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

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.

Study Overview

• Status: Withdrawn
• Conditions: Influenza
• Intervention / Treatment: Biological: Quadrivalent inactivated influenza vaccine (IIV)

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Philip Grant; Phone Number: 6507239443; Email: pmgrant@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University Medical Center, Lane building L134

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Fluzone Quadrivalent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HAI titer	This measures response to influenza vaccine	Day 7 after vaccination

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2019
• Primary Completion (Actual): November 17, 2023
• Study Completion (Actual): November 17, 2023

Study Registration Dates

• First Submitted: March 30, 2019
• First Submitted That Met QC Criteria: March 30, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 50328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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