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Tissue-specific Responses to Influenza Immunization and Their Relation to Blood Biomarkers (SLVP032)

Influenza Clinical Trial

Official title:
Tissue-specific Responses to Influenza Immunization and Their Relation to Blood Biomarkers. U19-HIPC Vaccination and Infection: Indicators of Immunological Health and Responsiveness

Clinical Trial Summary

The investigators collected blood and lymphoid tissues routinely discarded during surgery from adults after a routine seasonal influenza vaccination to determine how immune memory develops at the actual site of infection, and how immunization may alter this process.

Clinical Trial Description

This is a Phase IV study of licensed influenza vaccines with up to 30 male and female adults, 18-49 years of age that was halted due to the recommendation that live, attenuated influenza vaccine (LAIV) not be used as a seasonal flu vaccine. Volunteers were patients undergoing tonsillectomy for treatment of obstructive sleep apnea (OSA).

In the initial pilot phase of the study, up to 3 volunteers will be enrolled and will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4) given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy. Enrollment of the remaining study volunteers into the main portion of the study will begin once the initial pilot phase is completed. The remaining study volunteers will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4) intranasally.

The second study visit for all volunteers will occur at the time of the volunteer's tonsillectomy surgery, 3-14 days after Visit 01. A member of the surgical team will collect a 20 mL blood sample and a sample of the resected tonsil tissue that would otherwise be discarded to be distributed to the lab. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03023709
Study type Interventional
Source Stanford University
Contact
Status Terminated
Phase Phase 4
Start date September 2015
Completion date December 2015
View Details
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