Response to Live Attenuated Influenza Vaccine in Tonsillar Tissues and Blood

Stanford University1 site in 1 countryApril 15, 2019

ConditionsInfluenza

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Influenza
Sponsor: Stanford University
Locations: 1
Primary Endpoint: Plasma HAI titer
Status: Withdrawn
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

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.

Registry

clinicaltrials.gov

Start Date

April 15, 2019

End Date

November 17, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Principal Investigator

Philip Grant

Assistant Professor of Medicine (Infectious Diseases)

Stanford University

Eligibility Criteria

Inclusion Criteria

•2-49-year-old male and female patients undergoing tonsillectomy for obstructive sleep apnea or other non-infectious indication.
•Willing and able to complete the informed consent process
•Availability for follow-up for the planned duration of the study
•Acceptable medical history by review of inclusion/exclusion criteria

Exclusion Criteria

•Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
•Life-threatening reactions to previous influenza vaccinations
•Asthma (contraindication for receipt of LAIV4)
•Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, arginine or MSG.
•Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
•History of immunodeficiency (including HIV infection)
•Known or suspected impairment of immunologic function; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease
•Hospitalization in the past year for congestive heart failure or emphysema.
•Chronic Hepatitis B or C.
•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.