COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT00402805
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : April 16, 2008
Information provided by:
University Health Network, Toronto

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

Condition or disease Intervention/treatment Phase
Lung Transplantation Influenza Vaccines Biological: Trivalent Inactivated Influenza Vaccine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : October 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. HIA titers 4 weeks after influenza vaccination

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00402805

Layout table for location information
Canada, Ontario
Multi-Organ Transplant Program, University Health Network
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
Layout table for investigator information
Principal Investigator: Deepali Kumar, MD University Health Network, Toronto
Layout table for additonal information Identifier: NCT00402805    
Other Study ID Numbers: 06-0380-AE
First Posted: November 22, 2006    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: November 2006
Keywords provided by University Health Network, Toronto:
Influenza vaccine
Lung transplantation
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases