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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Michigan State University
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Subhashis Mitra, Michigan State University
ClinicalTrials.gov Identifier:
NCT01974817
First received: October 28, 2013
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
End Stage Renal Disease
Biological: 13-valent conjugate pneumococcal vaccine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • Immunogenicity of 13-valent conjugate pneumococcal vaccine in in patients 50 years or older with end stage renal disease on dialysis [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine
Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.
Biological: 13-valent conjugate pneumococcal vaccine
0.5ml IM for one dose
Other Name: Prevnar-13

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974817

Locations
United States, Michigan
Sparrow Dialysis at Saint Lawrence Campus Recruiting
Lansing, Michigan, United States, 48195
Contact: Mary Swails, RN    517-364-7373      
Principal Investigator: Subhashis Mitra         
Sponsors and Collaborators
Michigan State University
Pfizer
Investigators
Principal Investigator: Subhashis Mitra, M.D Michigan State University
  More Information

No publications provided

Responsible Party: Subhashis Mitra, Assistant Professor of Medicine, Michigan State University
ClinicalTrials.gov Identifier: NCT01974817     History of Changes
Other Study ID Numbers: WI170883
Study First Received: October 28, 2013
Last Updated: November 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Michigan State University:
pneumococcal vaccine
end stage renal disease
dialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on September 18, 2014