Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients

August 17, 2012 updated by: Deepali Kumar, University of Alberta

Humoral Immune Response To Influenza Vaccine In Islet Cell In Transplant Recipients

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • University of Alberta Hospital

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult islet cell transplant recipients

Description

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 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
islet cell transplant recipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
•Seroprotection rate
Time Frame: 3 months
defined as a post-vaccination titer of ≥1:40
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
•Seroconversion rate
Time Frame: 3 months
defined as a 4-fold increase in titer from pre- to post-vaccination.
3 months

Collaborators and Investigators

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

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Deepali Kumar, MD, University of Alberta

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

August 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 22, 2010

First Submitted That Met QC Criteria

June 22, 2010

First Posted (Estimate)

June 23, 2010

Study Record Updates

Last Update Posted (Estimate)

August 21, 2012

Last Update Submitted That Met QC Criteria

August 17, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KUOA-03-ITP

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.

Clinical Trials on Transplant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe