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Response to Live Attenuated Influenza Vaccine in Tonsillar Tissues and Blood

Response to Live Attenuated Influenza Vaccine in Tonsillar Tissues and Blood

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03884296
Acronym
FLU-Tonsil
Enrollment
0
Registered
2019-03-21
Start date
2019-04-15
Completion date
2023-11-17
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Obstructive sleep apnea, Quadrivalent live, attenuated influenza vaccine, Flumist

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.

Interventions

BIOLOGICALFluMist

Quadrivalent, live, attenuated influenza vaccine, intranasal spray

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 49 Years
Healthy volunteers
Yes

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/

Design outcomes

Primary

MeasureTime frameDescription
Plasma HAI titerDay 3-14 after receipt of LAIVHAI titer measures imune response to influenza vaccination
Number of Participants With Related Adverse EventsDay 0 to 14 post-immunizationWe will capture AEs to LAIV

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026