13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients

AZ Sint-Jan AV

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Failure

Treatments: Biological: PPV23 vaccination or PCV13 vaccination

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02492438

WS2113445

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 4 patient groups

PPV23 naive, PPV23 vaccination

Active Comparator group

Description:

vaccination with PPV-23 in 40 PPV-23 naive patients

Treatment:

Biological: PPV23 vaccination or PCV13 vaccination

PPV23 naive, PCV13 vaccination

Experimental group

Description:

vaccination with PCV-13 in 40 PPV-23 naive patients

Treatment:

Biological: PPV23 vaccination or PCV13 vaccination

PPV23 > 4 years ago, PCV13 vaccination

Experimental group

Description:

vaccination with PCV-13 in 40 patients that received PPV-23 more than 4 years ago

Treatment:

Biological: PPV23 vaccination or PCV13 vaccination

PPV23 < 4 years, PCV13 vaccination

Experimental group

Description:

vaccination with PCV-13 in 40 patients that received PPV-23 less than 4 years ago

Treatment:

Biological: PPV23 vaccination or PCV13 vaccination