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13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients

NCT02492438 — Phase 4, Completed, 154 participants, AZ Sint-Jan AV
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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.

RegistryNCT02492438
StatusCompleted
PhasePhase 4
Study typeInterventional; non randomized, parallel, masking: none, prevention
Enrollment154 (Actual)
SponsorAZ Sint-Jan AV (Other); collaborators: Pfizer
ConditionsChronic Kidney Failure
InterventionsPPV23 vaccination or PCV13 vaccination (Biological)
Datesstart 2013-02-01, primary completion 2014-02-01, completion 2014-03-01, first posted 2015-07-08, last updated 2015-07-08
Locations2 sites in Belgium

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
PPV23 naive, PPV23 vaccinationActive comparatorBiological: PPV23 vaccination or PCV13 vaccinationvaccination with PPV-23 in 40 PPV-23 naive patients
PPV23 naive, PCV13 vaccinationExperimentalBiological: PPV23 vaccination or PCV13 vaccinationvaccination with PCV-13 in 40 PPV-23 naive patients
PPV23 > 4 years ago, PCV13 vaccinationExperimentalBiological: PPV23 vaccination or PCV13 vaccinationvaccination with PCV-13 in 40 patients that received PPV-23 more than 4 years ago
PPV23 < 4 years, PCV13 vaccinationExperimentalBiological: PPV23 vaccination or PCV13 vaccinationvaccination with PCV-13 in 40 patients that received PPV-23 less than 4 years ago
  • PPV23 vaccination or PCV13 vaccination (Biological), also known as Prevenar 13, Pneumovac 23

+Outcome measures

Primary outcomes

  • Antibody response after vaccination to involved serotypes measured by OPA and ELISA [52 weeks after vaccination]

Secondary outcomes

  • 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]

+Eligibility

Sex: All, ages: 50 Years to any

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.

+Locations (2)

FacilityCityCountryStatus
Dienst Nefrologie, OLV ZiekenhuisAalstBelgium
AZ Sint-Jan Brugge Oostende AVBrugesBelgium

+Investigators

My Notes