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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by National and Kapodistrian University of Athens.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier:
NCT01346007
First received: April 29, 2011
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Idiopathic Nephrotic Syndrome
 Biological: 7-valent pneumococcal conjugate vaccine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of Safety, Immunogenicity and Immunological Memory of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Memory
U.S. FDA Resources

Further study details as provided by National and Kapodistrian University of Athens:

Primary Outcome Measures:
  • Pneumococcal serotype-specific antibodies and B memory cells [ Time Frame: Within the first 30 days after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of relapses of idiopathic nephrotic syndrome [ Time Frame: Within 12 months after vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2009
Estimated Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Prevenar; Wyeth Vaccines
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 Name: Prevenar; Wyeth Vaccines

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.

  Eligibility

Ages Eligible for Study:   2 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346007

Locations
Greece
1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
Goudi, Athens, Greece, 11527
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Dr Vana Spoulou, 1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
ClinicalTrials.gov Identifier: NCT01346007     History of Changes
Other Study ID Numbers: NKU 7049687
Study First Received: April 29, 2011
Last Updated: April 29, 2011
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Nephrosis, Lipoid
Nephrotic Syndrome
Nephrosis
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013