Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients

Phase 4

Completed

• Conditions: Hemodialysis; Renal Transplantation

• 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

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2004-05
• Study Completion: 2004-05
• Status Verified: 2008-10
• Study First Submitted: 2008-10-20
• Study First Submitted QC: 2008-10-20
• Last Update Submitted: 2008-10-20
• Study First Posted: 2008-10-21
• Last Update Posted: 2008-10-21

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

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