- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02370069
The Effect of Previous Pneumococcal Immunization on the Immune Response of Patients With Severe CKD to Prevnar 13
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.
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Ontario
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Thunder Bay, Ontario, Canada, P7B 6V4
- Thunder Bay Regional Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males and females of 18 years of age or older at the time of the vaccination
- Severe chronic kidney disease (Stage 4 and 5)
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Previous immunization with PPV23
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.
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One dose of 0.5 mL Prevnar 13 injected intramuscularly into the deltoid muscle on Day 0.
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Active Comparator: Naive to PPV23
Participants who have never received a previous vaccination with PPV23 will receive one dose of 0.5 mL Prevnar 13 study vaccine.
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One dose of 0.5 mL Prevnar 13 injected intramuscularly into the deltoid muscle on Day 0.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
immunogenicity (Fold increase in serotype-specific antibody levels 28 days post-immunization as compared to baseline)
Time Frame: 0 days, 28 days
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Fold increase in serotype-specific antibody levels 28 days post-immunization as compared to baseline
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0 days, 28 days
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immunogenicity (Increase in OPA titres 28 days post-immunization)
Time Frame: 28 days
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Increase in OPA titres 28 days post-immunization
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Longevity of the immune response (Persistence of antibody one year post-immunization)
Time Frame: 365 days
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Persistence of antibody one year post-immunization
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365 days
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Longevity of the immune response (Persistence of OPA titres one year post-immunization)
Time Frame: 365 days
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Persistence of OPA titres one year post-immunization
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365 days
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Clinical effect (Number of all infectious episodes during one year post-immunization)
Time Frame: 365 days
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Number of all infectious episodes during one year post-immunization
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365 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marina Ulanova, MD, PhD, Lakehead University
Publications and helpful links
General 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.
- Ulanova 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.
- Gaultier 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RP-232-08262014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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