Chronic Kidney FailurePhase 4NCT02492438
13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients
A Phase 4 study testing PPV23 vaccination or PCV13 vaccination in people with Chronic Kidney Failure, run by AZ Sint-Jan AV at 2 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- PPV23 vaccination or PCV13 vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesBelgium
- Study dates
- Feb 2013to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients not fulfilling the inclusion criteria.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Dienst Nefrologie, OLV Ziekenhuis
Aalst, 9300
AZ Sint-Jan Brugge Oostende AV
Bruges, 8000
About this study
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.
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.
Read the 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.
- Conditions
- Chronic Kidney Failure
- Being tested
- PPV23 vaccination or PCV13 vaccination
- Keywords
- pneumococcal vaccination, dialysis, immune response
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPV23 vaccination or PCV13 vaccinationBiological
Also called Prevenar 13, Pneumovac 23
| Study group | Role | What they receive |
|---|---|---|
| PPV23 naive, PPV23 vaccination | Active comparator | vaccination with PPV-23 in 40 PPV-23 naive patients Receives: Biological: PPV23 vaccination or PCV13 vaccination |
| PPV23 naive, PCV13 vaccination | Experimental | vaccination with PCV-13 in 40 PPV-23 naive patients Receives: Biological: PPV23 vaccination or PCV13 vaccination |
| PPV23 > 4 years ago, PCV13 vaccination | Experimental | vaccination with PCV-13 in 40 patients that received PPV-23 more than 4 years ago Receives: Biological: PPV23 vaccination or PCV13 vaccination |
| PPV23 < 4 years, PCV13 vaccination | Experimental | vaccination with PCV-13 in 40 patients that received PPV-23 less than 4 years ago Receives: Biological: PPV23 vaccination or PCV13 vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response after vaccination to involved serotypes measured by OPA and ELISA
Measured: 52 weeks after vaccination
Secondary outcomes (2)
record of side effects of vaccination
Measured: first week after vaccination
Antibody response after vaccination to involved serotypes measured by OPA and ELISA
Measured: 4 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Vandecasteele Stefaan Johan, AZ Sint-Jan AV
- Investigators
- Stefaan J Vandecasteele, MD, PhD, Principal investigator, Department of Nephrology and Infectious Diseases, AZ Sint-Jan Brugge, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492438
- Sponsor's protocol ID
- WS2113445
- Status last verified
- Jul 2015
- First submitted
- 24 Aug 2014
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02492438
- Acronym / sponsor ID
- WS2113445
- Conditions
- Chronic Kidney Failure
- Keywords
- pneumococcal vaccination, dialysis, immune response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PPV23 naive, PPV23 vaccination | Active comparator | Biological: PPV23 vaccination or PCV13 vaccinationvaccination with PPV-23 in 40 PPV-23 naive patients |
| PPV23 naive, PCV13 vaccination | Experimental | Biological: PPV23 vaccination or PCV13 vaccinationvaccination with PCV-13 in 40 PPV-23 naive patients |
| PPV23 > 4 years ago, PCV13 vaccination | Experimental | Biological: PPV23 vaccination or PCV13 vaccinationvaccination with PCV-13 in 40 patients that received PPV-23 more than 4 years ago |
| PPV23 < 4 years, PCV13 vaccination | Experimental | Biological: PPV23 vaccination or PCV13 vaccinationvaccination with PCV-13 in 40 patients that received PPV-23 less than 4 years ago |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Patients not fulfilling the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPV23 vaccination or PCV13 vaccinationAlso: Prevenar 13, Pneumovac 23 | Biological | PPV23 < 4 years, PCV13 vaccination, PPV23 > 4 years ago, PCV13 vaccination, PPV23 naive, PCV13 vaccination, PPV23 naive, PPV23 vaccination |
Primary outcome
Antibody response after vaccination to involved serotypes measured by OPA and ELISA
Time frame: 52 weeks after vaccination
2 secondary outcomes
record of side effects of vaccination
Time frame: first week after vaccination
Antibody response after vaccination to involved serotypes measured by OPA and ELISA
Time frame: 4 weeks after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefaan J Vandecasteele, MD, PhD principal investigator
Department of Nephrology and Infectious Diseases, AZ Sint-Jan Brugge, Belgium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PPV23 vaccination or PCV13 vaccination in people with Chronic Kidney Failure, run by AZ Sint-Jan AV at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody response after vaccination to involved serotypes measured by OPA and ELISA (time frame: 52 weeks after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015.