Chronic Kidney Failure
Conditions
Keywords
pneumococcal vaccination, dialysis, immune response
Brief summary
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
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.
Interventions
BIOLOGICALPPV23 vaccination or PCV13 vaccination
Sponsors
Pfizer
AZ Sint-Jan AV
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. they are under chronic dialysis treatment 2. are 50 years or older and not pregnant 3. have no immediate life threatening conditions 4. are not allergic to one of the compounds of the vaccine 5. have a known pneumococcal vaccination status 6. give their informed consent.
Exclusion criteria
Patients not fulfilling the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody response after vaccination to involved serotypes measured by OPA and ELISA | 52 weeks after vaccination |
Secondary
| Measure | 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 |
Countries
Belgium
Outcome results
None listed