Clinical trial NCT01346007: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Idiopathic Nephrotic Syndrome
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2011-05-02
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Pneumococcal serotype-specific antibodies and B memory cells
timeFrame: Within the first 30 days after vaccination
Secondary outcomes:
measure: Incidence of relapses of idiopathic nephrotic syndrome
timeFrame: Within 12 months after vaccination
Other outcomes:
Locations:
city: Goudi
country: Greece
facility: 1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
state: Athens
Study officials:
affiliation: 1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
name: Maria Theodoridou, Dr
role: STUDY_CHAIR
affiliation: 1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
name: Vana Spoulou, Dr
role: STUDY_DIRECTOR
affiliation: 1st Department of Pediatrics, Division of Infectious Diseases 'Aghia Sophia' Children's Hospital, Athens University School of Medicine
name: Christina Liakou, MD
role: PRINCIPAL_INVESTIGATOR
References: