<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/NCT03748524</url>
  </required_header>
  <id_info>
    <org_study_id>201808171</org_study_id>
    <nct_id>NCT03748524</nct_id>
  </id_info>
  <brief_title>Analysis of Antigen Specific B Cell Responses to Immunization With Influenza Virus Vaccine</brief_title>
  <official_title>Washington University (WU) 321: Analysis of Antigen Specific B Cell Responses to Immunization With Influenza Virus Vaccine: Fine Needle Aspiration (FNA) and Bone Marrow Aspiration (BMA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</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>
      Immunization with the inactivated influenza vaccine with blood samples collected at 7 visits&#xD;
      (baseline, day 7, 14, 28, 60, 90 and 180, fine needle aspiration (FNAs) from axillary lymph&#xD;
      nodes at baseline, days, 4, 14, 28, 60 and 180. BMA at baseline, days 28 and 180.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 29, 2018</start_date>
  <completion_date type="Anticipated">October 29, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</primary_completion_date>
  <phase>Early Phase 1</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>Determine the percentage of subjects achieving seroconversion</measure>
    <time_frame>0 and day 28</time_frame>
    <description>Change in serum hemagglutination-inhibition (HAI) antibody titers between day 0 to day 28</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine the frequency of vaccine-induced responses</measure>
    <time_frame>Day7</time_frame>
    <description>Frequency of vaccine-specific plasmablasts detected in blood at day 7 after vaccination</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Immunity, Cellular</condition>
  <arm_group>
    <arm_group_label>Single Influenza Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Influenza Vaccine,Quadrivalent</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Influenza Vaccine</intervention_name>
    <description>Influenza Vaccine,Quadrivalent SIngle vaccination all participants at day 0</description>
    <arm_group_label>Single Influenza Vaccine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to understand and give informed consent&#xD;
&#xD;
          2. Capable of attending all study visits according to the study schedule.&#xD;
&#xD;
          3. Males or females between the ages of 18 to 50 (inclusive).&#xD;
&#xD;
          4. Are in good health, as determined by medical history and targeted physical exam&#xD;
             related to this history.&#xD;
&#xD;
          5. Participants agree not to take any vaccines in the first 60 days after receipt of the&#xD;
             influenza vaccine&#xD;
&#xD;
          6. The following laboratory values obtained within 14 days prior to entry..&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥750 cells/mm3&#xD;
&#xD;
               -  Hemoglobin ≥11.0 g/dL for men and ≥10.0 g/dL for women&#xD;
&#xD;
               -  Platelet count ≥100,000/mm3&#xD;
&#xD;
               -  Creatinine clearance ≥60 mL/min estimated by the Cockcroft-Gault equation&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (SGPT) ≤5.0&#xD;
                  times upper limit of normal (ULN)&#xD;
&#xD;
          7. Willing to:&#xD;
&#xD;
               -  give FNA specimens for the study. (even if he/she are not willing to give bone&#xD;
                  marrow aspirates (for any reason), they can be enrolled)&#xD;
&#xD;
               -  give bone marrow aspirates, but we cannot locate axillary lymph nodes&#xD;
&#xD;
               -  give both FNA and BMA specimens&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. History influenza vaccination for the last three years.&#xD;
&#xD;
             2. Coagulopathy (primary or iatrogenic) which would contraindicate FNA&#xD;
&#xD;
             3. Any history of allergy to eggs, chicken or gelatin or to any previous influenza&#xD;
             vaccine&#xD;
&#xD;
             4. Have an acute illness within 72 hours before vaccination.&#xD;
&#xD;
             5. A history of a medical condition resulting in impaired immunity (such as HIV&#xD;
             infection, cancer, particularly leukemia, lymphoma, use of immunosuppressive or&#xD;
             antineoplastic drugs or X-ray treatment). Persons with previous skin cancers or cured&#xD;
             non-lymphatic tumors are not excluded from the study.&#xD;
&#xD;
             6. History of HIV infection, Hepatitis B or Hepatitis C infection&#xD;
&#xD;
             7. History of any chronic medical conditions that are considered progressive (ex,&#xD;
             diabetes, heart disease, lung disease, liver disease, kidney disease, gastrointestinal&#xD;
             diseases and uncontrolled hypertension).&#xD;
&#xD;
             8. History of excessive alcohol consumption, drug abuse, psychiatric conditions,&#xD;
             social conditions or occupational conditions that in the opinion of the investigator&#xD;
             would preclude compliance with the study.&#xD;
&#xD;
             9. Have taken oral or parenteral corticosteroids of any dose within 30 days before&#xD;
             study vaccination.&#xD;
&#xD;
             10. Have taken high-dose inhaled corticosteroids within 30 days before study&#xD;
             vaccination.&#xD;
&#xD;
             11. Autoimmune disorders; mild autoimmune disorders such as eczema is not exclusion&#xD;
             after assessment by the investigator.&#xD;
&#xD;
             12. Recipient of a blood products or immune globulin product within 42 days of the&#xD;
             vaccination visit.&#xD;
&#xD;
             13. Pregnant women and nursing mothers or women who are planning to become pregnant&#xD;
             for the study duration.&#xD;
&#xD;
             14. Have received any licensed live vaccine within 30 days or any licensed inactivated&#xD;
             vaccine within 14 days prior to study vaccination.&#xD;
&#xD;
             15. Have planned vaccination with any vaccine during first 60 days of study&#xD;
             participation.&#xD;
&#xD;
             16. Have received immunoglobulin or other blood products, with the exception of Rho D&#xD;
             immunoglobulin, within 90 days prior to study vaccination.&#xD;
&#xD;
             17. Have donated blood or blood products within 30 days before study vaccination, plan&#xD;
             to donate blood at any time during the duration of subject study participation, or&#xD;
             plan to donate blood within 30 days after the last blood draw.&#xD;
&#xD;
             18. Any condition in the opinion of the investigator that would interfere with the&#xD;
             proper conduct of the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ali Ellebedy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine Infectious Disease Clinical Research Unit</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>January 5, 2021</last_update_submitted>
  <last_update_submitted_qc>January 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza, B cells, Antibodies, Vaccination</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/NCT03748524
org study id: 201808171
nct id: NCT03748524
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Immunization with the inactivated influenza vaccine with blood samples collected at 7 visits
      (baseline, day 7, 14, 28, 60, 90 and 180, fine needle aspiration (FNAs) from axillary lymph
      nodes at baseline, days, 4, 14, 28, 60 and 180. BMA at baseline, days 28 and 180.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Determine the percentage of subjects achieving seroconversion
time frame: 0 and day 28
description: Change in serum hemagglutination-inhibition (HAI) antibody titers between day 0 to day 28
measure: Determine the frequency of vaccine-induced responses
time frame: Day7
description: Frequency of vaccine-specific plasmablasts detected in blood at day 7 after vaccination
arm group label: Single Influenza Vaccine
arm group type: Experimental
description: Single Influenza Vaccine,Quadrivalent
intervention type: Drug
intervention name: Influenza Vaccine
description: Influenza Vaccine,Quadrivalent SIngle vaccination all participants at day 0
arm group label: Single Influenza Vaccine
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ali Ellebedy, PhD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No