13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients

July 5, 2015 updated by: Vandecasteele Stefaan Johan, AZ Sint-Jan AV

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Dienst Nefrologie, OLV Ziekenhuis
      • Brugge, Belgium, 8000
        • AZ Sint-Jan Brugge Oostende AV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AZ Sint-Jan AV

Collaborators

Pfizer

Investigators

  • Principal Investigator: Stefaan J Vandecasteele, MD, PhD, Department of Nephrology and Infectious Diseases, AZ Sint-Jan Brugge, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 24, 2014

First Submitted That Met QC Criteria

July 5, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Estimate)

July 8, 2015

Last Update Submitted That Met QC Criteria

July 5, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS2113445

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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