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

Phase 4CompletedNCT01974817

Michigan State University25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

13-valent conjugate pneumococcal vaccineBIOLOGICAL

0.5ml IM for one dose

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Sparrow Dialysis at Saint Lawrence Campus

Lansing, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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