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

Phase 4

Completed

• Conditions: End Stage Renal Disease
• Interventions: Biological: 13-valent conjugate pneumococcal vaccine

• Registration Number: NCT01974817
• Lead Sponsor: Michigan State University

Brief Summary

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

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 Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-11-03
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2016-09
• Results First Submitted: 2016-09-27
• Results First Submitted QC: 2016-09-27
• Last Update Submitted: 2016-09-27
• Results First Posted: 2016-11-17
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccine	13-valent conjugate pneumococcal vaccine	Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.

Primary Outcome Measures

Name	Time	Method
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	12 months	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.

Trial Locations

Locations (1)

Sparrow Dialysis at Saint Lawrence Campus; 🇺🇸 Lansing, Michigan, United States