Clinical trial NCT01974817: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: End Stage Renal Disease
Keywords: pneumococcal vaccine
end stage renal disease
dialysis
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2013-11-03
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lansing
country: United States
facility: Sparrow Dialysis at Saint Lawrence Campus
state: Michigan
Study officials:
affiliation: Michigan State University
name: Subhashis Mitra, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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.