Study Response of 13-valent Conjugate Pneumococcal Vaccine in Patients With End Stage Renal Disease

Study Overview
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Brief Summary
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The purpose of the study is to determine the response of 13-valent conjugate pneumococcal vaccine in patients 50 years or older with end stage renal disease on dialysis. The study will also try to determine Streptococcus pneumoniae colonization in patients 50 years or older with end stage renal disease on dialysis.

Detailed Description
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The purpose of the study is to determine the immunogenicity of 13-valent conjugate pneumococcal vaccine in patients 50 years or older with end stage renal disease on dialysis. Patients will receive one dose of 0.5ml of Prevnar-13 intra-muscularly. Antibody response to pneumococcal serotypes will be studied ar 2months and 12 months after administration of vaccine. The study will try to determine Streptococcus pneumoniae colonization in patients 50 years or older with end stage renal disease on dialysis and also investigate if there are any change in Streptococcus pneumoniae colonization after Prevnar-13 vaccination.

Official Title
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Streptococcus Pneumoniae Colonization and Immunogenicity of 13-valent Conjugate Pneumococcal Vaccine in Patients 50 Years or Older With End Stage Renal Disease on Dialysis.

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Biological: 13-valent conjugate pneumococcal vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients ≥ 50years of age with End stage renal disease on dialysis (both hemodialysis and peritoneal dialysis). Scheduled to receive pneumococcal vaccine either after 5years of previous vaccination or starting vaccination as part of standard care during the study period Exclusion Criteria: History of S. pneumoniae infection within the last 5 years Vaccinated with an influenza- or diphtheria-containing vaccine within the last 6 months History of any severe adverse reaction associated with a vaccine Received gamma-globulins within the previous 6 months Known or suspected HIV or on immunosuppressive medications. Functional or anatomic asplenia serious chronic medical condition

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine<br>Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly. | Biological: 13-valent conjugate pneumococcal vaccine<br>* 0.5ml IM for one dose<br>* Other names: Prevnar-13;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis | Study the immunologic response after administration of single dose 13-valent conjugate pneumococcal vaccine in patients 50 years or older with end stage renal disease on dialysis. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumococcal vaccine, end stage renal disease, dialysis