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

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
13-valent conjugate pneumococcal vaccine
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring pneumococcal vaccine, end stage renal disease, dialysis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sparrow Dialysis at Saint Lawrence Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaccine

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2013
Last Updated
September 27, 2016
Sponsor
Michigan State University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01974817
Brief Title
Study Response of 13-valent Conjugate Pneumococcal Vaccine in Patients With End Stage Renal Disease
Official Title
Streptococcus Pneumoniae Colonization and Immunogenicity of 13-valent Conjugate Pneumococcal Vaccine in Patients 50 Years or Older With End Stage Renal Disease on Dialysis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
pneumococcal vaccine, end stage renal disease, dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccine
Arm Type
Experimental
Arm Description
Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.
Intervention Type
Biological
Intervention Name(s)
13-valent conjugate pneumococcal vaccine
Other Intervention Name(s)
Prevnar-13
Intervention Description
0.5ml IM for one dose
Primary Outcome Measure Information:
Title
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
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subhashis Mitra, M.D
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sparrow Dialysis at Saint Lawrence Campus
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27581438
Citation
Mitra S, Stein GE, Bhupalam S, Havlichek DH. Immunogenicity of 13-Valent Conjugate Pneumococcal Vaccine in Patients 50 Years and Older with End-Stage Renal Disease and on Dialysis. Clin Vaccine Immunol. 2016 Nov 4;23(11):884-887. doi: 10.1128/CVI.00153-16. Print 2016 Nov.
Results Reference
derived

Learn more about this trial

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

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