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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
History of Changes
  Purpose

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
Transplant

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:

U.S. FDA Resources

Further study details as provided by University of Alberta:

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


Secondary Outcome Measures:
  • •Seroconversion rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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)
Groups/Cohorts
islet cell transplant recipients

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013