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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
June 22, 2010
June 23, 2010
August 21, 2012
August 2010
August 2011   (Final data collection date for primary outcome measure)
•Seroprotection rate [ Time Frame: 3 months ]
defined as a post-vaccination titer of ≥1:40
Same as current
Complete list of historical versions of study NCT01149382 on ClinicalTrials.gov Archive Site
•Seroconversion rate [ Time Frame: 3 months ]
defined as a 4-fold increase in titer from pre- to post-vaccination.
Same as current
Not Provided
Not Provided
 
Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients
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

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Adult islet cell transplant recipients
Transplant
Not Provided
islet cell transplant recipients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
December 2011
August 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01149382
KUOA-03-ITP
No
Not Provided
Not Provided
Deepali Kumar, University of Alberta
University of Alberta
Not Provided
Principal Investigator: Deepali Kumar, MD University of Alberta
University of Alberta
August 2012