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



Status:Recruiting
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 50
Updated:11/23/2018
Start Date:October 29, 2018
End Date:October 29, 2020
Contact:Ali Ellebedy, PhD
Email:ellebedy@wustl.edu
Phone:314 747 0691

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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)

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.


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.
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