Study of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome
This trial is active, not recruiting.
|Condition||idiopathic nephrotic syndrome|
|Treatment||7-valent pneumococcal conjugate vaccine|
|Sponsor||National and Kapodistrian University of Athens|
|Start date||January 2009|
|End date||June 2010|
|Trial size||50 participants|
|Trial identifier||NCT01346007, NKU 7049687|
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|
|Intervention model||parallel assignment|
Pneumococcal serotype-specific antibodies and B memory cells
time frame: Within the first 30 days after vaccination
Incidence of relapses of idiopathic nephrotic syndrome
time frame: Within 12 months after vaccination
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
|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 . 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.|
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