<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/NCT03028987</url>
  </required_header>
  <id_info>
    <org_study_id>SU-31434-2014-2019</org_study_id>
    <secondary_id>2U19AI057229-11</secondary_id>
    <nct_id>NCT03028987</nct_id>
  </id_info>
  <brief_title>Adaptive Immune Responses and Repertoire in Influenza Vaccination and Infection (SLVP031)</brief_title>
  <official_title>Project 1. The Role of CD4+ Memory Phenotype, Memory, and Effector T-Cells in Vaccination and Infection - Influenza-specific DR1501+ and DR0701+ T-cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is provide a better understanding of the adaptive immune response&#xD;
      to the licensed flu vaccines. The investigators hope the information learned from this study&#xD;
      will help identify and describe important factors of influenza immunity especially of or&#xD;
      specific proteins associated with the T-cell immune response.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a study of up to 20 healthy monozygotic (MZ) twins, 18-49 years old, that are&#xD;
      participants from past Stanford-LPCH Vaccine Program trials and who have been identified as&#xD;
      human leukocyte antigen (HLA) DR1501+ or DR0701+ by lab assay results. Volunteers will be&#xD;
      contacted to assess interest in participating in this study. Both twins in the pair must be&#xD;
      willing to participate in the study. All participants will be randomized within the twin pair&#xD;
      to receive either the seasonal live, attenuated influenza vaccine (LAIV) or the seasonal&#xD;
      quadrivalent inactivated influenza vaccine (IIV4). Immunization will be at Day 0, blood&#xD;
      samples for immunogenicity assays will be collected prior to immunization and at Days 7 (6-8)&#xD;
      and 28 (24-32).&#xD;
&#xD;
      This study was halted due to the Advisory Committee on Immunization Practices decision not to&#xD;
      recommend use of LAIV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    LAIV was no longer recommended by ACIP&#xD;
  </why_stopped>
  <start_date type="Actual">November 19, 2014</start_date>
  <completion_date type="Actual">November 18, 2015</completion_date>
  <primary_completion_date type="Actual">November 18, 2015</primary_completion_date>
  <phase>Phase 4</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Received Influenza Vaccine</measure>
    <time_frame>Day 0</time_frame>
    <description>Number of individual twins who received either LAIV or IIV4 as dictated by their group assignment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Related Adverse Events</measure>
    <time_frame>Day 0 to 28 post-immunization</time_frame>
    <description>Number of individual twins who experienced related adverse events through the course of the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>LAIV randomized</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Volunteers are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IIV4 randomized</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Volunteers are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone®</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone®</intervention_name>
    <description>Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine)</description>
    <arm_group_label>IIV4 randomized</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FluMist®</intervention_name>
    <description>FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine)</description>
    <arm_group_label>LAIV randomized</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Otherwise healthy 18-49 years old identical (MZ) twins identified as DR1501+ or&#xD;
             DR0701+ by lab assay results. Both twins in the pair must be willing to participate in&#xD;
             the study.&#xD;
&#xD;
          2. Willing to complete the informed consent process&#xD;
&#xD;
          3. Availability for follow-up for the planned duration of the study&#xD;
&#xD;
          4. Acceptable medical history by review of inclusion/exclusion criteria and vital signs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior off-study vaccination with the current year's seasonal influenza vaccine.&#xD;
&#xD;
          2. Allergy to egg or egg products or to vaccine components including gentamicin, gelatin,&#xD;
             arginine or MSG&#xD;
&#xD;
          3. Life-threatening reactions to previous influenza vaccinations&#xD;
&#xD;
          4. Asthma (a contraindication for receipt of LAIV4)&#xD;
&#xD;
          5. Active systemic or serious concurrent illness, including febrile illness on the day of&#xD;
             vaccination&#xD;
&#xD;
          6. History of immunodeficiency (including HIV infection)&#xD;
&#xD;
          7. Known or suspected impairment of immunologic function, including, but not limited to,&#xD;
             clinically significant liver disease, diabetes mellitus treated with insulin, moderate&#xD;
             to severe renal disease, or any other chronic disorder which, in the opinion of the&#xD;
             investigator, might jeopardize volunteer safety or compliance with the protocol.&#xD;
&#xD;
          8. Blood pressure &gt;150 systolic or &gt;95 diastolic at first study visit and the day of&#xD;
             vaccination.&#xD;
&#xD;
          9. Hospitalization in the past year for congestive heart failure or emphysema.&#xD;
&#xD;
         10. Chronic Hepatitis B or C.&#xD;
&#xD;
         11. Recent or current use of immunosuppressive medication, including systemic&#xD;
             glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in&#xD;
             all groups; inhaled steroid use is not permissible)&#xD;
&#xD;
         12. Participants who care for severely immunosuppressed persons that require a protective&#xD;
             environment should not receive LAIV, or should avoid contact with such persons for 7&#xD;
             days after receipt, given the theoretical risk for transmission of the live attenuated&#xD;
             vaccine virus to close contacts. [If yes, may be ineligible]&#xD;
&#xD;
         13. Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors&#xD;
             such as breast cancer or prostate cancer with recurrence in the past year, and any&#xD;
             hematologic cancer such as leukemia).&#xD;
&#xD;
         14. Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive&#xD;
             medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion&#xD;
             of the investigator, might jeopardize volunteer safety or compliance with the&#xD;
             protocol.&#xD;
&#xD;
         15. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular&#xD;
             medical follow up or hospitalization during the preceding year&#xD;
&#xD;
         16. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet&#xD;
             agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox must be&#xD;
             reviewed by investigator to determine if this would affect the volunteer's safety.&#xD;
&#xD;
         17. Has taken an influenza antiviral medication within 48 hours prior to study vaccination&#xD;
             [If yes, may not eligible if unable to schedule at an appropriate interval].&#xD;
&#xD;
         18. Receipt of blood or blood products within the past 6 months or planned used during the&#xD;
             study.&#xD;
&#xD;
         19. Medical or psychiatric condition or occupational responsibilities that preclude&#xD;
             participant compliance with the protocol&#xD;
&#xD;
         20. Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned&#xD;
             vaccinations prior to completion of last study visit ( ~ 28 days after study&#xD;
             vaccination)&#xD;
&#xD;
         21. Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned&#xD;
             vaccination prior to completion of last study visit (~ 28 days after study&#xD;
             vaccination)&#xD;
&#xD;
         22. Need for allergy immunization (that cannot be postponed) during the study period.&#xD;
&#xD;
         23. History of Guillain-Barré syndrome&#xD;
&#xD;
         24. Pregnant or lactating woman&#xD;
&#xD;
         25. Use of investigational agents within 30 days prior to enrollment or planned use during&#xD;
             the study.&#xD;
&#xD;
         26. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or&#xD;
             planned donation prior to completion of the last visit.&#xD;
&#xD;
         27. Any condition which, in the opinion of the investigator, might interfere with&#xD;
             volunteer safety, study objectives or the ability of the participant to understand or&#xD;
             comply with the study protocol.&#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>Cornelia Dekker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark Davis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>K. Christopher Garcia, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <results_first_submitted>July 11, 2017</results_first_submitted>
  <results_first_submitted_qc>August 10, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">September 12, 2017</results_first_posted>
  <last_update_submitted>August 10, 2017</last_update_submitted>
  <last_update_submitted_qc>August 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Cornelia L. Dekker</investigator_full_name>
    <investigator_title>Professor, Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Quadrivalent, inactivated influenza vaccine</keyword>
  <keyword>Quadrivalent, live, attenuated influenza vaccine</keyword>
  <keyword>Identical twin adults</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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Volunteers are past participants who are identical twins and who have been identified as HLA DR1501+ or DR0701+ by lab assay results.</recruitment_details>
      <pre_assignment_details>All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® .</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>LAIV Randomized</title>
          <description>Individual twins in this group received FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine).</description>
        </group>
        <group group_id="P2">
          <title>IIV4 Randomized</title>
          <description>Individual twins in this group received Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine).</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 group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>LAIV Randomized</title>
          <description>Individual twins are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® .&#xD;
FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine)</description>
        </group>
        <group group_id="B2">
          <title>IIV4 Randomized</title>
          <description>Individual twins are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone®&#xD;
Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="10"/>
          </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46" spread="9.79"/>
                    <measurement group_id="B2" value="46" spread="9.79"/>
                    <measurement group_id="B3" value="46" spread="9.23"/>
                  </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="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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 group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Received Influenza Vaccine</title>
