Immune Response to Influenza Vaccination

October 20, 2017 updated by: The Cleveland Clinic
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

82

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Lung and kidney transplant recipients, patients with chronic kidney disease and healthy controls

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

University Hospitals Cleveland Medical Center

Investigators

  • Study Director: Emilio Poggio, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

October 30, 2007

First Posted (Estimate)

October 31, 2007

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 20, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-12-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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