<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/NCT02987374</url>
  </required_header>
  <id_info>
    <org_study_id>SU-24167</org_study_id>
    <secondary_id>U19AI057229-06</secondary_id>
    <nct_id>NCT02987374</nct_id>
  </id_info>
  <brief_title>Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization</brief_title>
  <acronym>SLVP023</acronym>
  <official_title>Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization</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 is to investigate B-cell response to the trivalent Influenza Vaccine (TIV) in&#xD;
      healthy young adults by vaccinating participants and obtaining blood samples at designated&#xD;
      time points before and after vaccination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an exploratory study using a strategy that has not been previously employed to&#xD;
      investigate B-cell responses. Investigators will collect blood samples from the volunteers at&#xD;
      a higher frequency than in the two previous flu seasons to better define the dynamic response&#xD;
      to vaccination. The objective is to compare the Ig gene repertoire before and after&#xD;
      vaccination by deep sequencing PBMC and proteomic analysis of antibody CDR3 regions at 10&#xD;
      different time points before and after immunization.&#xD;
&#xD;
      This is a Phase IV study of healthy adults who are given standard TIV off-season. There are&#xD;
      no exclusions for gender, ethnicity or race. Following confirmation of written informed&#xD;
      consent, baseline blood samples will be drawn from all study participants at Day -5, Day -3&#xD;
      and Day 0 prior to immunization, and at Days 1, 4, 7, 9, 11, 28 and 180 post-immunization.&#xD;
      Volunteers will be vaccine-naïve for the 2010-2011 and 2011-2012 seasonal influenza vaccines.&#xD;
      All participants will receive a single dose of the current seasonal influenza vaccine by&#xD;
      intramuscular (IM) injection at Day 0.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 4</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>Number of Participants Who Received Influenza Vaccine</measure>
    <time_frame>Day 0 to 180 post-immunization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Related Adverse Events</measure>
    <time_frame>Day 0 to 180 post-immunization</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Proteomic Analysis of Antibody CDR3 Regions at 10 Different Time Points Before and After Immunization.</measure>
    <time_frame>Day -5 to 180 post-immunization</time_frame>
    <description>Proteomic analysis: Identification, production, and characterization of Influenza A specific antibodies and their CDRH3 amino-acid sequences.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>2011-2012 Fluzone IIV3 (IM)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Seasonal trivalent flu vaccine: NDC No 49281-011-50</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>2011-2012 Fluzone IIV3 (IM)</intervention_name>
    <description>2011-2012 Fluzone IIV3 vaccine delivered intramuscularly (IM)</description>
    <arm_group_label>2011-2012 Fluzone IIV3 (IM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Otherwise healthy, 18-30 year old young adult.&#xD;
&#xD;
          2. Availability for follow-up for the planned duration of the study at least 180 days&#xD;
             after immunization.&#xD;
&#xD;
          3. Acceptable medical history by medical history and vital signs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior vaccination with 2010-2011 seasonal TIV or LAIV.&#xD;
&#xD;
          2. Prior off-study vaccination with the current 2011-2012 seasonal TIV or LAIV&#xD;
&#xD;
          3. Weight less than 110 pounds.&#xD;
&#xD;
          4. Allergy to egg or egg products, or to vaccine components, including gelatin or&#xD;
             thimerosal (thimerosal in TIV multidose vials only).&#xD;
&#xD;
          5. Life-threatening reactions to previous influenza vaccinations&#xD;
&#xD;
          6. Active systemic or serious concurrent illness, including febrile illness on the day of&#xD;
             vaccination&#xD;
&#xD;
          7. History of immunodeficiency (including HIV infection)&#xD;
&#xD;
          8. 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;
          9. Blood pressure &gt;150 systolic or &gt;95 diastolic at first study visit&#xD;
&#xD;
         10. Hospitalization in the past year for congestive heart failure or emphysema.&#xD;
&#xD;
         11. Chronic Hepatitis B or C.&#xD;
&#xD;
         12. Recent or current use of immunosuppressive medication, including systemic&#xD;
             glucocorticoids. Corticosteroid nasal sprays and topical steroids are permissible.&#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. Receipt of blood or blood products within the past 6 months.&#xD;
&#xD;
         18. Medical or psychiatric condition or occupational responsibilities that preclude&#xD;
             participant compliance with the protocol&#xD;
&#xD;
         19. Receipt of inactivated vaccine 14 days prior to study enrollment, planned vaccinations&#xD;
             prior to completion of Visit 09 (Day 28 after study vaccination), or planned&#xD;
             vaccination 14 days prior to Visit 10 (6 months after study vaccination).&#xD;
&#xD;
         20. Receipt of live, attenuated vaccine 60 days prior to study enrollment, planned&#xD;
             vaccination prior to completion of Visit 09 (Day 28 after study vaccination), or&#xD;
             planned vaccination 14 days prior to Visit 10 (6 months after study vaccination).&#xD;
&#xD;
         21. History of Guillain-Barré Syndrome&#xD;
&#xD;
         22. Pregnant or lactating woman&#xD;
&#xD;
         23. Use of investigational agents within 30 days prior to study enrollment or planned use&#xD;
             during the study period.&#xD;
&#xD;
         24. Donation of the equivalent of a unit of blood within 6 weeks prior to study&#xD;
             enrollment, or during the first 5 weeks of study participation.&#xD;
&#xD;
         25. A member of the study team or their family member, to include investigators, research&#xD;
             laboratory staff, clinical research staff.&#xD;
&#xD;
         26. 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>30 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>Stephen Quake, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <reference>
    <citation>Lee J, Boutz DR, Chromikova V, Joyce MG, Vollmers C, Leung K, Horton AP, DeKosky BJ, Lee CH, Lavinder JJ, Murrin EM, Chrysostomou C, Hoi KH, Tsybovsky Y, Thomas PV, Druz A, Zhang B, Zhang Y, Wang L, Kong WP, Park D, Popova LI, Dekker CL, Davis MM, Carter CE, Ross TM, Ellington AD, Wilson PC, Marcotte EM, Mascola JR, Ippolito GC, Krammer F, Quake SR, Kwong PD, Georgiou G. Molecular-level analysis of the serum antibody repertoire in young adults before and after seasonal influenza vaccination. Nat Med. 2016 Dec;22(12):1456-1464. doi: 10.1038/nm.4224. Epub 2016 Nov 7.</citation>
    <PMID>27820605</PMID>
  </reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <results_first_submitted>December 15, 2016</results_first_submitted>
  <results_first_submitted_qc>December 16, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 26, 2016</results_first_posted>
  <last_update_submitted>April 3, 2017</last_update_submitted>
  <last_update_submitted_qc>April 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 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>Influenza Vaccine</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>Yes</sharing_ipd>
    <ipd_description>The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique ID code and the volunteer identity (except for age) will not be disclosed.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>During spring and early summer (prior to June 30) of 2012, 11 participants were consented to participate. One participant was found to be ineligible and was therefore withdrawn prior to any interventions.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>2011-2012 Fluzone IIV3 (IM)</title>
          <description>2011-2012 Fluzone IIV3 NDC No 49281-011-50&#xD;
2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants between the ages of 18-30</population>
      <group_list>
        <group group_id="B1">
          <title>2011-2012 Fluzone IIV3 (IM)</title>
          <description>2011-2012 Fluzone IIV3 NDC No 49281-011-50&#xD;
2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Between 18 and 30 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </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="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" 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>
        <time_frame>Day 0 to 180 post-immunization</time_frame>
        <population>10 participants received the 2011-2012 Fluzone IIV3 vaccine</population>
        <group_list>
          <group group_id="O1">
            <title>2011-2012 Fluzone IIV3 (IM)</title>
            <description>2011-2012 Fluzone IIV3 NDC No 49281-011-50&#xD;
2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Influenza Vaccine</title>
          <population>10 participants received the 2011-2012 Fluzone IIV3 vaccine</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Related Adverse Events</title>
        <time_frame>Day 0 to 180 post-immunization</time_frame>
        <population>Number of participants with related adverse events up to 180 days post immunization</population>
        <group_list>
          <group group_id="O1">
            <title>2011-2012 Fluzone IIV3 (IM)</title>
            <description>2011-2012 Fluzone IIV3 NDC No 49281-011-50&#xD;
2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Related Adverse Events</title>
          <population>Number of participants with related adverse events up to 180 days post immunization</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proteomic Analysis of Antibody CDR3 Regions at 10 Different Time Points Before and After Immunization.</title>
        <description>Proteomic analysis: Identification, production, and characterization of Influenza A specific antibodies and their CDRH3 amino-acid sequences.</description>
        <time_frame>Day -5 to 180 post-immunization</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>180 days post immunization</time_frame>
      <group_list>
        <group group_id="E1">
          <title>2011-2012 Fluzone IIV3 (IM)</title>
          <description>2011-2012 Fluzone IIV3 NDC No 49281-011-50&#xD;
2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)</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="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Low Back Pain</sub_title>
                <description>Pain in lumbosacral area</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Abrasion LT upper leg</sub_title>
                <description>Bike Accident</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </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>Dr Cornelia Dekker</name_or_title>
      <organization>Stanford University School of Medicine, Dept. of Pediatrics</organization>
      <phone>650-724-4437</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/NCT02987374
org study id: SU-24167
secondary id: U19AI057229-06
nct id: NCT02987374
lead sponsor: 
collaborator: 
has dmc: No
The purpose is to investigate B-cell response to the trivalent Influenza Vaccine (TIV) in
      healthy young adults by vaccinating participants and obtaining blood samples at designated
      time points before and after vaccination.
This is an exploratory study using a strategy that has not been previously employed to
      investigate B-cell responses. Investigators will collect blood samples from the volunteers at
      a higher frequency than in the two previous flu seasons to better define the dynamic response
      to vaccination. The objective is to compare the Ig gene repertoire before and after
      vaccination by deep sequencing PBMC and proteomic analysis of antibody CDR3 regions at 10
      different time points before and after immunization.

      This is a Phase IV study of healthy adults who are given standard TIV off-season. There are
      no exclusions for gender, ethnicity or race. Following confirmation of written informed
      consent, baseline blood samples will be drawn from all study participants at Day -5, Day -3
      and Day 0 prior to immunization, and at Days 1, 4, 7, 9, 11, 28 and 180 post-immunization.
      Volunteers will be vaccine-naïve for the 2010-2011 and 2011-2012 seasonal influenza vaccines.
      All participants will receive a single dose of the current seasonal influenza vaccine by
      intramuscular (IM) injection at Day 0.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Number of Participants Who Received Influenza Vaccine
time frame: Day 0 to 180 post-immunization
measure: Number of Participants With Related Adverse Events
time frame: Day 0 to 180 post-immunization
measure: Proteomic Analysis of Antibody CDR3 Regions at 10 Different Time Points Before and After Immunization.
time frame: Day -5 to 180 post-immunization
description: Proteomic analysis: Identification, production, and characterization of Influenza A specific antibodies and their CDRH3 amino-acid sequences.
arm group label: 2011-2012 Fluzone IIV3 (IM)
arm group type: Other
description: Seasonal trivalent flu vaccine: NDC No 49281-011-50
intervention type: Biological
intervention name: 2011-2012 Fluzone IIV3 (IM)
description: 2011-2012 Fluzone IIV3 vaccine delivered intramuscularly (IM)
arm group label: 2011-2012 Fluzone IIV3 (IM)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cornelia Dekker, MD
role: Principal Investigator
affiliation: Stanford University
last name: Stephen Quake, PhD
role: Principal Investigator
affiliation: Stanford University
citation: Lee J, Boutz DR, Chromikova V, Joyce MG, Vollmers C, Leung K, Horton AP, DeKosky BJ, Lee CH, Lavinder JJ, Murrin EM, Chrysostomou C, Hoi KH, Tsybovsky Y, Thomas PV, Druz A, Zhang B, Zhang Y, Wang L, Kong WP, Park D, Popova LI, Dekker CL, Davis MM, Carter CE, Ross TM, Ellington AD, Wilson PC, Marcotte EM, Mascola JR, Ippolito GC, Krammer F, Quake SR, Kwong PD, Georgiou G. Molecular-level analysis of the serum antibody repertoire in young adults before and after seasonal influenza vaccination. Nat Med. 2016 Dec;22(12):1456-1464. doi: 10.1038/nm.4224. Epub 2016 Nov 7.
PMID: 27820605
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: Yes
ipd description: The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique ID code and the volunteer identity (except for age) will not be disclosed.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 