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NCT01149382 Clinical Trial

Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients

Transplant Clinical Trial

Official title:
Humoral Immune Response To Influenza Vaccine In Islet Cell In Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01149382
Other study ID # KUOA-03-ITP
Secondary ID
Status Completed
Phase N/A
First received June 22, 2010
Last updated August 17, 2012
Start date August 2010
Est. completion date December 2011

Study information
Verified date August 2012
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 61
Est. completion date December 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada University of Alberta Hospital Edmonton Alberta

Sponsors (1)
Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary •Seroprotection rate defined as a post-vaccination titer of =1:40 3 months Yes
Secondary •Seroconversion rate defined as a 4-fold increase in titer from pre- to post-vaccination. 3 months Yes
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