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Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease (IPS-BOOSTER)

Primary Purpose

Rheumatoid Arthritis, Systemic Lupus, Sjögren Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
13-valent pneumococcal conjugate vaccine
23-valent pneumococcal polysaccharide vaccine
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatoid Arthritis focused on measuring Pneumococcal Conjugate Vaccine, Pneumococcal Disease, Immune Response, Inflammatory Rheumatic Disease, Pneumococcal Polysaccharide Vaccine, Immunosuppression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult patients with IRD receiving active anti-rheumatic treatments with DMARDs or biological remedies are offered to participate in the study. The protocol permits stratification for prednisolone usage.

Exclusion Criteria:

  • known allergy/intolerance of pneumococcal vaccine
  • pregnancy
  • active infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    PCV13+PPV23 vaccinated patients

    PCV13+PPV23 vaccinated controls

    PPV23-booster to previous PCV-vaccinated patients

    PCV13 to previous PPV23-vaccinated patients

    PPV23-booster to previous PCV-vaccinated controls

    Arm Description

    Patients with different inflammatory rheumatic diseases are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.

    Healthy controls are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.

    Patients with different inflammatory rheumatic disease previously immunized with one dose PCV7 or PCV13 within another study (see VACCIMIL), are immunized with one dose PPV23 0.5 ml i.m.

    Patients with different inflammatory rheumatic disease previously immunized with one dose PPV23 within another study (see VACCIMIL), are immunized with one dose PCV13 0.5 ml i.m.

    Healthy controls previously immunized with one dose PCV7 or PCV13 within another study (see VACCIMIL), are immunized with one dose PPV23 0.5 ml i.m.

    Outcomes

    Primary Outcome Measures

    2-fold rise in pneumococcal serotype-specific antibody concentration
    Pneumococcal serotype-specific antibody concentration (12-valent)

    Secondary Outcome Measures

    Functional antibody response
    Opsonophagocytosis activity assay
    Long-term serotype-specific immunity to pneumococcal disease
    Pneumococcal serotype-specific antibody concentration

    Full Information

    First Posted
    December 3, 2018
    Last Updated
    March 28, 2023
    Sponsor
    Region Skane
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03762824
    Brief Title
    Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease
    Acronym
    IPS-BOOSTER
    Official Title
    Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    June 14, 2016 (Actual)
    Primary Completion Date
    September 3, 2018 (Actual)
    Study Completion Date
    December 21, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Region Skane

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on antibody response elicited by pneumococcal vaccination using 13-valent conjugate vaccine in combined schedules with 23-valent polysaccharide vaccine. In addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in immunosuppressed patients with IRD, impact on existing rheumatic disease, possible association with onset of new autoimmune diseases, long-term immunity following pneumococcal vaccination and efficacy in preventing invasive pneumococcal disease. Results from this study are expected to bridge the existing knowledge gap and contribute to body of evidence needed for recommendations and implementation of vaccination program in IRD patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis, Systemic Lupus, Sjögren Syndrome, Systemic Vasculitis, Spondyloarthritis
    Keywords
    Pneumococcal Conjugate Vaccine, Pneumococcal Disease, Immune Response, Inflammatory Rheumatic Disease, Pneumococcal Polysaccharide Vaccine, Immunosuppression

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    300 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PCV13+PPV23 vaccinated patients
    Arm Type
    Active Comparator
    Arm Description
    Patients with different inflammatory rheumatic diseases are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.
    Arm Title
    PCV13+PPV23 vaccinated controls
    Arm Type
    Active Comparator
    Arm Description
    Healthy controls are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.
    Arm Title
    PPV23-booster to previous PCV-vaccinated patients
    Arm Type
    Active Comparator
    Arm Description
    Patients with different inflammatory rheumatic disease previously immunized with one dose PCV7 or PCV13 within another study (see VACCIMIL), are immunized with one dose PPV23 0.5 ml i.m.
    Arm Title
    PCV13 to previous PPV23-vaccinated patients
    Arm Type
    Active Comparator
    Arm Description
    Patients with different inflammatory rheumatic disease previously immunized with one dose PPV23 within another study (see VACCIMIL), are immunized with one dose PCV13 0.5 ml i.m.
    Arm Title
    PPV23-booster to previous PCV-vaccinated controls
    Arm Type
    Active Comparator
    Arm Description
    Healthy controls previously immunized with one dose PCV7 or PCV13 within another study (see VACCIMIL), are immunized with one dose PPV23 0.5 ml i.m.
    Intervention Type
    Biological
    Intervention Name(s)
    13-valent pneumococcal conjugate vaccine
    Other Intervention Name(s)
    Prevenar 13, PCV13
    Intervention Description
    Pneumococcal conjugate vaccination during antirheumatic treatment
    Intervention Type
    Biological
    Intervention Name(s)
    23-valent pneumococcal polysaccharide vaccine
    Other Intervention Name(s)
    Pneumovax, PPV23
    Intervention Description
    Pneumococcal polysaccharide vaccination during antirheumatic treatment
    Primary Outcome Measure Information:
    Title
    2-fold rise in pneumococcal serotype-specific antibody concentration
    Description
    Pneumococcal serotype-specific antibody concentration (12-valent)
    Time Frame
    8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination
    Secondary Outcome Measure Information:
    Title
    Functional antibody response
    Description
    Opsonophagocytosis activity assay
    Time Frame
    8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination
    Title
    Long-term serotype-specific immunity to pneumococcal disease
    Description
    Pneumococcal serotype-specific antibody concentration
    Time Frame
    3 years after vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adult patients with IRD receiving active anti-rheumatic treatments with DMARDs or biological remedies are offered to participate in the study. The protocol permits stratification for prednisolone usage. Exclusion Criteria: known allergy/intolerance of pneumococcal vaccine pregnancy active infection
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jehns Martineus, MD
    Organizational Affiliation
    Skåne Universitets sjukhus, dept of rheumatology
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    If requested we will consider sharing unidentified individual patient data
    Citations:
    PubMed Identifier
    12355475
    Citation
    Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum. 2002 Sep;46(9):2287-93. doi: 10.1002/art.10524.
    Results Reference
    background
    PubMed Identifier
    16287919
    Citation
    Kapetanovic MC, Saxne T, Sjoholm A, Truedsson L, Jonsson G, Geborek P. Influence of methotrexate, TNF blockers and prednisolone on antibody responses to pneumococcal polysaccharide vaccine in patients with rheumatoid arthritis. Rheumatology (Oxford). 2006 Jan;45(1):106-11. doi: 10.1093/rheumatology/kei193. Epub 2005 Nov 15.
    Results Reference
    background
    PubMed Identifier
    21834061
    Citation
    Kapetanovic MC, Roseman C, Jonsson G, Truedsson L, Saxne T, Geborek P. Antibody response is reduced following vaccination with 7-valent conjugate pneumococcal vaccine in adult methotrexate-treated patients with established arthritis, but not those treated with tumor necrosis factor inhibitors. Arthritis Rheum. 2011 Dec;63(12):3723-32. doi: 10.1002/art.30580.
    Results Reference
    background
    PubMed Identifier
    28552512
    Citation
    Nived P, Nagel J, Saxne T, Geborek P, Jonsson G, Skattum L, Kapetanovic MC. Immune response to pneumococcal conjugate vaccine in patients with systemic vasculitis receiving standard of care therapy. Vaccine. 2017 Jun 22;35(29):3639-3646. doi: 10.1016/j.vaccine.2017.05.044. Epub 2017 May 25.
    Results Reference
    background
    PubMed Identifier
    23051612
    Citation
    Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2012 Oct 12;61(40):816-9.
    Results Reference
    background
    PubMed Identifier
    32087733
    Citation
    Nived P, Jonsson G, Settergren B, Einarsson J, Olofsson T, Jorgensen CS, Skattum L, Kapetanovic MC. Prime-boost vaccination strategy enhances immunogenicity compared to single pneumococcal conjugate vaccination in patients receiving conventional DMARDs, to some extent in abatacept but not in rituximab-treated patients. Arthritis Res Ther. 2020 Feb 22;22(1):36. doi: 10.1186/s13075-020-2124-3. Erratum In: Arthritis Res Ther. 2020 Jun 26;22(1):162.
    Results Reference
    derived

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    Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease

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