label>Middle Dosage AT-301</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female ≥20 and ≤60 years of age&#xD;
&#xD;
          -  In good health as determined by medical history, physical examination, and clinical&#xD;
             judgment of the investigator&#xD;
&#xD;
          -  Willing and able to comply with all required study visits and follow-up required by&#xD;
             this protocol&#xD;
&#xD;
          -  Must provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or potential exposure to avian influenza virus or any H5N1 HA antigen vaccine&#xD;
&#xD;
          -  Had any influenza vaccine within 6 months&#xD;
&#xD;
          -  Administered with any vaccine within 30 days&#xD;
&#xD;
          -  A history of hypersensitivity to vaccines or inflammatory or degenerative neurological&#xD;
             disease&#xD;
&#xD;
          -  Receiving chronic administration of immunosuppressants or other immune-modifying drugs&#xD;
             within 6 months&#xD;
&#xD;
          -  Known HIV, hepatitis B (HBsAg) or hepatitis C seropositivity&#xD;
&#xD;
          -  Any medical illness including clinically significant acute pulmonary, cardiovascular,&#xD;
             hepatic or renal functional abnormality, as determined by physical examination or&#xD;
             laboratory screening tests&#xD;
&#xD;
          -  Receiving immunoglobulins and/or any blood products within the three months&#xD;
&#xD;
          -  Acute disease at the time of enrolment&#xD;
&#xD;
          -  Psychiatric, addictive, or any disorder, which may compromise the ability to give a&#xD;
             truly informed consent for participation of this study or adequate compliance&#xD;
&#xD;
          -  Breast feeding or pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pan-Chyr Yang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>October 23, 2013</last_update_submitted>
  <last_update_submitted_qc>October 23, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 25, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Avian Influenza</keyword>
  <keyword>Influenza A Virus Subtype H5N1</keyword>
  <keyword>Inactivated H5N1 Influenza Virion Vaccine</keyword>
  <keyword>Phase I</keyword>
  <keyword>Preventive H5N1 vaccination</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Influenza in Birds</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/NCT01675284
org study id: CT-AI-11
nct id: NCT01675284
lead sponsor: 
has dmc: No
The focus of this study is to evaluate the safety, reactogenicity and humoral immune
      responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg
      HA to human subjects.
Since 1997, avian H5N1 influenza in Southeast Asia has caused several human infections and
      has a high mortality rate. Experts warn that the next influenza pandemic is imminent and
      could be severe and prevention and control will depend on the rapid production and worldwide
      distribution of specific pandemic influenza candidate vaccines. An H5N1 influenza vaccine was
      successfully produced from whole virus grown in MDCK (Madin-Darby canine kidney) cells. These
      purified inactivated vaccine antigens were safe and could induce immune responses in animal
      studies. Moreover, when formulated in aluminum phosphate a stronger response was generated
      even at low doses in animals (Chong et al., 2008; Hu et al., 2008). However, further
      investigations are necessary before their human safety and immunogenicity can be established.
      This human phase I clinical study, therefore, evaluates the safety and immunogenicity of
      adjuvanted H5N1 virion influenza vaccine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Signs and symptoms solicited by vaccination
time frame: A 7-day follow-up period after each vaccine administration
description: Percentage, intensity, and relationship to vaccination of solicited local and general signs and symptoms during a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each administered vaccine.
measure: Signs and symptoms unsolicited by vaccination
time frame: A 21-day follow-up period after each vaccine administration
description: Percentage, intensity, and relationship to vaccination of unsolicited local and general signs and symptoms during a 21-day follow-up period (i.e. day of vaccination and 20 subsequent days) after each administered vaccine.
measure: Occurrence of adverse events and serious adverse events
time frame: Up to 180 days after the first vaccine administration
description: Occurrence of overall adverse events and serious adverse events up to 180 days after the first administered vaccine.
measure: Serum antibody titers to H5N1 virus
time frame: Day 0
description: Serum anti-HA antibody titers and neutralizing antibody titers.
measure: Serum antibody titers to H5N1 virus
time frame: Day 21
description: Serum anti-HA antibody titers and neutralizing antibody titers.
measure: Serum antibody titers to H5N1 virus
time frame: Day 42
description: Serum anti-HA antibody titers and neutralizing antibody titers.
arm group label: Low Dosage AT-301
arm group type: Experimental
description: 7.5 µg hemagglutinin (HA)
arm group label: Middle Dosage AT-301
arm group type: Experimental
description: 15 µg hemagglutinin (HA)
arm group label: High Dosage AT-301
arm group type: Experimental
description: 30 µg hemagglutinin (HA)
intervention type: Biological
intervention name: AT-301
description: Inactivated H5N1 Influenza Virion Vaccine
arm group label: High Dosage AT-301
arm group label: Low Dosage AT-301
arm group label: Middle Dosage AT-301
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pan-Chyr Yang, MD, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Influenza in Birds