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Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01149382
First Posted: June 23, 2010
Last Update Posted: August 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Deepali Kumar, University of Alberta
  Purpose
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

Condition
Transplant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Humoral Immune Response To Influenza Vaccine In Islet Cell In Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Deepali Kumar, University of Alberta:

Primary Outcome Measures:
  • •Seroprotection rate [ Time Frame: 3 months ]
    defined as a post-vaccination titer of ≥1:40


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


Enrollment: 61
Study Start Date: August 2010
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
islet cell transplant recipients

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult islet cell transplant recipients
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149382


Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Deepali Kumar, MD University of Alberta
  More Information

Responsible Party: Deepali Kumar, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01149382     History of Changes
Other Study ID Numbers: KUOA-03-ITP
First Submitted: June 22, 2010
First Posted: June 23, 2010
Last Update Posted: August 21, 2012
Last Verified: August 2012

Keywords provided by Deepali Kumar, University of Alberta:
flu shot
islet cell transplant recipients