Lung Transplantation Clinical Trial
Official title:
Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy
Verified date | November 2006 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
The purpose of this study is to test the specific humoral response after an intramuscular and intradermal influenza vaccination in lung transplant recipients
Status | Completed |
Enrollment | 50 |
Est. completion date | July 2007 |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Lung transplant recipients greater than 3 months post-transplant Exclusion Criteria: - ยท 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | Multi-Organ Transplant Program, University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
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. Epub 2004 Nov 3. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HIA titers 4 weeks after influenza vaccination | |||
Secondary | Local and systemic adverse events to vaccination and rates | |||
Secondary | of allograft rejection in the 6 months following vaccination |
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