Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deepali Kumar, University of Alberta
ClinicalTrials.gov Identifier:
NCT01149382
First received: June 22, 2010
Last updated: August 17, 2012
Last verified: August 2012

June 22, 2010
August 17, 2012
August 2010
August 2011   (final data collection date for primary outcome measure)
•Seroprotection rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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
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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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01149382
KUOA-03-ITP
No
Deepali Kumar, University of Alberta
University of Alberta
Not Provided
Principal Investigator: Deepali Kumar, MD University of Alberta
University of Alberta
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP