<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/NCT01673425</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 604-2010</org_study_id>
    <nct_id>NCT01673425</nct_id>
  </id_info>
  <brief_title>Evaluating Immune Response to Seasonal FluMist in Healthy Adults</brief_title>
  <official_title>Evaluating Immune Response to Seasonal FluMist in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Center for Occupational Health and Infection Control</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>US Department of Veterans Affairs</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>National Center for Occupational Health and Infection Control</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Live-Attenuated Influenza Vaccine (LAIV), also known as FluMist, has been shown to be&#xD;
      effective in children but less effective in adults. Our hypothesis is that this relative&#xD;
      failure is due to adults having enough anti-flu IgA antibody in nasal secretions to&#xD;
      neutralize the weakened vaccine virus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a VA-based study to evaluate serum and nasal wash antibody responses to seasonal LAIV&#xD;
      of healthy Veterans and VA employees between the ages of 20 and 49 years old.&#xD;
&#xD;
      Specific Aims&#xD;
&#xD;
        1. The primary aim of the study is to evaluate whether people with high mucosal IgA&#xD;
           antibodies against flu have a lower immune response to the seasonal LAIV.&#xD;
&#xD;
        2. The secondary objective is to determine whether the nasal wash viral neutralization data&#xD;
           predicts LAIV immunization failures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low accrual(4 completed subjects over 2 months)&amp; inconclusive nasal wash assays.&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IgA Antibody Titers</measure>
    <time_frame>Change from baseline in antibody titer at 6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Antibody Response to LAIV</measure>
    <time_frame>Change from baseline in serum antibody response at 6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Live Attenuated Influenza Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intervention study- all participants will receive LAIV instead of injectable flu vaccine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Live Attenuated Influenza Vaccine</intervention_name>
    <description>All participants will be given FluMist.</description>
    <arm_group_label>Live Attenuated Influenza Vaccine</arm_group_label>
    <other_name>FluMist</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medically eligible healthy men and women between the ages of 20 to 49 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A medical condition that places them at high risk for complications from influenza,&#xD;
             including those with chronic heart or lung disease, such as asthma or reactive airway&#xD;
             disease; people with medical conditions such as diabetes or kidney failure; or people&#xD;
             with illnesses that weaken the immune system, or who take medications that can weaken&#xD;
             the immune system.&#xD;
&#xD;
          -  A history of Guillain-Barré Syndrome that occurred after receiving influenza vaccine&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
          -  Have a severe allergy to chicken eggs or who are allergic to any of the nasal spray&#xD;
             vaccine components&#xD;
&#xD;
          -  Have had flu within the current flu season.&#xD;
&#xD;
          -  Have had a flu vaccine within the current flu season.&#xD;
&#xD;
          -  Have close contact with someone whose immune system is so weak they require care in a&#xD;
             protected environment (such as bone marrow transplant unit).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lewis J. Radonovich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Center for Occupational Health and Infection Control</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Malcom Randall VA Medical Center</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <results_first_submitted>July 29, 2014</results_first_submitted>
  <results_first_submitted_qc>September 2, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 4, 2014</results_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Influenza Vaccines</keyword>
  <keyword>Vaccines, Attenuated</keyword>
  <keyword>Immunity, Mucosal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Experimental: Live Attenuated Influenza Vaccine</title>
          <description>Single intervention study; all participants receive LAIV</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Live Attenuated Influenza Vaccine Study</title>
          <description>This study was terminated due to poor enrollment and inconclusive nasal wash samples. No analyses were performed.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>IgA Antibody Titers</title>
        <time_frame>Change from baseline in antibody titer at 6 weeks</time_frame>
        <population>This study was terminated due to poor enrollment. Analyses were not conducted due to inconclusive nasal wash samples.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Live Attenuated Influenza Vaccine</title>
            <description>Single Intervention Study</description>
          </group>
        </group_list>
        <measure>
          <title>IgA Antibody Titers</title>
          <population>This study was terminated due to poor enrollment. Analyses were not conducted due to inconclusive nasal wash samples.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Antibody Response to LAIV</title>
        <time_frame>Change from baseline in serum antibody response at 6 weeks</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Study Enrollment</title>
          <description>Low accrual. Only 4 subjects completed study in 2 month period. Study terminated.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study was terminated due to poor enrollment. Analyses were not conducted due to inconclusive nasal wash samples.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Lewis Radonovich</name_or_title>
      <organization>VA National Center for Occupational Health &amp; Infection Control</organization>
      <phone>352-376-1611 ext 4988</phone>
      <email>Lewis.radonovich@va.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01673425
org study id: IRB 604-2010
nct id: NCT01673425
lead sponsor: 
collaborator: 
has dmc: No
The Live-Attenuated Influenza Vaccine (LAIV), also known as FluMist, has been shown to be
      effective in children but less effective in adults. Our hypothesis is that this relative
      failure is due to adults having enough anti-flu IgA antibody in nasal secretions to
      neutralize the weakened vaccine virus.
This is a VA-based study to evaluate serum and nasal wash antibody responses to seasonal LAIV
      of healthy Veterans and VA employees between the ages of 20 and 49 years old.

      Specific Aims

        1. The primary aim of the study is to evaluate whether people with high mucosal IgA
           antibodies against flu have a lower immune response to the seasonal LAIV.

        2. The secondary objective is to determine whether the nasal wash viral neutralization data
           predicts LAIV immunization failures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: IgA Antibody Titers
time frame: Change from baseline in antibody titer at 6 weeks
measure: Serum Antibody Response to LAIV
time frame: Change from baseline in serum antibody response at 6 weeks
arm group label: Live Attenuated Influenza Vaccine
arm group type: Experimental
description: Single intervention study- all participants will receive LAIV instead of injectable flu vaccine.
intervention type: Drug
intervention name: Live Attenuated Influenza Vaccine
description: All participants will be given FluMist.
arm group label: Live Attenuated Influenza Vaccine
other name: FluMist
criteria: 
gender: All
minimum age: 20 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lewis J. Radonovich, MD
role: Principal Investigator
affiliation: National Center for Occupational Health and Infection Control
facility: 
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was terminated due to poor enrollment. Analyses were not conducted due to inconclusive nasal wash samples.
point of contact: 