<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/NCT01698060</url>
  </required_header>
  <id_info>
    <org_study_id>VXA01-001subA</org_study_id>
    <nct_id>NCT01698060</nct_id>
  </id_info>
  <brief_title>Immunogenicity of ND1.1 by Delivery Directly to the Ileum</brief_title>
  <acronym>ICC H5</acronym>
  <official_title>An Open Label Phase I Substudy to Evaluate the Safety and Ability to Enhance Immunogenicity of ND1.1 by Delivery Directly to the Ileum Using the InteliSite® Companion Capsule in Healthy Adult Males</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vaxart</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vaxart</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the safety and tolerability of ND1.1, an adjuvanted&#xD;
      adenoviral-based avian influenza vaccine, when delivery is targeted to the ileum, using a&#xD;
      radio controlled capsule. The secondary objective is to evaluate the immune response&#xD;
      (cellular and humoral) of two doses of ND1.1 oral vaccine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</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</measure>
    <time_frame>1 year</time_frame>
    <description>Frequency and magnitude of adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>1 year</time_frame>
    <description>Antibody and T cell responses to HA</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Avian Influenza</condition>
  <arm_group>
    <arm_group_label>Intestinal Delivery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ND1.1</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ND1.1</intervention_name>
    <arm_group_label>Intestinal Delivery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able and willing to complete informed consent&#xD;
&#xD;
          -  Healthy, as established by medical history, physical exam, and laboratory assessments&#xD;
&#xD;
          -  Has normal bowel movements&#xD;
&#xD;
          -  Willing to abstain from caffeine and xanthine containing substances for 24 hours&#xD;
             before procedure until after discharge&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ability to donate up to 550 ml of blood over several months&#xD;
&#xD;
          -  Exposure to any investigational drug or vaccine 8 weeks prior to study&#xD;
&#xD;
          -  Has traveled to Asia within 8 weeks of enrollment&#xD;
&#xD;
          -  Abnormal ECG findings&#xD;
&#xD;
          -  History of irritable bowl or any other inflammatory gastrointestinal disorder&#xD;
&#xD;
          -  Any individual with increased risk for bowl obstruction&#xD;
&#xD;
          -  Radiation exposure above target values 50 mSv within the past 30 days or a cumulative&#xD;
             dose above 150 mSv in the past 12 months&#xD;
&#xD;
          -  History of substance abuse&#xD;
&#xD;
          -  Subject unwilling to use an approved method of contraception during study and for 2&#xD;
             months after study&#xD;
&#xD;
          -  Positive for HCV, HIV, or HBV&#xD;
&#xD;
          -  Presence of an implantable device that is sensitive to radio frequencies (e.g.&#xD;
             pacemakers)&#xD;
&#xD;
          -  History of an autoimmune disorder, or an immunosuppressive disorder&#xD;
&#xD;
          -  Stool sample with occult blood at baseline&#xD;
&#xD;
          -  Any other medical, psychiatric, social condition, or occupation, in the judgement of&#xD;
             the investigator, is a contraindication to the compliance of the protocol or informed&#xD;
             consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Liebowitz, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Vaxart, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Scintipharma</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>December 8, 2014</last_update_submitted>
  <last_update_submitted_qc>December 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prevention of Avian Influenza</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT01698060
org study id: VXA01-001subA
nct id: NCT01698060
lead sponsor: 
has dmc: No
The purpose of the study is to determine the safety and tolerability of ND1.1, an adjuvanted
      adenoviral-based avian influenza vaccine, when delivery is targeted to the ileum, using a
      radio controlled capsule. The secondary objective is to evaluate the immune response
      (cellular and humoral) of two doses of ND1.1 oral vaccine.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Safety
time frame: 1 year
description: Frequency and magnitude of adverse events
measure: Immunogenicity
time frame: 1 year
description: Antibody and T cell responses to HA
arm group label: Intestinal Delivery
arm group type: Experimental
description: ND1.1
intervention type: Biological
intervention name: ND1.1
arm group label: Intestinal Delivery
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Liebowitz, MD, PhD
role: Study Director
affiliation: Vaxart, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Influenza in Birds