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CompletedNCT03748524Updated Jan 13, 2025

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

An Early Phase 1 interventional study of Influenza Vaccine in Immunity, Cellular, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-13.

Sponsored by Washington University School of Medicine · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Sep 2021, 5 years ago, and no results have been posted to the registry.
Phase
Early Phase 1
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Immunity, Cellular

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Keywords

  • Influenza, B cells, Antibodies, Vaccination
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 11 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

    1. History influenza vaccination for the last three years.

      1. Coagulopathy (primary or iatrogenic) which would contraindicate FNA
      1. Any history of allergy to eggs, chicken or gelatin or to any previous influenza vaccine
      1. Have an acute illness within 72 hours before vaccination.
      1. 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.
      1. History of HIV infection, Hepatitis B or Hepatitis C infection
      1. 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).
      1. 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.
      1. Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination.
      1. Have taken high-dose inhaled corticosteroids within 30 days before study vaccination.
      1. Autoimmune disorders; mild autoimmune disorders such as eczema is not exclusion after assessment by the investigator.
      1. Recipient of a blood products or immune globulin product within 42 days of the vaccination visit.
      1. Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.
      1. Have received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to study vaccination.
      1. Have planned vaccination with any vaccine during first 60 days of study participation.
      1. Have received immunoglobulin or other blood products, with the exception of Rho D immunoglobulin, within 90 days prior to study vaccination.
      1. 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.
      1. Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Single Influenza Vaccine

    Single Influenza Vaccine,Quadrivalent

    Drug: Influenza Vaccine

Interventions

  • DrugInfluenza Vaccine

    Influenza Vaccine,Quadrivalent SIngle vaccination all participants at day 0

06

What researchers measure

Primary outcomes

  1. Determine the percentage of subjects achieving seroconversion

    Change in serum hemagglutination-inhibition (HAI) antibody titers between day 0 to day 28

    Time frame: 0 and day 28

Secondary outcomes

  1. Determine the frequency of vaccine-induced responses

    Frequency of vaccine-specific plasmablasts detected in blood at day 7 after vaccination

    Time frame: Day7

07

Study locations

1 site
  • Washington University School of Medicine Infectious Disease Clinical Research Unit
    Saint Louis, Missouri 63110, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03748524
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Nov 21, 2018
Start date
Oct 29, 2018
Primary completion
Sep 30, 2021
Completion
Jun 20, 2022
Last update
Jan 13, 2025

Study contacts

Ali Ellebedy, PhD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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