Study of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome
Primary Purpose
Idiopathic Nephrotic Syndrome
Status
Unknown status
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
7-valent pneumococcal conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Idiopathic Nephrotic Syndrome
Eligibility Criteria
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
Sites / Locations
- 1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
patients
controls
Arm Description
Children with idiopathic nephrotic syndrome in remission treated with low-dose prednisolone and/or mycophenolate mofetil and/or cyclosporine A
Outcomes
Primary Outcome Measures
Pneumococcal serotype-specific antibodies and B memory cells
Secondary Outcome Measures
Incidence of relapses of idiopathic nephrotic syndrome
Full Information
NCT ID
NCT01346007
First Posted
April 29, 2011
Last Updated
April 29, 2011
Sponsor
National and Kapodistrian University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT01346007
Brief Title
Study of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome
Official Title
Study of Safety, Immunogenicity and Immunological Memory of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National and Kapodistrian University of Athens
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Nephrotic Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients
Arm Type
Active Comparator
Arm Description
Children with idiopathic nephrotic syndrome in remission treated with low-dose prednisolone and/or mycophenolate mofetil and/or cyclosporine A
Arm Title
controls
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
7-valent pneumococcal conjugate vaccine
Other Intervention Name(s)
Prevenar; Wyeth Vaccines
Intervention Description
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 Outcome Measure Information:
Title
Pneumococcal serotype-specific antibodies and B memory cells
Time Frame
Within the first 30 days after vaccination
Secondary Outcome Measure Information:
Title
Incidence of relapses of idiopathic nephrotic syndrome
Time Frame
Within 12 months after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Theodoridou, Dr
Organizational Affiliation
1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vana Spoulou, Dr
Organizational Affiliation
1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christina Liakou, MD
Organizational Affiliation
1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
City
Goudi
State/Province
Athens
ZIP/Postal Code
11527
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Study of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome
We'll reach out to this number within 24 hrs