Back to resultsImproving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy
Primary Purpose
Lung Transplantation, Influenza Vaccines
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Trivalent Inactivated Influenza Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Lung Transplantation focused on measuring Influenza vaccine, Intradermal, Lung transplantation
Eligibility 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
Sites / Locations
- Multi-Organ Transplant Program, University Health Network
Outcomes
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
Full Information
NCT ID
NCT00402805
First Posted
November 21, 2006
Last Updated
April 15, 2008
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00402805
Brief Title
Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy
Official Title
Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
4. Oversight
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Transplantation, Influenza Vaccines
Keywords
Influenza vaccine, Intradermal, Lung transplantation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Trivalent Inactivated Influenza Vaccine
Primary Outcome Measure Information:
Title
HIA titers 4 weeks after influenza vaccination
Secondary Outcome Measure Information:
Title
Local and systemic adverse events to vaccination and rates
Title
of allograft rejection in the 6 months following vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepali Kumar, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Multi-Organ Transplant Program, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
10745238
Citation
Soesman NM, Rimmelzwaan GF, Nieuwkoop NJ, Beyer WE, Tilanus HW, Kemmeren MH, Metselaar HJ, de Man RA, Osterhaus AD. Efficacy of influenza vaccination in adult liver transplant recipients. J Med Virol. 2000 May;61(1):85-93.
Results Reference
background
PubMed Identifier
11829104
Citation
Mazzone PJ, Mossad SB, Mawhorter SD, Mehta AC, Schilz RJ, Maurer JR. The humoral immune response to influenza vaccination in lung transplant patients. Eur Respir J. 2001 Dec;18(6):971-6. doi: 10.1183/09031936.01.00215201.
Results Reference
background
PubMed Identifier
15525713
Citation
Belshe RB, Newman FK, Cannon J, Duane C, Treanor J, Van Hoecke C, Howe BJ, Dubin G. Serum antibody responses after intradermal vaccination against influenza. N Engl J Med. 2004 Nov 25;351(22):2286-94. doi: 10.1056/NEJMoa043555. Epub 2004 Nov 3.
Results Reference
background
PubMed Identifier
12096793
Citation
Vilchez RA, McCurry K, Dauber J, Lacono A, Griffith B, Fung J, Kusne S. Influenza virus infection in adult solid organ transplant recipients. Am J Transplant. 2002 Mar;2(3):287-91. doi: 10.1034/j.1600-6143.2002.20315.x.
Results Reference
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Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy
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