Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients

This study has been completed.
Information provided by (Responsible Party):
Deepali Kumar, University of Alberta Identifier:
First received: June 22, 2010
Last updated: August 17, 2012
Last verified: August 2012
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 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 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)
islet cell transplant recipients

Detailed Description:


  • To test the specific humoral response of the influenza vaccine after islet cell transplantation
  • To test the production of HLA alloantibodies after vaccination.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01149382

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

Responsible Party: Deepali Kumar, Assistant Professor, University of Alberta Identifier: NCT01149382     History of Changes
Other Study ID Numbers: KUOA-03-ITP
Study First Received: June 22, 2010
Last Updated: August 17, 2012

Keywords provided by University of Alberta:
flu shot
islet cell transplant recipients processed this record on May 25, 2017