NCT01346007

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: 2 Years – 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Idiopathic Nephrotic Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	7-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

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-06-01
• Completion: 2011-06-01
• First posted: 2011-05-02
• Last updated: 2011-05-02

Locations

1 site across 1 country: Greece