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Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood (FLU-LN)

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ClinicalTrials.gov Identifier: NCT03898973
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : May 4, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Philip Grant, Stanford University

Study Description
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Brief Summary:
This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to determine how immune memory develops at the actual site of exposure, and how immunization may alter this process.

Condition or disease Intervention/treatment Phase
Influenza Biological: Quadrivalent inactivated influenza vaccine (IIV) Phase 4

Detailed Description:

This is a Phase IV study of licensed influenza vaccines with up to 50 volunteers, 20-75 years of age.

Each volunteer will participate for approximately 1 week including enrollment, vaccination, and completion of sample collection.

The study has a total of 3 visits.

Study Procedures:

Screening Visit: Procedures during this visit are: Informed consent process, assess eligibility collect relevant clinical data and obtain 10 mL of blood to ensure the FNA will be safe (acceptable CBC and PT/PTT).

Visit 1: Vaccination Visit:

Eligible subjects will return and have a 20 mL blood sample. Participants will receive the inactivated flu vaccine into the right anterior quadriceps. Volunteers will be monitored for at least 15 minutes after study vaccination.

Visit 2: FNA Procedure: Seven days after vaccination the participant will return for another collection of 20 ml of blood and a fine needle aspiration of a right inguinal lymph node under ultrasound guidance by a trained pathologist.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
Study Phase
Participants will be given the current year's a quadrivalent inactivated influenza vaccine (IIV)
 Biological: Quadrivalent inactivated influenza vaccine (IIV)
Intramuscular Injection. Participants will receive the inactivated flu vaccine into anterior quadriceps.
Other Name: Fluzone Quadrivalent


Outcome Measures
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Primary Outcome Measures :
  1. HAI titer [ Time Frame: Day 7 after vaccination ]
    This measures response to influenza vaccine


Eligibility Criteria
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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:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 20-75-year-old male and female patients
  2. Body mass index (BMI) 20-35 kg/m2
  3. Acceptable laboratory values: Absolute neutrophil count (ANC) > 750 cells/mm3; Hemoglobin >10 g/dL; Platelet count >75,000/mm3; Partial thromboplastin time (PTT) >1.2x ULN; Prothrombin time (PT) >1.2x ULN
  4. Willing and able to complete the informed consent process
  5. Availability for follow-up for the planned duration of the study
  6. Acceptable medical history by review of inclusion/exclusion criteria

Exclusion Criteria:

  1. Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
  2. Life-threatening reactions to previous influenza vaccinations
  3. Allergy to egg or egg products or to vaccine components
  4. Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
  5. History of immunodeficiency (including HIV infection)
  6. Known or suspected impairment of immunologic function; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease
  7. Chronic Hepatitis B or C.
  8. Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
  9. Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
  10. Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator might jeopardize volunteer safety or compliance with the protocol.
  11. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
  12. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg per day), Plavix, or Aggrenox will be reviewed by investigators to determine if study participation would affect the volunteer's safety or compliance with the protocol.
  13. Receipt of blood or blood products within the past 6 months or planned used during the study.
  14. A medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
  15. Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned vaccinations prior to completion of last annual study visit (~ 28 days after study vaccination)
  16. Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned vaccination prior to completion of last study visit (~ 28 days after study enrollment)
  17. Need for allergy immunization (that cannot be postponed) until after the last study visit.
  18. History of Guillain-Barre# syndrome
  19. Use of investigational agents within 30 days prior to enrollment or planned use during the study.
  20. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or donation of platelets within 2 weeks of enrollment or planned donation prior to completion of the last visit.
  21. Pregnancy
  22. Any condition which, in the opinion of the investigator, might interfere with volunteer safety,
Contacts and Locations
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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): NCT03898973


Contacts
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Contact: Philip Grant 6507239443 pmgrant@stanford.edu

Locations
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United States, California
Stanford University Medical Center, Lane building L134 Recruiting
Stanford, California, United States, 94305
Contact: Philip M Grant, MD    650-723-9443    pmgrant@stanford.edu   
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
More Information
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Responsible Party: Philip Grant, Assistant Professor of Medicine (Infectious Diseases), Stanford University
ClinicalTrials.gov Identifier: NCT03898973    
Other Study ID Numbers: 50328
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: May 4, 2022
Last Verified: May 2022
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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases