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Cell-mediated Immune Response to Influenza Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deepali Kumar, University of Alberta
ClinicalTrials.gov Identifier:
NCT00677547
First received: May 12, 2008
Last updated: September 13, 2011
Last verified: September 2011
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. One major hurdle in the evaluation of the response of influenza vaccine in immunocompromised patients is the lack of correlation between humoral response and efficacy of the vaccine. In patients with poor immune responses, cellular immunity may have a better correlation than humoral immunity with vaccine protection. We plan to assess the utility of 3 assays that evaluate the cell-mediated immune response (granzyme B, interleukin-10 (IL-10), and interferon-gamma (IFN-)) after influenza vaccine in kidney transplant recipients. Results from this study have the potential to directly improve patient care. The new monitoring assays may more accurately determine the risk for development of influenza infection, and therefore allowing a better prevention strategy.


Condition Phase
Kidney Transplant
 Phase 1

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Humoral and Cell-mediated Immune Response to Influenza Vaccine in Kidney Tranpslant Recipients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Correlation between the levels of Granzyme B and the IFN-/IL-10 ratio and the humoral response (HIA titers of 1:40, or serological response with a four-fold or greater increase in HI antibody titers), in the transplant and the control groups. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local and systemic adverse events to vaccination. Rates of allograft rejection in the 6 months following vaccination Documented influenza infection (by direct fluorescent antibody, viral culture, or PCR) in the 6 months following vaccination [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: November 2007
Study Completion Date: June 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Kidney transplant recipients
2
Healthy volunteers

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult kidney transplant recipients and healthy volunteers (enrolled among hospital staff)

Criteria

Adult kidney transplant recipients:

Inclusion Criteria:

  • Age ≥ 18
  • Greater than 3 months post-transplant

Exclusion Criteria:

  • Egg allergy
  • Previous life-threatening reaction to influenza vaccine (ie Guillain Barre Syndrome)
  • On anticoagulants such as warfarin that precludes intramuscular injection
  • Ongoing therapy for rejection
  • Febrile illness in the past two weeks
  • Unable to provide informed consent

Healthy volunteers

Inclusion Criteria:

- Age ≥ 18

Exclusion Criteria:

  • Egg allergy
  • Previous life-threatening reaction to influenza vaccine (ie Guillain Barre Syndrome)
  • On anticoagulants such as warfarin that precludes intramuscular injection
  • On immunosuppressive medication (prednisone, immunomodulators for autoimmune diseases)
  • Underlying autoimmune disease (eg, sarcoid, lupus, rheumatoid arthritis, Crohn's disease)
  • 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: NCT00677547

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

Publications:

Responsible Party: Deepali Kumar, Assistant Professor of Medicine, University of Alberta
ClinicalTrials.gov Identifier: NCT00677547     History of Changes
Other Study ID Numbers: 7061
Study First Received: May 12, 2008
Last Updated: September 13, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Kidney
Influenza vaccine
CMI

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 21, 2013