Immune Response to Influenza Vaccination

Completed

• Conditions: Solid Organ Transplantation; Chronic Kidney Disease

• Registration Number: NCT00551837
• Lead Sponsor: The Cleveland Clinic

Brief Summary

The purpose of this study is to evaluate the immune response to a routine influenza vaccination. Influenza vaccination is given as part of routine standard of care in these individuals and is not part of the study protocol. The study will evaluate for a change in response to common antigens over time after influenza vaccination to determine if changes are related to the development of chronic rejection after solid-organ transplantation. We hypothesize that the influenza vaccine contributes to the alloreactivity of T cells verses common HLA types in the donor pool.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-10-30
• Study First Submitted QC: 2007-10-30
• Study First Posted: 2007-10-31
• Primary Completion: 2008-04
• Study Completion: 2008-05
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-20
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Transplant recipients (lung or kidney) 18 years or older, more than 3 months after transplantation
• Transplant candidates (kidney) 18 years or older, to recieve influenza vaccination
• Healthy volunteers to receive influenza vaccination

Exclusion Criteria

• Under 18 years of age
• Pregnant
• Medical contraindication for vaccine
• Transplant recipients receiving acute rejection therapy within one month
• Healthy volunteers with autoimmune disease or medications to mediate immune function
• Receipt of live, attenuated influenza vaccine, instead of injectable vaccine

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified