<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/NCT01688297</url>
  </required_header>
  <id_info>
    <org_study_id>VXA02-001 &amp; VXA02-003</org_study_id>
    <nct_id>NCT01688297</nct_id>
  </id_info>
  <brief_title>Safety Study of an Oral Vaccine to Prevent Seasonal Influenza</brief_title>
  <official_title>Randomized Phase 1 Double-Blinded Placebo Controlled Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Seasonal Influenza A Vaccine and dsRNA Adjuvant Administered Orally to Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vaxart</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vaxart</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine&#xD;
      tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded&#xD;
      trial at a single site. The study was conducted under two separate protocols. Initially&#xD;
      single administrations at two dose levels (low dose and mid dose) of the oral vaccine was&#xD;
      tested in a placebo controlled study (37 subjects). And subsequently a single high dose of&#xD;
      the oral vaccine was tested in a separate placebo-controlled study (24 subjects).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low and mid dose study was conducted under protocol number VXA02-001&#xD;
&#xD;
      High dose study was conducted under protocol number VXA02-003&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">May 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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events</measure>
    <time_frame>One year following last vaccination</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Magnitude of humoral immune response to influenza as measured by functional assays</measure>
    <time_frame>28 Days and 180 Days post-vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnitude of cellular immune responses to influenza as measured by functional assays</measure>
    <time_frame>28 Days and 180 Days post-vaccination</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Low Dose VXA-A1.1 Oral Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VXA Placebo Tablet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral tablets of the same size and number as the vaccine tablet doses. Placebo arms were included during enrollment of each of the experimental dose groups to maintain the double-blind study design.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium Dose VXA-A1.1 Oral Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses of replication incompetent adenovirus vaccine given in an oral tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dose VXA-A1.1 Oral Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One dose of replication incompetent adenovirus given in an oral tablet dose. This dose was studied under protocol VXA02-003.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VXA-A1.1 Oral Vaccine</intervention_name>
    <description>One or two doses of replication incompetent adenovirus oral tablet vaccine</description>
    <arm_group_label>High Dose VXA-A1.1 Oral Vaccine</arm_group_label>
    <arm_group_label>Low Dose VXA-A1.1 Oral Vaccine</arm_group_label>
    <arm_group_label>Medium Dose VXA-A1.1 Oral Vaccine</arm_group_label>
    <other_name>Ad-HA-dsRNA (VXA-A1.1)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VXA Placebo Tablet</intervention_name>
    <description>Off-white tablets similarly formulated to the active drug product tablets.</description>
    <arm_group_label>VXA Placebo Tablet</arm_group_label>
    <other_name>Placebo Control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In good health as established by medical history, physical examination, and laboratory&#xD;
             testing at the time of enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive for H1 influenza by HAI.&#xD;
&#xD;
          -  Has had an influenza vaccine in the past 2 years.&#xD;
&#xD;
          -  Current history of chronic alcohol consumption and/or illicit and/or recreational drug&#xD;
             use.&#xD;
&#xD;
          -  History of any confirmed or suspected immunodeficient or immunosuppressive condition&#xD;
&#xD;
          -  Positive serology for HIV, HCV, or HBV&#xD;
&#xD;
          -  Previous serious reactions to vaccination such as anaphylaxis, respiratory problems,&#xD;
             hives, or abdominal pain.&#xD;
&#xD;
          -  History of irritable bowel disease or other inflammatory digestive or gastrointestinal&#xD;
             conditions that could affect the intended distribution of the vaccine targeting the&#xD;
             mucosa of the small intestine&#xD;
&#xD;
          -  Use of proton pump inhibitors(Nexium, Prilosec).&#xD;
&#xD;
          -  Stool sample with occult blood at baseline exam&#xD;
      </textblock>
    </criteria>
    <gender>All</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>
  <overall_official>
    <last_name>Apinya Vutikullird, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>WCCT</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>WCCT</name>
      <address>
        <city>Cypress</city>
        <state>California</state>
        <zip>90630</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Liebowitz D, Lindbloom JD, Brandl JR, Garg SJ, Tucker SN. High titre neutralising antibodies to influenza after oral tablet immunisation: a phase 1, randomised, placebo-controlled trial. Lancet Infect Dis. 2015 Sep;15(9):1041-1048. doi: 10.1016/S1473-3099(15)00266-2.</citation>
    <PMID>26333337</PMID>
  </results_reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>May 11, 2017</last_update_submitted>
  <last_update_submitted_qc>May 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>H1N1</keyword>
  <keyword>flu</keyword>
  <keyword>seasonal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT01688297
org study id: VXA02-001 & VXA02-003
nct id: NCT01688297
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine
      tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded
      trial at a single site. The study was conducted under two separate protocols. Initially
      single administrations at two dose levels (low dose and mid dose) of the oral vaccine was
      tested in a placebo controlled study (37 subjects). And subsequently a single high dose of
      the oral vaccine was tested in a separate placebo-controlled study (24 subjects).
Low and mid dose study was conducted under protocol number VXA02-001

      High dose study was conducted under protocol number VXA02-003
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events
time frame: One year following last vaccination
measure: Magnitude of humoral immune response to influenza as measured by functional assays
time frame: 28 Days and 180 Days post-vaccination
measure: Magnitude of cellular immune responses to influenza as measured by functional assays
time frame: 28 Days and 180 Days post-vaccination
arm group label: Low Dose VXA-A1.1 Oral Vaccine
arm group type: Experimental
description: Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation.
arm group label: VXA Placebo Tablet
arm group type: Placebo Comparator
description: Oral tablets of the same size and number as the vaccine tablet doses. Placebo arms were included during enrollment of each of the experimental dose groups to maintain the double-blind study design.
arm group label: Medium Dose VXA-A1.1 Oral Vaccine
arm group type: Experimental
description: Two doses of replication incompetent adenovirus vaccine given in an oral tablet
arm group label: High Dose VXA-A1.1 Oral Vaccine
arm group type: Experimental
description: One dose of replication incompetent adenovirus given in an oral tablet dose. This dose was studied under protocol VXA02-003.
intervention type: Biological
intervention name: VXA-A1.1 Oral Vaccine
description: One or two doses of replication incompetent adenovirus oral tablet vaccine
arm group label: High Dose VXA-A1.1 Oral Vaccine
arm group label: Low Dose VXA-A1.1 Oral Vaccine
arm group label: Medium Dose VXA-A1.1 Oral Vaccine
other name: Ad-HA-dsRNA (VXA-A1.1)
intervention type: Biological
intervention name: VXA Placebo Tablet
description: Off-white tablets similarly formulated to the active drug product tablets.
arm group label: VXA Placebo Tablet
other name: Placebo Control
criteria: 
gender: All
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.
last name: Apinya Vutikullird, DO
role: Principal Investigator
affiliation: WCCT
facility: 
country: United States
citation: Liebowitz D, Lindbloom JD, Brandl JR, Garg SJ, Tucker SN. High titre neutralising antibodies to influenza after oral tablet immunisation: a phase 1, randomised, placebo-controlled trial. Lancet Infect Dis. 2015 Sep;15(9):1041-1048. doi: 10.1016/S1473-3099(15)00266-2.
PMID: 26333337
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No