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

Michigan State University

Status and phase: Completed; Phase 4

Conditions: End Stage Renal Disease

Treatments: Biological: 13-valent conjugate pneumococcal vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01974817

WI170883

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Vaccine

Experimental group

Description:

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

Treatment:

Biological: 13-valent conjugate pneumococcal vaccine