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

NCT ID: NCT01974817

Last Updated: 2016-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-12-31

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.

Conditions

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End Stage Renal Disease

Keywords

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pneumococcal vaccine end stage renal disease dialysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vaccine

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

Group Type EXPERIMENTAL

13-valent conjugate pneumococcal vaccine

Intervention Type BIOLOGICAL

0.5ml IM for one dose

Interventions

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13-valent conjugate pneumococcal vaccine

0.5ml IM for one dose

Intervention Type BIOLOGICAL

Other Intervention Names

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Prevnar-13

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Subhashis Mitra

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Subhashis Mitra, M.D

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

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Sparrow Dialysis at Saint Lawrence Campus

Lansing, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27581438 (View on PubMed)

Other Identifiers

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WI170883

Identifier Type: -

Identifier Source: org_study_id