Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients
1 other identifier
interventional
407
1 country
1
Brief Summary
Disturbances of acquired immunity are considered to be responsible, at least partly, for the high infection rate and inadequate response to vaccinations observed in hemodialysis (HD) patients and renal transplant recipient (RTR). The present prospective trial aims at (a) evaluating the immunogenicity of a standard influenza vaccine in HD and RTR patients and (b) at identifying determinants of the immune response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2003
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 20, 2008
CompletedFirst Posted
Study publicly available on registry
October 21, 2008
CompletedOctober 21, 2008
October 1, 2008
8 months
October 20, 2008
October 20, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Seroprotection rate, defined as the percentage of patients with an HI antibody titer ≥ 40,
Secondary Outcomes (1)
Seroresponse rate, defined as the percentage of patients with a fourfold rise in HI titer after vaccination; impact of booster vaccination on the immune response, and safety of influenza vaccination.
Study Arms (1)
influenza vaccination
EXPERIMENTALAll participants received a standard dose of 0.5 ml commercially available trivalent split influenza vaccine (Vaxigrip®, Aventis Pasteur MSD) by intramuscular injection. The vaccine contained 15 μg hemagglutinin of each of the following influenza strains: A/ New Caledonia/20/99 (H1N1), A/ Panama/2007/99 (H3N2), and B/Shangdong/7/97, recommended by WHO as components of the influenza vaccine for the epidemic season 2003/2004.
Interventions
standard dose of 0.5 ml commercially available trivalent split influenza vaccine (Vaxigrip®, Aventis Pasteur MSD) by intramuscular injection
Eligibility Criteria
You may qualify if:
- maintenance hemodialysis patients or
- renal transplant recipients (beyond month 3 after transplantation)
You may not qualify if:
- patients with known allergy to chicken proteins
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Leuven
Leuven, 3000, Belgium
Related Publications (1)
Scharpe J, Peetermans WE, Vanwalleghem J, Maes B, Bammens B, Claes K, Osterhaus AD, Vanrenterghem Y, Evenepoel P. Immunogenicity of a standard trivalent influenza vaccine in patients on long-term hemodialysis: an open-label trial. Am J Kidney Dis. 2009 Jul;54(1):77-85. doi: 10.1053/j.ajkd.2008.11.032. Epub 2009 Apr 1.
PMID: 19339089DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Yves Vanrenterghem, MD, PhD
Universitaire Ziekenhuizen KU Leuven
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 20, 2008
First Posted
October 21, 2008
Study Start
September 1, 2003
Primary Completion
May 1, 2004
Study Completion
May 1, 2004
Last Updated
October 21, 2008
Record last verified: 2008-10