Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients
Phase 4
Completed
- Conditions
- HemodialysisRenal Transplantation
- Interventions
- Biological: trivalent split influenza vaccine
- Registration Number
- NCT00776750
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 407
Inclusion Criteria
- maintenance hemodialysis patients or
- renal transplant recipients (beyond month 3 after transplantation)
Exclusion Criteria
- patients with known allergy to chicken proteins
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description influenza vaccination trivalent split influenza vaccine All 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.
- Primary Outcome Measures
Name Time Method Seroprotection rate, defined as the percentage of patients with an HI antibody titer ≥ 40,
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
University Hospital Leuven
🇧🇪Leuven, Belgium