13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients

Phase 4

Completed

• Conditions: Chronic Kidney Failure
• Interventions: Biological: PPV23 vaccination or PCV13 vaccination

• Registration Number: NCT02492438
• Lead Sponsor: AZ Sint-Jan AV

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.

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2014-02
• Study Completion: 2014-03
• Study First Submitted: 2014-08-24
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-05
• Last Update Submitted: 2015-07-05
• Study First Posted: 2015-07-08
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPV23 naive, PCV13 vaccination	PPV23 vaccination or PCV13 vaccination	vaccination with PCV-13 in 40 PPV-23 naive patients
PPV23 naive, PPV23 vaccination	PPV23 vaccination or PCV13 vaccination	vaccination with PPV-23 in 40 PPV-23 naive patients
PPV23 > 4 years ago, PCV13 vaccination	PPV23 vaccination or PCV13 vaccination	vaccination with PCV-13 in 40 patients that received PPV-23 more than 4 years ago
PPV23 < 4 years, PCV13 vaccination	PPV23 vaccination or PCV13 vaccination	vaccination with PCV-13 in 40 patients that received PPV-23 less than 4 years ago

Primary Outcome Measures

Name	Time	Method
Antibody response after vaccination to involved serotypes measured by OPA and ELISA	52 weeks after vaccination

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Dienst Nefrologie, OLV Ziekenhuis; 🇧🇪 Aalst, Belgium

AZ Sint-Jan Brugge Oostende AV; 🇧🇪 Brugge, Belgium