Back to results13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients
Primary Purpose
Chronic Kidney Failure
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
PPV23 vaccination or PCV13 vaccination
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Failure focused on measuring pneumococcal vaccination, dialysis, immune response
Eligibility Criteria
Inclusion Criteria:
- they are under chronic dialysis treatment
- are 50 years or older and not pregnant
- have no immediate life threatening conditions
- are not allergic to one of the compounds of the vaccine
- have a known pneumococcal vaccination status
- give their informed consent.
Exclusion Criteria:
Patients not fulfilling the inclusion criteria.
Sites / Locations
- Dienst Nefrologie, OLV Ziekenhuis
- AZ Sint-Jan Brugge Oostende AV
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
PPV23 naive, PPV23 vaccination
PPV23 naive, PCV13 vaccination
PPV23 > 4 years ago, PCV13 vaccination
PPV23 < 4 years, PCV13 vaccination
Arm Description
vaccination with PPV-23 in 40 PPV-23 naive patients
vaccination with PCV-13 in 40 PPV-23 naive patients
vaccination with PCV-13 in 40 patients that received PPV-23 more than 4 years ago
vaccination with PCV-13 in 40 patients that received PPV-23 less than 4 years ago
Outcomes
Primary Outcome Measures
Antibody response after vaccination to involved serotypes measured by OPA and ELISA
Secondary Outcome Measures
record of side effects of vaccination
Antibody response after vaccination to involved serotypes measured by OPA and ELISA
Full Information
NCT ID
NCT02492438
First Posted
August 24, 2014
Last Updated
July 5, 2015
Sponsor
AZ Sint-Jan AV
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT02492438
Brief Title
13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AZ Sint-Jan AV
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Failure
Keywords
pneumococcal vaccination, dialysis, immune response
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PPV23 naive, PPV23 vaccination
Arm Type
Active Comparator
Arm Description
vaccination with PPV-23 in 40 PPV-23 naive patients
Arm Title
PPV23 naive, PCV13 vaccination
Arm Type
Experimental
Arm Description
vaccination with PCV-13 in 40 PPV-23 naive patients
Arm Title
PPV23 > 4 years ago, PCV13 vaccination
Arm Type
Experimental
Arm Description
vaccination with PCV-13 in 40 patients that received PPV-23 more than 4 years ago
Arm Title
PPV23 < 4 years, PCV13 vaccination
Arm Type
Experimental
Arm Description
vaccination with PCV-13 in 40 patients that received PPV-23 less than 4 years ago
Intervention Type
Biological
Intervention Name(s)
PPV23 vaccination or PCV13 vaccination
Other Intervention Name(s)
Prevenar 13, Pneumovac 23
Primary Outcome Measure Information:
Title
Antibody response after vaccination to involved serotypes measured by OPA and ELISA
Time Frame
52 weeks after vaccination
Secondary Outcome Measure Information:
Title
record of side effects of vaccination
Time Frame
first week after vaccination
Title
Antibody response after vaccination to involved serotypes measured by OPA and ELISA
Time Frame
4 weeks after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
they are under chronic dialysis treatment
are 50 years or older and not pregnant
have no immediate life threatening conditions
are not allergic to one of the compounds of the vaccine
have a known pneumococcal vaccination status
give their informed consent.
Exclusion Criteria:
Patients not fulfilling the inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefaan J Vandecasteele, MD, PhD
Organizational Affiliation
Department of Nephrology and Infectious Diseases, AZ Sint-Jan Brugge, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dienst Nefrologie, OLV Ziekenhuis
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
AZ Sint-Jan Brugge Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients
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