Comparison of the efficacy of pneumococcal and tetanus vaccination between hemodialysis patients and renal tranpslant recipients treated with Mycophenolic acid(VACC-IR) study. - VACC-IR

Conditions: Patients on dialysis and waiting for renal transplant and renal translanted patients

Registration Number: EUCTR2006-001806-94-BE

Lead Sponsor: Hôpital Erasme

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 90

Inclusion Criteria

1- adult patient aged between 18 and 75 years
2- patients transplanted between 1 and 5 years previously; with a kidney graft only, or dialyzed patients registred on the waiting list for a kidney transplant (or with ongoing registration)
3- renal transplant recipients treated with mycophenolic acid and a calcineurin inhibitor for at least 3 months
4- renal transplant recipients who did not experience a rejection episode during the last 6 months, and have stable renal fonctuion for the last 5 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1- no pneumonia or severe infection during 1 mont before vaccination
2- no pneumococcal or tetanos vaccination during the last 5 years
3-no Ivig (intravenous immunoglobulins) treatment during the last 3 months

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare renal transplant reicipients and dialyzed patients for the proportion developing an antibocy response to 23-valent pneumococcal polysaccharid vaccine;Secondary Objective: To compare renal transplant recipients and dialyzed patients for the proportion developing an antibody response to the tetanus toxoid vaccine<br>To evaluate the proportion of renal transplant reicipients and dialyzed patients who develop an adequate response to the heptavalent proteic-conjugate pneumoccal vaccine in case of unresponsiveness to the 23-valent polysaccharide vaccine;Primary end point(s): To compare the antibody responses to vaccines to vaccines in stable renal transplant recipient treated with Mycophenolic acid, as compared to dialyzed patients listed for transplantation and awaiting for renal graft

Secondary Outcome Measures