Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 4

Conditions: Hemodialysis; Renal Transplantation

Treatments: Biological: trivalent split influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT00776750

ML2394

Details and patient eligibility

About

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.

Enrollment: 407 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• patients with known allergy to chicken proteins

Trial design

407 participants in 1 patient group

influenza vaccination

Experimental group

Description:

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.

Treatment:

Biological: trivalent split influenza vaccine