Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients

Universitaire Ziekenhuizen KU Leuven1 site in 1 country407 target enrollmentSeptember 2003

ConditionsHemodialysis Renal Transplantation

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Hemodialysis
Sponsor: Universitaire Ziekenhuizen KU Leuven
Enrollment: 407
Locations: 1
Primary Endpoint: Seroprotection rate, defined as the percentage of patients with an HI antibody titer ≥ 40,
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

May 2004

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universitaire Ziekenhuizen KU Leuven

Eligibility Criteria

Inclusion Criteria

•maintenance hemodialysis patients or
•renal transplant recipients (beyond month 3 after transplantation)

Exclusion Criteria

•patients with known allergy to chicken proteins

Outcomes

Primary Outcomes

Seroprotection rate, defined as the percentage of patients with an HI antibody titer ≥ 40,

Secondary Outcomes

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.