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Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients

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ClinicalTrials.gov Identifier: NCT01149382
Recruitment Status : Completed
First Posted : June 23, 2010
Last Update Posted : August 21, 2012
Sponsor:
Information provided by (Responsible Party):
Deepali Kumar, University of Alberta

Brief 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

Condition or disease
Transplant

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.

Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Humoral Immune Response To Influenza Vaccine In Islet Cell In Transplant Recipients
Study Start Date : August 2010
Primary Completion Date : August 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
islet cell transplant recipients



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


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



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

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

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

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