Idiopathic Nephrotic Syndrome
Conditions
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.
Interventions
BIOLOGICAL7-valent pneumococcal conjugate vaccine
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
Sponsors
National and Kapodistrian University of Athens
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 20 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pneumococcal serotype-specific antibodies and B memory cells | Within the first 30 days after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of relapses of idiopathic nephrotic syndrome | Within 12 months after vaccination |
Countries
Greece
Outcome results
None listed