Study of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether 7-valent pneumococcal conjugate vaccine safely induces immune responses and immunological memory in children with idiopathic nephrotic syndrome in remission.

Detailed Description
-----------------
Idiopathic nephrotic syndrome (INS) is the most frequent glomerular disease in children under 16 years old with incidence rate 2-7/100,000 patients/year depending on ethnicity. Those patients are susceptible to invasive pneumococcal disease (IPD) including peritonitis, pneumonia with or without pleural effusion and meningitis. Due to increased mortality and risk of relapses associated with IPD, it has been recommended that children with INS should be immunized with pneumococcal conjugate vaccine [1]. However, concerns on vaccine safety and impaired immunogenicity due to INS pathogenesis and immunosuppressive treatment are a hurdle for universal implementation of existing guidelines. To thoroughly evaluate safety of 7-valent pneumococcal conjugate vaccine (PCV7) in children with INS in remission, we will investigate a possible association of vaccination with increased risk for recurrences of INS. We will also study immunogenicity and kinetics of immune response in INS patients and healthy subjects and the effect of different types of treatment on primary immune response and antibody persistence at 12-14 months following vaccination with PCV7.

Official Title
-----------------
Study of Safety, Immunogenicity and Immunological Memory of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome

Conditions
-----------------
Idiopathic Nephrotic Syndrome

Intervention / Treatment
-----------------
* Biological: 7-valent pneumococcal conjugate vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female Between 2-20 years of age Exclusion Criteria: serious allergic reaction to previous vaccination history of invasive pneumococcal disease vaccination with pneumococcal conjugate vaccine vaccination with pneumococcal polysaccharide vaccine administration of intravenous immunoglobulin or other blood products during the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patients<br>Children with idiopathic nephrotic syndrome in remission treated with low-dose prednisolone and/or mycophenolate mofetil and/or cyclosporine A | Biological: 7-valent pneumococcal conjugate vaccine<br>* A 0,5 ml dose of 7-valent pneumococcal conjugate vaccine in both arms A 0,5 ml anamnestic dose of 7-valent pneumococcal conjugate vaccine in subjects with idiopathic nephrotic syndrome 12 months after priming<br>* Other names: Prevenar; Wyeth Vaccines;|
| Active Comparator: controls<br> | Biological: 7-valent pneumococcal conjugate vaccine<br>* A 0,5 ml dose of 7-valent pneumococcal conjugate vaccine in both arms A 0,5 ml anamnestic dose of 7-valent pneumococcal conjugate vaccine in subjects with idiopathic nephrotic syndrome 12 months after priming<br>* Other names: Prevenar; Wyeth Vaccines;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumococcal serotype-specific antibodies and B memory cells |  | Within the first 30 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of relapses of idiopathic nephrotic syndrome |  | Within 12 months after vaccination |