Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00776750
First received: October 20, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hemodialysis
Renal Transplantation
Biological: trivalent split influenza vaccine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Seroprotection rate, defined as the percentage of patients with an HI antibody titer ≥ 40,

Secondary Outcome Measures:
  • 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. [ Designated as safety issue: Yes ]

Enrollment: 407
Study Start Date: September 2003
Estimated Study Completion Date: May 2004
Estimated Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: influenza vaccination
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.
Biological: trivalent split influenza vaccine
standard dose of 0.5 ml commercially available trivalent split influenza vaccine (Vaxigrip®, Aventis Pasteur MSD) by intramuscular injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with known allergy to chicken proteins
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776750

Locations
Belgium
University Hospital Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Yves Vanrenterghem, MD, PhD Universitaire Ziekenhuizen Leuven
  More Information

No publications provided by Universitaire Ziekenhuizen Leuven

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00776750     History of Changes
Other Study ID Numbers: ML2394
Study First Received: October 20, 2008
Last Updated: October 20, 2008
Health Authority: Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on October 19, 2014