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

Primary Purpose

Immunity, Cellular

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Influenza Vaccine
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Immunity, Cellular focused on measuring Influenza, B cells, Antibodies, Vaccination

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Washington University School of Medicine Infectious Disease Clinical Research Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Influenza Vaccine

Arm Description

Single Influenza Vaccine,Quadrivalent

Outcomes

Primary Outcome Measures

Determine the percentage of subjects achieving seroconversion
Change in serum hemagglutination-inhibition (HAI) antibody titers between day 0 to day 28

Secondary Outcome Measures

Determine the frequency of vaccine-induced responses
Frequency of vaccine-specific plasmablasts detected in blood at day 7 after vaccination

Full Information

First Posted
November 15, 2018
Last Updated
January 5, 2021
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03748524
Brief Title
Analysis of Antigen Specific B Cell Responses to Immunization With Influenza Virus Vaccine
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
October 29, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunity, Cellular
Keywords
Influenza, B cells, Antibodies, Vaccination

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Influenza Vaccine
Arm Type
Experimental
Arm Description
Single Influenza Vaccine,Quadrivalent
Intervention Type
Drug
Intervention Name(s)
Influenza Vaccine
Intervention Description
Influenza Vaccine,Quadrivalent SIngle vaccination all participants at day 0
Primary Outcome Measure Information:
Title
Determine the percentage of subjects achieving seroconversion
Description
Change in serum hemagglutination-inhibition (HAI) antibody titers between day 0 to day 28
Time Frame
0 and day 28
Secondary Outcome Measure Information:
Title
Determine the frequency of vaccine-induced responses
Description
Frequency of vaccine-specific plasmablasts detected in blood at day 7 after vaccination
Time Frame
Day7

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to understand and give informed consent Capable of attending all study visits according to the study schedule. Males or females between the ages of 18 to 50 (inclusive). Are in good health, as determined by medical history and targeted physical exam related to this history. Participants agree not to take any vaccines in the first 60 days after receipt of the influenza vaccine 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) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ellebedy, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine Infectious Disease Clinical Research Unit
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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