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Analysis of Antigen Specific B Cell Responses to Immunization With Influenza Virus Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748524
Recruitment Status : Active, not recruiting
First Posted : November 21, 2018
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Immunity, Cellular Drug: Influenza Vaccine Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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)
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : October 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Single Influenza Vaccine
Single Influenza Vaccine,Quadrivalent
Drug: Influenza Vaccine
Influenza Vaccine,Quadrivalent SIngle vaccination all participants at day 0




Primary Outcome Measures :
  1. Determine the percentage of subjects achieving seroconversion [ Time Frame: 0 and day 28 ]
    Change in serum hemagglutination-inhibition (HAI) antibody titers between day 0 to day 28


Secondary Outcome Measures :
  1. Determine the frequency of vaccine-induced responses [ Time Frame: Day7 ]
    Frequency of vaccine-specific plasmablasts detected in blood at day 7 after vaccination



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Able to understand and give informed consent
  2. Capable of attending all study visits according to the study schedule.
  3. Males or females between the ages of 18 to 50 (inclusive).
  4. Are in good health, as determined by medical history and targeted physical exam related to this history.
  5. Participants agree not to take any vaccines in the first 60 days after receipt of the influenza vaccine
  6. The following laboratory values obtained within 14 days prior to entry..

    • Absolute neutrophil count (ANC) ≥750 cells/mm3
    • Hemoglobin ≥11.0 g/dL for men and ≥10.0 g/dL for women
    • Platelet count ≥100,000/mm3
    • Creatinine clearance ≥60 mL/min estimated by the Cockcroft-Gault equation
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (SGPT) ≤5.0 times upper limit of normal (ULN)
  7. Willing to:

    • give FNA specimens for the study. (even if he/she are not willing to give bone marrow aspirates (for any reason), they can be enrolled)
    • give bone marrow aspirates, but we cannot locate axillary lymph nodes
    • give both FNA and BMA specimens

Exclusion Criteria:

  • 1. History influenza vaccination for the last three years.

    2. Coagulopathy (primary or iatrogenic) which would contraindicate FNA

    3. Any history of allergy to eggs, chicken or gelatin or to any previous influenza vaccine

    4. Have an acute illness within 72 hours before vaccination.

    5. A history of a medical condition resulting in impaired immunity (such as HIV infection, cancer, particularly leukemia, lymphoma, use of immunosuppressive or antineoplastic drugs or X-ray treatment). Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study.

    6. History of HIV infection, Hepatitis B or Hepatitis C infection

    7. History of any chronic medical conditions that are considered progressive (ex, diabetes, heart disease, lung disease, liver disease, kidney disease, gastrointestinal diseases and uncontrolled hypertension).

    8. History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the study.

    9. Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination.

    10. Have taken high-dose inhaled corticosteroids within 30 days before study vaccination.

    11. Autoimmune disorders; mild autoimmune disorders such as eczema is not exclusion after assessment by the investigator.

    12. Recipient of a blood products or immune globulin product within 42 days of the vaccination visit.

    13. Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.

    14. Have received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to study vaccination.

    15. Have planned vaccination with any vaccine during first 60 days of study participation.

    16. Have received immunoglobulin or other blood products, with the exception of Rho D immunoglobulin, within 90 days prior to study vaccination.

    17. Have donated blood or blood products within 30 days before study vaccination, plan to donate blood at any time during the duration of subject study participation, or plan to donate blood within 30 days after the last blood draw.

    18. Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748524


Locations
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United States, Missouri
Washington University School of Medicine Infectious Disease Clinical Research Unit
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Ali Ellebedy, PhD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03748524    
Other Study ID Numbers: 201808171
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
Influenza, B cells, Antibodies, Vaccination
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases