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

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Safety and Efficacy of Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Transplant and Dialyzed Patients: a Prospective Cohort Study.

Conditions
-----------------
Decreased Immunologic Activity [PE], Influenza, Rejection

Intervention / Treatment
-----------------
* Biological: Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Haemodialyzed patients Renal transplant recipients who have stable renal function for the last 3 months Exclusion Criteria: No pneumonia or severe infection during 1 month before vaccination No Ivig (intravenous immunoglobulins) treatment during the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: influenza vaccine<br>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)<br>* intramuscular injection of 1 dose vaccine<br>* Other names: Pandemrix;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine the efficacy aand safety of influenza A/H1N1 adjuvanted-vaccination among renal transplant and haemodialyzed patients as compared to controls | 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. | one month post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to controls and to assess the safety of the vaccine among renal transplanted patients by studying HLA or MICA sensitization before and following vaccination | To measure the Anti-HLA and anti-MICA antibodies with luminex-test | follow-up 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney, transplantation, haemodialysis, vaccination, influenza H1N1 2009