Study Response of 13-valent Conjugate Pneumococcal Vaccine in Patients With End Stage Renal Disease
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 4/2/2016 |
Start Date: | May 2013 |
End Date: | December 2014 |
Streptococcus Pneumoniae Colonization and Immunogenicity of 13-valent Conjugate Pneumococcal Vaccine in Patients 50 Years or Older With End Stage Renal Disease on Dialysis.
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.
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.
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.
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.
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
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