NCT03884296

Response to Live Attenuated Influenza Vaccine in Tonsillar Tissues and Blood

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 2 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	FluMist	Quadrivalent, live, attenuated influenza vaccine, intranasal spray

Timeline

• Start date: 2019-04-15
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2019-03-21
• Last updated: 2023-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study