        <description>Number of individual twins who received either LAIV or IIV4 as dictated by their group assignment</description>
        <time_frame>Day 0</time_frame>
        <group_list>
          <group group_id="O1">
            <title>LAIV Randomized</title>
            <description>Individual twins in this group received FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine).</description>
          </group>
          <group group_id="O2">
            <title>IIV4 Randomized</title>
            <description>Individual twins in this group received Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Influenza Vaccine</title>
          <description>Number of individual twins who received either LAIV or IIV4 as dictated by their group assignment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Related Adverse Events</title>
        <description>Number of individual twins who experienced related adverse events through the course of the study.</description>
        <time_frame>Day 0 to 28 post-immunization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>LAIV Randomized</title>
            <description>Individual twins in this group received FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine).</description>
          </group>
          <group group_id="O2">
            <title>IIV4 Randomized</title>
            <description>Individual twins in this group received Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Related Adverse Events</title>
          <description>Number of individual twins who experienced related adverse events through the course of the study.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected from Day 0 to 28 days post-immunization.</time_frame>
      <desc>Adverse Events will be collected from Day 0 to 28 days post-immunization.</desc>
      <group_list>
        <group group_id="E1">
          <title>LAIV Randomized</title>
          <description>Individual twins in this group received FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine).</description>
        </group>
        <group group_id="E2">
          <title>IIV4 Randomized</title>
          <description>Individual twins in this group received Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" 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"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>
    <point_of_contact>
      <name_or_title>Cornelia Dekker, MD</name_or_title>
      <organization>Stanford University School of Medicine, Dept. of Pediatrics</organization>
      <phone>6507244437</phone>
      <email>cdekker@stanford.edu</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/NCT03028987
org study id: SU-31434-2014-2019
secondary id: 2U19AI057229-11
nct id: NCT03028987
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is provide a better understanding of the adaptive immune response
      to the licensed flu vaccines. The investigators hope the information learned from this study
      will help identify and describe important factors of influenza immunity especially of or
      specific proteins associated with the T-cell immune response.
This is a study of up to 20 healthy monozygotic (MZ) twins, 18-49 years old, that are
      participants from past Stanford-LPCH Vaccine Program trials and who have been identified as
      human leukocyte antigen (HLA) DR1501+ or DR0701+ by lab assay results. Volunteers will be
      contacted to assess interest in participating in this study. Both twins in the pair must be
      willing to participate in the study. All participants will be randomized within the twin pair
      to receive either the seasonal live, attenuated influenza vaccine (LAIV) or the seasonal
      quadrivalent inactivated influenza vaccine (IIV4). Immunization will be at Day 0, blood
      samples for immunogenicity assays will be collected prior to immunization and at Days 7 (6-8)
      and 28 (24-32).

      This study was halted due to the Advisory Committee on Immunization Practices decision not to
      recommend use of LAIV.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Number of Participants Who Received Influenza Vaccine
time frame: Day 0
description: Number of individual twins who received either LAIV or IIV4 as dictated by their group assignment
measure: Number of Participants With Related Adverse Events
time frame: Day 0 to 28 post-immunization
description: Number of individual twins who experienced related adverse events through the course of the study.
arm group label: LAIV randomized
arm group type: Other
description: Volunteers are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® .
arm group label: IIV4 randomized
arm group type: Other
description: Volunteers are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone®
intervention type: Biological
intervention name: Fluzone®
description: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine)
arm group label: IIV4 randomized
intervention type: Biological
intervention name: FluMist®
description: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine)
arm group label: LAIV randomized
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cornelia Dekker, MD
role: Principal Investigator
affiliation: Stanford University
last name: Mark Davis, PhD
role: Principal Investigator
affiliation: Stanford University
last name: K. Christopher Garcia, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Cornelia L. Dekker
investigator title: Professor, Pediatrics
mesh term: Influenza, Human
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 