Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients

Completed

• Conditions: Transplant

• Registration Number: NCT01149382
• Lead Sponsor: University of Alberta

Brief Summary

Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for organ transplant patients, studies have shown that the standard inactivated influenza vaccine has poor immunogenicity in this population. The investigators plan to test the humoral response to vaccination and look at HLA upregulation

Detailed Description

OBJECTIVE AND HYPOTHESIS

* To test the specific humoral response of the influenza vaccine after islet cell transplantation

* To test the production of HLA alloantibodies after vaccination.

Study Timeline

• Study First Submitted: 2010-06-22
• Study First Submitted QC: 2010-06-22
• Study First Posted: 2010-06-23
• Study Start: 2010-08
• Primary Completion: 2011-08
• Study Completion: 2011-12
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-17
• Last Update Posted: 2012-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Adult islet cell transplant recipients
• Able to provide informed consent

Exclusion Criteria

• Egg allergy
• Previous life-threatening reaction to influenza vaccine (ie Guillain Barre Syndrome)
• Febrile illness in the past two weeks
• Unable to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Seroprotection rate	3 months	defined as a post-vaccination titer of ≥1:40

Secondary Outcome Measures

Name	Time	Method
•Seroconversion rate	3 months	defined as a 4-fold increase in titer from pre- to post-vaccination.

Trial Locations

Locations (1)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada