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

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.

Study Overview

• Status: Unknown
• Conditions: Idiopathic Nephrotic Syndrome
• Intervention / Treatment: Biological: 7-valent pneumococcal conjugate vaccine

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Greece
  • Athens
    • Goudi, Athens, Greece, 11527
      • 1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 20 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: controls	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; Other Names: Prevenar; Wyeth Vaccines
ACTIVE_COMPARATOR: patients; Children with idiopathic nephrotic syndrome in remission treated with low-dose prednisolone and/or mycophenolate mofetil and/or cyclosporine A	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; Other Names: Prevenar; Wyeth Vaccines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pneumococcal serotype-specific antibodies and B memory cells	Within the first 30 days after vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of relapses of idiopathic nephrotic syndrome	Within 12 months after vaccination

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Investigators: Study Chair: Maria Theodoridou, Dr, 1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine; Study Director: Vana Spoulou, Dr, 1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine; Principal Investigator: Christina Liakou, MD, 1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ANTICIPATED): June 1, 2011

Study Registration Dates

• First Submitted: April 29, 2011
• First Submitted That Met QC Criteria: April 29, 2011
• First Posted (ESTIMATE): May 2, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 2, 2011
• Last Update Submitted That Met QC Criteria: April 29, 2011
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease; Syndrome; Nephrotic Syndrome; Nephrosis; Nephrosis, Lipoid; Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: NKU 7049687