Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00402805
First received: November 21, 2006
Last updated: April 15, 2008
Last verified: November 2006
  Purpose

The purpose of this study is to test the specific humoral response after an intramuscular and intradermal influenza vaccination in lung transplant recipients


Condition Intervention Phase
Lung Transplantation
Influenza Vaccines
Biological: Trivalent Inactivated Influenza Vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • HIA titers 4 weeks after influenza vaccination

Secondary Outcome Measures:
  • Local and systemic adverse events to vaccination and rates
  • of allograft rejection in the 6 months following vaccination

Estimated Enrollment: 50
Study Start Date: October 2006
Study Completion Date: July 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Influenza virus is an important cause of morbidity in the lung transplant population and can lead to viral and bacterial pneumonia and contribute to the bronchiolitis obliterans syndrome. Although the annual influenza vaccine is recommended for lung transplant patients, studies have shown that a single intramuscular (i.m.) dose has poor immunogenicity. There are no studies that define the effect of intradermal doses in this population. We plan to study the immunogenicity of a two-dose regimen of influenza vaccine in 50 lung transplant patients during the 2006-2007 season. After the initial i.m. injection, a second dose will be given intradermally 4 weeks later. Antibody titers will be evaluated by a standard hemagglutination inhibition assay. We hypothesize that the second dose intradermally will significantly increase the proportion of vaccine responders.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lung transplant recipients 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402805

Locations
Canada, Ontario
Multi-Organ Transplant Program, University Health Network
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Deepali Kumar, MD University Health Network, Toronto
  More Information