Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients

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.

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Key information

Conditions

Hemodialysis Renal Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

patients with known allergy to chicken proteins

Treatment and study plan

trivalent split influenza vaccine

Biological

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

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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2004
First posted: Oct 21, 2008
Registry last updated: Oct 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed