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

End Stage Renal Disease Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01974817
• Other study ID #: WI170883
• Status: Recruiting
• Phase: Phase 4
• First received: October 28, 2013
• Last updated: November 4, 2013
• Start date: May 2013
• Est. completion date: December 2014

Study information

• Verified date: November 2013
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Biological:
• 13-valent conjugate pneumococcal vaccine
0.5ml IM for one dose

Locations

Country	Name	City	State
United States	Sparrow Dialysis at Saint Lawrence Campus	Lansing	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity of 13-valent conjugate pneumococcal vaccine 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.	2 months	No