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Rheumatoid ArthritisPhase 4IPS-BOOSTERNCT03762824

Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease

A Phase 4 study testing 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in people with Rheumatoid Arthritis and Systemic Lupus, run by Region Skane.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
No sites listed yet
Study dates
14 Jun 2016to 21 Dec 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

About this study

Official title: Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response.

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.

Being tested
13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine
Keywords
Pneumococcal Conjugate Vaccine, Pneumococcal Disease, Immune Response, Inflammatory Rheumatic Disease, Pneumococcal Polysaccharide Vaccine, Immunosuppression
Medical subject headings
Arthritis, Rheumatoid, Sjogren's Syndrome, Systemic Vasculitis, Spondylarthritis, Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 13-valent pneumococcal conjugate vaccineBiological

    Also called Prevenar 13, PCV13

    Pneumococcal conjugate vaccination during antirheumatic treatment

  • 23-valent pneumococcal polysaccharide vaccineBiological

    Also called Pneumovax, PPV23

    Pneumococcal polysaccharide vaccination during antirheumatic treatment

Study groups in NCT03762824
Study groupRoleWhat they receive
PCV13+PPV23 vaccinated patientsActive comparatorPatients 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.
Receives: Biological: 13-valent pneumococcal conjugate vaccine; