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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00402805
First Posted: November 22, 2006
Last Update Posted: April 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Health Network, Toronto
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Publications:
ClinicalTrials.gov Identifier: NCT00402805     History of Changes
Other Study ID Numbers: 06-0380-AE
First Submitted: November 21, 2006
First Posted: November 22, 2006
Last Update Posted: April 16, 2008
Last Verified: November 2006

Keywords provided by University Health Network, Toronto:
Influenza vaccine
Intradermal
Lung transplantation

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs