Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients

Universitaire Ziekenhuizen KU Leuven407 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

407

Conditions

Hemodialysis Renal Transplantation

Interventions

trivalent split influenza vaccineBIOLOGICAL

standard dose of 0.5 ml commercially available trivalent split influenza vaccine (Vaxigrip®, Aventis Pasteur MSD) by intramuscular injection

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * maintenance hemodialysis patients or * renal transplant recipients (beyond month 3 after transplantation) Exclusion Criteria: * patients with known allergy to chicken proteins

Locations (1)

University Hospital Leuven

Leuven, Belgium

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.

Data from ClinicalTrials.gov

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