Clinical Trials Logo
  1. Home
  2. Idiopathic Nephrotic Syndrome
  3. NCT01346007

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

Idiopathic Nephrotic Syndrome Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01346007
Study type Interventional
Source National and Kapodistrian University of Athens
Contact
Status Active, not recruiting
Phase Phase 4
Start date January 2009
Completion date June 2011
View Details
See also
  Status Clinical Trial Phase
Completed NCT01609426 - Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome N/A
Completed NCT01092962 - Cyclophosphamide Versus Mycophenolate Mofetil for the Treatment of Steroid-dependent Nephrotic Syndrome in Children Phase 3
Recruiting NCT04075656 - UrApp for Childhood Nephrotic Syndrome Management (Incident Cohort) N/A
Recruiting NCT02896270 - Valproic Acid for Idiopathic Nephrotic Syndrome Phase 2/Phase 3
Completed NCT04034316 - Reduce Immunosuppression With Atmp in NS ChildrEn Phase 2
Completed NCT00255398 - Kidney Disease Biomarkers
Recruiting NCT04207580 - A National Prospective Cohort of Patients With Idiopathic Nephrotic Syndrome Beginning in Childhood.
Completed NCT04494438 - Rituximab for Idiopathic Nephrotic Syndrome Phase 3
Completed NCT04169776 - Effect of Daily Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Proteinuria in Pediatric Patients With Idiopathic Nephrotic Syndrome N/A
Recruiting NCT03298698 - Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome Phase 3
Recruiting NCT03949972 - The FOrMe Registry (The German Focal Segmental Glomerulosclerosis and Minimal Change Disease Registry)