Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2006
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 21, 2006
CompletedFirst Posted
Study publicly available on registry
November 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedApril 16, 2008
November 1, 2006
4 months
November 21, 2006
April 15, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HIA titers 4 weeks after influenza vaccination
Secondary Outcomes (2)
Local and systemic adverse events to vaccination and rates
of allograft rejection in the 6 months following vaccination
Interventions
Eligibility Criteria
You may qualify if:
- Lung transplant recipients greater than 3 months post-transplant
You may not qualify if:
- · 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Multi-Organ Transplant Program, University Health Network
Toronto, Ontario, M5G 2N2, Canada
Related Publications (4)
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.
PMID: 10745238BACKGROUNDMazzone 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.
PMID: 11829104BACKGROUNDBelshe 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.
PMID: 15525713BACKGROUNDVilchez 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.
PMID: 12096793BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deepali Kumar, MD
University Health Network, Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 21, 2006
First Posted
November 22, 2006
Study Start
October 1, 2006
Primary Completion
February 1, 2007
Study Completion
July 1, 2007
Last Updated
April 16, 2008
Record last verified: 2006-11