Response to Live Attenuated Influenza Vaccine in Tonsillar Tissues and Blood (FLU-Tonsil)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03884296|
Recruitment Status : Active, not recruiting
First Posted : March 21, 2019
Last Update Posted : March 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: FluMist||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Response to Live Attenuated Influenza Vaccine in Tonsillar Tissues and Blood|
|Actual Study Start Date :||April 15, 2019|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2024|
Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.
Quadrivalent, live, attenuated influenza vaccine, intranasal spray
- Plasma HAI titer [ Time Frame: Day 3-14 after receipt of LAIV ]HAI titer measures imune response to influenza vaccination
- Number of Participants With Related Adverse Events [ Time Frame: Day 0 to 14 post-immunization ]We will capture AEs to LAIV
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884296
|United States, California|
|Stanford University Medical Center, Lane building L134|
|Stanford, California, United States, 94305|