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

NCT ID: NCT03748524

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-29
• Study Completion Date: 2022-06-20

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.

Detailed Description

IM 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.

Conditions

Immunity, Cellular

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single Influenza Vaccine

Single Influenza Vaccine,Quadrivalent

Group Type: EXPERIMENTAL

Influenza Vaccine

Intervention Type: DRUG

Influenza Vaccine,Quadrivalent SIngle vaccination all participants at day 0

Interventions

Influenza Vaccine

Influenza Vaccine,Quadrivalent SIngle vaccination all participants at day 0

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Ellebedy, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine Infectious Disease Clinical Research Unit

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201808171

Identifier Type: -

Identifier Source: org_study_id