Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Disease Patients

This study has been completed.
Sponsor:
Information provided by:
Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT01298102
First received: February 16, 2011
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

In 2009, the pandemic influenza A/H1N1 accounted for worldwide recommendations about vaccination. There is no data concerning the immunogenicity nor the security of the adjuvanted-A/H1N1 vaccine in renal disease patients. The aim of this study is to observe the effects of this vaccine on transplanted and hemodialyzed patients.


Condition Intervention Phase
Decreased Immunologic Activity [PE]
Influenza
Rejection
Biological: Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Transplant and Dialyzed Patients: a Prospective Cohort Study.

Resource links provided by NLM:


Further study details as provided by Erasme University Hospital:

Primary Outcome Measures:
  • to determine the efficacy aand safety of influenza A/H1N1 adjuvanted-vaccination among renal transplant and haemodialyzed patients as compared to controls [ Time Frame: one month post-vaccination ] [ Designated as safety issue: Yes ]
    measures of anti-A/H1N1 antibodies with a method of microneutralizing test (seroneutralization) to follow-up the secondary effects of the vaccine and follow-up of renal function in renal transplanted patients.


Secondary Outcome Measures:
  • to controls and to assess the safety of the vaccine among renal transplanted patients by studying HLA or MICA sensitization before and following vaccination [ Time Frame: follow-up 6 months ] [ Designated as safety issue: Yes ]
    To measure the Anti-HLA and anti-MICA antibodies with luminex-test


Enrollment: 185
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: influenza vaccine
Pandemrix vaccine (Influenza A/H1N1 2009)to be injected to renal transplant patients, haemodialyzed patients, and controls
Biological: Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)
intramuscular injection of 1 dose vaccine
Other Name: Pandemrix

Detailed Description:

The serologic responses to the Pandemrix vaccine will assess the efficacy, with the determination of the seroconversion rate among the patients.

The anti-HLA and anti-MICA antibodies will be determined to assess the safety among the renal transplanted patients.

  Eligibility

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

Inclusion Criteria:

  1. Adult patients
  2. Haemodialyzed patients
  3. Renal transplant recipients who have stable renal function for the last 3 months

Exclusion Criteria:

  1. No pneumonia or severe infection during 1 month before vaccination
  2. No Ivig (intravenous immunoglobulins) treatment during the last 3 months
  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: NCT01298102

Locations
Belgium
Hospital Erasme
Brussels, Brabant, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
Investigators
Study Director: Daniel Abramowicz, PhD Hospital Erasme
  More Information

Publications:
Responsible Party: Broeders Nilufer, Hospital Erasme
ClinicalTrials.gov Identifier: NCT01298102     History of Changes
Other Study ID Numbers: Etude 2009/INT044
Study First Received: February 16, 2011
Last Updated: February 16, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by Erasme University Hospital:
kidney
transplantation
haemodialysis
vaccination
influenza H1N1 2009

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014