Response to Live Attenuated Influenza Vaccine in Tonsillar Tissues and Blood (FLU-Tonsil)

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 investigate the immune response to a nasal flu immunization in tonsillar tissue compared to what can be measured in the blood.

Study Overview

• Status: Withdrawn
• Conditions: Influenza
• Intervention / Treatment: Biological: FluMist

Detailed Description

This is a Phase IV study of licensed influenza vaccines with up to 50 male and female volunteers, 2-49 years of age. Volunteers were patients undergoing tonsillectomy for treatment of obstructive sleep apnea (OSA) or other non-infectious indication as part of their routine medical care.

The investigator intends to collect blood and lymphoid tissues routinely discarded during surgery from adults and children after routine seasonal live attenuated influenza vaccination (LAIV) to determine how immune memory develops at the actual site of infection, and how immunization may alter this process.

The first research study visit will take place approximately 3-14 days prior to the scheduled date of tonsillectomy surgery. During this visit, 20 mL blood sample will be obtained and participants will receive FluMist (intranasal, quadrivalent, live-attenuated influenza vaccine). This is one of the routinely available and recommended vaccines for the age groups included in this study.

The second study visit will take place on the same day of the scheduled surgery for the tonsillectomy. Another blood sample (maximum volume of 20 mL) will be collected along with the discarded tonsillar tissue. Blood and tissues will be sent to the lab.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Philip Grant, MD; 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: 2 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 2-49-year-old male and female patients undergoing tonsillectomy for obstructive sleep apnea or other non-infectious indication.
2. Willing and able to complete the informed consent process
3. Availability for follow-up for the planned duration of the study
4. 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. Asthma (contraindication for receipt of LAIV4)
4. Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, arginine or MSG.
5. Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
6. History of immunodeficiency (including HIV infection)
7. Known or suspected impairment of immunologic function; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease
8. Hospitalization in the past year for congestive heart failure or emphysema.
9. Chronic Hepatitis B or C.
10. 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.
11. Participants in close contact with anyone who has a severely weakened immune system
12. 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).
13. 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.
14. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
15. 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.
16. Receipt of blood or blood products within the past 6 months or planned used during the study.
17. A medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
18. Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned vaccinations prior to completion of last study visit (~ 14 days after study vaccination)
19. Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned vaccination prior to completion of last study visit (~ 14 days after study enrollment)
20. Need for allergy immunization (that cannot be postponed) until after the last study visit.
21. History of Guillain-Barre# syndrome
22. Pregnant or breastfeeding woman
23. Use of investigational agents within 30 days prior to enrollment or planned use during the study.
24. 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.
25. Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.

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 quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.	Biological: FluMist; Quadrivalent, live, attenuated influenza vaccine, intranasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma HAI titer	HAI titer measures imune response to influenza vaccination	Day 3-14 after receipt of LAIV
Number of Participants With Related Adverse Events	We will capture AEs to LAIV	Day 0 to 14 post-immunization

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 15, 2019
• Primary Completion (Actual): November 17, 2023
• Study Completion (Actual): November 17, 2023

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

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

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; Quadrivalent live, attenuated influenza vaccine; Flumist
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 50122; 5U19AI057229-15 (U.S. NIH Grant/Contract)

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