The Effect of Previous Pneumococcal Immunization on the Immune Response of Patients With Severe CKD to Prevnar 13

NCT02370069 | Completed Phase 4

• 1 other identifier: RP-232-08262014
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• 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

  0 days, 28 days

• immunogenicity (Increase in OPA titres 28 days post-immunization)

  Increase in OPA titres 28 days post-immunization

  28 days

Secondary Outcomes (3)

• Longevity of the immune response (Persistence of antibody one year post-immunization)

  365 days

• Longevity of the immune response (Persistence of OPA titres one year post-immunization)

  365 days

• Clinical effect (Number of all infectious episodes during one year post-immunization)

  365 days

Study Arms (2)

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.

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.

Biological: Prevnar 13

Interventions

Prevnar 13 BIOLOGICAL

One dose of 0.5 mL Prevnar 13 injected intramuscularly into the deltoid muscle on Day 0.

Naive to PPV23; Previous immunization with PPV23

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females of 18 years of age or older at the time of the vaccination
• Severe chronic kidney disease (Stage 4 and 5)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lakehead University: lead

Study Sites (1)

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Related Publications (3)

• 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.

  PMID: 33358702 BACKGROUND

• 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.

  PMID: 35738971 DERIVED

• 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.

  PMID: 31718534 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marina Ulanova, MD, PhD

  Lakehead University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Medical Sciences

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: February 24, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)