Overview

This trial is active, not recruiting.

Condition idiopathic nephrotic syndrome
Treatment 7-valent pneumococcal conjugate vaccine
Phase phase 4
Sponsor National and Kapodistrian University of Athens
Start date January 2009
End date June 2010
Trial size 50 participants
Trial identifier NCT01346007, NKU 7049687

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Children with idiopathic nephrotic syndrome in remission treated with low-dose prednisolone and/or mycophenolate mofetil and/or cyclosporine A
7-valent pneumococcal conjugate vaccine Prevenar; Wyeth Vaccines
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
(Active Comparator)
7-valent pneumococcal conjugate vaccine Prevenar; Wyeth Vaccines
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

Primary Outcomes

Measure
Pneumococcal serotype-specific antibodies and B memory cells
time frame: Within the first 30 days after vaccination

Secondary Outcomes

Measure
Incidence of relapses of idiopathic nephrotic syndrome
time frame: Within 12 months after vaccination

Eligibility Criteria

Male or female participants from 2 years up to 20 years old.

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

Additional Information

Official title Study of Safety, Immunogenicity and Immunological Memory of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome
Principal investigator Christina Liakou, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by National and Kapodistrian University of Athens.