Chronic Kidney DiseasesPhase 4NCT02370069
The Effect of Previous Pneumococcal Immunization on the Immune Response of Patients With Severe CKD to Prevnar 13
A Phase 4 study testing Prevnar 13 in people with Chronic Kidney Diseases, run by Lakehead University at 1 site in Canada.
Trial summary
Patients with severe chronic kidney disease (CKD) are at a great risk for infection due to their immune system being suppressed. Pneumococcal infection is particularly common and often results in death due to inflammation of lung (pneumonia) or the whole body (sepsis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Prevnar 13
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Aug 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females of 18 years of age or older at the time of the vaccination
- Severe chronic kidney disease (Stage 4 and 5)
Who cannot join
- immunization with PPV23 within the last year
- any confirmed or suspected immunodeficiency condition, including human immunodeficiency virus (HIV) infection, haematological malignancy, or a congenital immunodeficiency
- history of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- history of allergic disease likely to be stimulated by the vaccination
- history or records of immunosuppressive therapy (with the exception of topical corticosteroids) for more than 14 days and within 6 months of vaccination
- history or evidence of administration of immunoglobulins and/or any blood products during the study period or within the three months preceding the study vaccine
Show all 9Show fewer
- use of any other investigational or non-registered drug or vaccine during the study period or within 30 days preceding the study vaccine
- administration of a vaccine during the period starting one month before the dose of vaccine and ending one month after
- pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
About this study
Official title: The Effect of Previous Pneumococcal Immunization on the Immune Response of Adult Patients With Severe Chronic Kidney Disease to Prevnar 13
Patients with severe chronic kidney disease (CKD) are at a great risk for infection due to their immune system being suppressed. Pneumococcal infection is particularly common and often results in death due to inflammation of lung (pneumonia) or the whole body (sepsis). This infection can be prevented using vaccines which help build protective immunity. The currently recommended pneumococcal vaccine (Pneumovax), however, is often inefficient in this group of patients. There is thus an urgent need to improve the existing vaccination policy.
The goal of this research is to optimize pneumococcal vaccination of patients with severe CKD. Many patients suffering from CKD have already been vaccinated with Pneumovax. Because this vaccine has low immunogenicity in immunocompromised individuals, they may still develop infection. A new vaccine, Prevnar13, has superior immunogenicity and has been recently approved for immunization. There is, however, no specific policy regarding immunization of adult CKD patients, and it is furthermore unknown whether previous Pneumovax immunization negatively affects immune response to Prevnar13.
Read more
In order to test whether previous immunization with Pneumovax affects the immune response of severe CKD patients to Prevnar 13, the investigators will immunize two groups of adult stage 4 and 5 CKD patients with one dose of Prevnar 13 and will assess their initial immunological response, its longevity, and vaccine safety. The first group will consist of patients who had been previously immunized with Pneumovax, and the second group will include participants with no history of pneumococcal vaccination.
Antibody levels and opsonophagocytic activity (OPA) will be quantified. The longevity of the immune response will be assessed. As a secondary objective, the immune response will be analyzed in the context of demographic and clinical characteristics of the vaccinated participants.
Read the detailed description
Adult patients with severe chronic kidney disease (CKD) are immunocompromised and known to have an increased risk of pneumococcal infection. To prevent the infection, immunization with pneumococcal polysaccharide vaccine (PPV23) is currently recommended in Canada; however, the vaccine effect in these patients is suboptimal because of their immune dysfunction. The second-generation pneumococcal vaccines (polysaccharide-protein conjugate) have superior immunogenicity in some immunocompromised adult individuals. In Canada, Prevnar 13 has recently been recommended by the NACI for certain categories of immunocompromised adults, such as HSCT recipients and HIV-positive patients. However, the NACI has concluded that there is currently insufficient evidence to recommend the use of Prevnar 13 in patients with chronic kidney disease. No published data on the use of pneumococcal conjugate vaccines in adults with CKD are available. Moreover, it is unknown whether a previous immunization with PPV23 may have a negative effect on the immune response to Prevnar 13 in these patients. Such a possibility exists due to the memory B-cells' depletion following immunization with pure polysaccharide antigens. In this case, additional doses of Prevnar 13 may be required to achieve the optimal protection. The conjugate vaccine will then expand the B-cell pool available to respond to subsequent antigen challenge. To test whether previous immunization with PPV23 affects the immune response of severe CKD patients to Prevnar 13, we will immunize two groups of adult stage 4 and 5 CKD patients attending the Thunder Bay Regional Health Sciences Centre with one dose of Prevnar 13 and will assess their initial immunological response, its longevity, and vaccine safety. The first group will consist of patients who had been immunized with PPV23 more than one year prior to the enrollment in this study and the second group will include patients without history of pneumococcal vaccination. Fold increase in antibody levels and OPA, as well as longevity of the immune response over a one-year period will be assessed as the surrogate for protection against pneumococcal infection. The immune response will be analyzed in the context of demographic and clinical characteristics of the vaccinated patients. All infectious episodes in the study participants will be recorded throughout one year of observation. We will also record all vaccine adverse effects following immunization and compare their frequency and severity between the two groups. The anticipated results of this trial will provide essential evidence to justify the use of Prevnar 13 for immunization of adult CKD patients.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Prevnar 13
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevnar 13Biological
One dose of 0.5 mL Prevnar 13 injected intramuscularly into the deltoid muscle on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Previous immunization with PPV23 | Active comparator | Participants who have received a previous vaccination with 1 or more dose of PPV23 at least 12 months previously will receive one dose of 0.5 mL Prevnar 13 study vaccine. Receives: Biological: Prevnar 13 |
| Naive to PPV23 | Active comparator | Participants who have never received a previous vaccination with PPV23 will receive one dose of 0.5 mL Prevnar 13 study vaccine. Receives: Biological: Prevnar 13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunogenicity (Fold increase in serotype-specific antibody levels 28 days post-immunization as compared to baseline)
Fold increase in serotype-specific antibody levels 28 days post-immunization as compared to baseline
Measured: 0 days, 28 days
immunogenicity (Increase in OPA titres 28 days post-immunization)
Increase in OPA titres 28 days post-immunization
Measured: 28 days
Secondary outcomes (3)
Longevity of the immune response (Persistence of antibody one year post-immunization)
Persistence of antibody one year post-immunization
Measured: 365 days
Longevity of the immune response (Persistence of OPA titres one year post-immunization)
Persistence of OPA titres one year post-immunization
Measured: 365 days
Clinical effect (Number of all infectious episodes during one year post-immunization)
Number of all infectious episodes during one year post-immunization
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakehead University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Ulanova, Lakehead University
- Investigators
- Marina Ulanova, MD, PhD, Principal investigator, Lakehead University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370069
- Sponsor's protocol ID
- RP-232-08262014
- Status last verified
- Sep 2021
- First submitted
- 18 Feb 2015
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ulanova M, Huska B, Desbiens A, Gaultier GN, Domonkos V, McCready WG. Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in 23-valent pneumococcal polysaccharide vaccine-naive and previously immunized adult patients with severe chronic kidney disease. Vaccine. 2021 Jan 22;39(4):699-710. doi: 10.1016/j.vaccine.2020.12.035. Epub 2020 Dec 24.
PubMed 33358702Ulanova M, Huska B, Dubois S, McCready W. Opsonophagocytic activity against Streptococcus pneumoniae in Indigenous and non-Indigenous patients with severe chronic kidney disease immunized with 13-valent pneumococcal conjugate vaccine. Vaccine. 2022 Jul 30;40(32):4594-4602. doi: 10.1016/j.vaccine.2022.06.042. Epub 2022 Jun 21.
PubMed 35738971Gaultier GN, McCready W, Ulanova M. The effect of pneumococcal immunization on total and antigen-specific B cells in patients with severe chronic kidney disease. BMC Immunol. 2019 Nov 12;20(1):41. doi: 10.1186/s12865-019-0325-9.
PubMed 31718534
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Previous Pneumococcal Immunization on the Immune Response of Adult Patients With Severe Chronic Kidney Disease to Prevnar 13
- ClinicalTrials.gov ID
- NCT02370069
- Acronym / sponsor ID
- RP-232-08262014
- Conditions
- Chronic Kidney Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Lakehead UniversityUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 24 Feb 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.
Patients with severe chronic kidney disease (CKD) are at a great risk for infection due to their immune system being suppressed. Pneumococcal infection is particularly common and often results in death due to inflammation of lung (pneumonia) or the whole body (sepsis). This infection can be prevented using vaccines which help build protective immunity. The currently recommended pneumococcal vaccine (Pneumovax), however, is often inefficient in this group of patients. There is thus an urgent need to improve the existing vaccination policy.
The goal of this research is to optimize pneumococcal vaccination of patients with severe CKD. Many patients suffering from CKD have already been vaccinated with Pneumovax. Because this vaccine has low immunogenicity in immunocompromised individuals, they may still develop infection. A new vaccine, Prevnar13, has superior immunogenicity and has been recently approved for immunization. There is, however, no specific policy regarding immunization of adult CKD patients, and it is furthermore unknown whether previous Pneumovax immunization negatively affects immune response to Prevnar13.
In order to test whether previous immunization with Pneumovax affects the immune response of severe CKD patients to Prevnar 13, the investigators will immunize two groups of adult stage 4 and 5 CKD patients with one dose of Prevnar 13 and will assess their initial immunological response, its longevity, and vaccine safety. The first group will consist of patients who had been previously immunized with Pneumovax, and the second group will include participants with no history of pneumococcal vaccination.
Antibody levels and opsonophagocytic activity (OPA) will be quantified. The longevity of the immune response will be assessed. As a secondary objective, the immune response will be analyzed in the context of demographic and clinical characteristics of the vaccinated participants.
Detailed description
Adult patients with severe chronic kidney disease (CKD) are immunocompromised and known to have an increased risk of pneumococcal infection. To prevent the infection, immunization with pneumococcal polysaccharide vaccine (PPV23) is currently recommended in Canada; however, the vaccine effect in these patients is suboptimal because of their immune dysfunction. The second-generation pneumococcal vaccines (polysaccharide-protein conjugate) have superior immunogenicity in some immunocompromised adult individuals. In Canada, Prevnar 13 has recently been recommended by the NACI for certain categories of immunocompromised adults, such as HSCT recipients and HIV-positive patients. However, the NACI has concluded that there is currently insufficient evidence to recommend the use of Prevnar 13 in patients with chronic kidney disease. No published data on the use of pneumococcal conjugate vaccines in adults with CKD are available. Moreover, it is unknown whether a previous immunization with PPV23 may have a negative effect on the immune response to Prevnar 13 in these patients. Such a possibility exists due to the memory B-cells' depletion following immunization with pure polysaccharide antigens. In this case, additional doses of Prevnar 13 may be required to achieve the optimal protection. The conjugate vaccine will then expand the B-cell pool available to respond to subsequent antigen challenge. To test whether previous immunization with PPV23 affects the immune response of severe CKD patients to Prevnar 13, we will immunize two groups of adult stage 4 and 5 CKD patients attending the Thunder Bay Regional Health Sciences Centre with one dose of Prevnar 13 and will assess their initial immunological response, its longevity, and vaccine safety. The first group will consist of patients who had been immunized with PPV23 more than one year prior to the enrollment in this study and the second group will include patients without history of pneumococcal vaccination. Fold increase in antibody levels and OPA, as well as longevity of the immune response over a one-year period will be assessed as the surrogate for protection against pneumococcal infection. The immune response will be analyzed in the context of demographic and clinical characteristics of the vaccinated patients. All infectious episodes in the study participants will be recorded throughout one year of observation. We will also record all vaccine adverse effects following immunization and compare their frequency and severity between the two groups. The anticipated results of this trial will provide essential evidence to justify the use of Prevnar 13 for immunization of adult CKD patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previous immunization with PPV23 | Active comparator | Biological: Prevnar 13Participants who have received a previous vaccination with 1 or more dose of PPV23 at least 12 months previously will receive one dose of 0.5 mL Prevnar 13 study vaccine. |
| Naive to PPV23 | Active comparator | Biological: Prevnar 13Participants who have never received a previous vaccination with PPV23 will receive one dose of 0.5 mL Prevnar 13 study vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females of 18 years of age or older at the time of the vaccination
- Severe chronic kidney disease (Stage 4 and 5)
Key exclusion criteria (9 listed)
- immunization with PPV23 within the last year
- any confirmed or suspected immunodeficiency condition, including human immunodeficiency virus (HIV) infection, haematological malignancy, or a congenital immunodeficiency
- history of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- history of allergic disease likely to be stimulated by the vaccination
- history or records of immunosuppressive therapy (with the exception of topical corticosteroids) for more than 14 days and within 6 months of vaccination
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 |
|---|---|---|
| Prevnar 13One dose of 0.5 mL Prevnar 13 injected intramuscularly into the deltoid muscle on Day 0. | Biological | Naive to PPV23, Previous immunization with PPV23 |
Primary outcome
immunogenicity (Fold increase in serotype-specific antibody levels 28 days post-immunization as compared to baseline)
Time frame: 0 days, 28 days
Fold increase in serotype-specific antibody levels 28 days post-immunization as compared to baseline
immunogenicity (Increase in OPA titres 28 days post-immunization)
Time frame: 28 days
Increase in OPA titres 28 days post-immunization
3 secondary outcomes
Longevity of the immune response (Persistence of antibody one year post-immunization)
Time frame: 365 days
Longevity of the immune response (Persistence of OPA titres one year post-immunization)
Time frame: 365 days
Clinical effect (Number of all infectious episodes during one year post-immunization)
Time frame: 365 days
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 9 Sep 2021.
- Background: PubMed 33358702Ulanova M, Huska B, Desbiens A, Gaultier GN, Domonkos V, McCready WG. Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in 23-valent pneumococcal polysaccharide vaccine-naive and previously immunized adult patients with severe chronic kidney disease. Vaccine. 2021 Jan 22;39(4):699-710. doi: 10.1016/j.vaccine.2020.12.035. Epub 2020 Dec 24.
- Derived from this study: PubMed 35738971Ulanova M, Huska B, Dubois S, McCready W. Opsonophagocytic activity against Streptococcus pneumoniae in Indigenous and non-Indigenous patients with severe chronic kidney disease immunized with 13-valent pneumococcal conjugate vaccine. Vaccine. 2022 Jul 30;40(32):4594-4602. doi: 10.1016/j.vaccine.2022.06.042. Epub 2022 Jun 21.
- Derived from this study: PubMed 31718534Gaultier GN, McCready W, Ulanova M. The effect of pneumococcal immunization on total and antigen-specific B cells in patients with severe chronic kidney disease. BMC Immunol. 2019 Nov 12;20(1):41. doi: 10.1186/s12865-019-0325-9.
- Individual participant dataSharing planned: No
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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.
Marina Ulanova, MD, PhD principal investigator
Lakehead University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prevnar 13 in people with Chronic Kidney Diseases, run by Lakehead University at 1 site in Canada.
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 2 inclusion and 9 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 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
immunogenicity (Fold increase in serotype-specific antibody levels 28 days post-immunization as compared to baseline) (time frame: 0 days, 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02370069, which also lists 3 linked publications.
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 9 Sep 2021.