13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients

Study Overview
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Brief Summary
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To assess the immunogenicity of the PCV13 (13 valent pneumococcal conjugated vaccine) vaccine as compared to the PPV23 (23 valent pneumococcal polysaccharide vaccine) vaccine in patients treated with chronic hemodialysis that are pre-immunized with the PPSV23 vaccine or are PPV23 vaccine naïve by measuring the ELISA and OPA (opsonophagocytic assay) titers after 4 and 52 weeks.

Detailed Description
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The immunogenicity of the PCV13 (13 valent pneumococcal conjugated vaccine) vaccine as compared to the PPV23 (23 valent pneumococcal polysaccharide vaccine) vaccine in patients treated with chronic hemodialysis that are pre-immunized with the PPV23 vaccine or are PPV23 vaccine naïve will be measured by ELISA and OPA (opsonophagocytic assay) titers after 4 and 52 weeks.

Official Title
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Immunogenicity and Safety of the 13-valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients That Are 23-valent Pneumococcal Polysaccharide Vaccine Naive and Pre-immunized.

Conditions
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Chronic Kidney Failure

Intervention / Treatment
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* Biological: PPV23 vaccination or PCV13 vaccination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: they are under chronic dialysis treatment are 50 years or older and not pregnant have no immediate life threatening conditions are not allergic to one of the compounds of the vaccine have a known pneumococcal vaccination status give their informed consent. Exclusion Criteria: Patients not fulfilling the inclusion criteria.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PPV23 naive, PPV23 vaccination<br>vaccination with PPV-23 in 40 PPV-23 naive patients | Biological: PPV23 vaccination or PCV13 vaccination<br> <br> * Other names: Pneumovac 23;|
| Experimental: PPV23 naive, PCV13 vaccination<br>vaccination with PCV-13 in 40 PPV-23 naive patients | Biological: PPV23 vaccination or PCV13 vaccination<br> <br> * Other names: Pneumovac 23;|
| Experimental: PPV23 > 4 years ago, PCV13 vaccination<br>vaccination with PCV-13 in 40 patients that received PPV-23 more than 4 years ago | Biological: PPV23 vaccination or PCV13 vaccination<br> <br> * Other names: Pneumovac 23;|
| Experimental: PPV23 < 4 years, PCV13 vaccination<br>vaccination with PCV-13 in 40 patients that received PPV-23 less than 4 years ago | Biological: PPV23 vaccination or PCV13 vaccination<br> <br> * Other names: Pneumovac 23;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response after vaccination to involved serotypes measured by OPA and ELISA |  | 52 weeks after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| record of side effects of vaccination |  | first week after vaccination | 
| Antibody response after vaccination to involved serotypes measured by OPA and ELISA |  | 4 weeks after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dialysis, pneumococcal vaccination, immune response