Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Disease Patients
|Decreased Immunologic Activity [PE] Influenza Rejection||Biological: Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)||Phase 4|
|Study Design:||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.|
- 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 ]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.
- 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 ]To measure the Anti-HLA and anti-MICA antibodies with luminex-test
|Study Start Date:||October 2009|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298102
|Brussels, Brabant, Belgium, 1070|
|Study Director:||Daniel Abramowicz, PhD||Hospital Erasme|