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

Phase 4

• Conditions: Idiopathic Nephrotic Syndrome
• Interventions: Biological: 7-valent pneumococcal conjugate vaccine

• Registration Number: NCT01346007
• Lead Sponsor: National and Kapodistrian University of Athens

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.

Study Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Primary Completion: 2010-06
• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-04-29
• Last Update Submitted: 2011-04-29
• Study First Posted: 2011-05-02
• Last Update Posted: 2011-05-02
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controls	7-valent pneumococcal conjugate vaccine	-
patients	7-valent pneumococcal conjugate vaccine	Children with idiopathic nephrotic syndrome in remission treated with low-dose prednisolone and/or mycophenolate mofetil and/or cyclosporine A

Primary Outcome Measures

Name	Time	Method
Pneumococcal serotype-specific antibodies and B memory cells	Within the first 30 days after vaccination

Secondary Outcome Measures

Name	Time	Method
Incidence of relapses of idiopathic nephrotic syndrome	Within 12 months after vaccination

Trial Locations

Locations (1)

1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine; 🇬🇷 Goudi, Athens, Greece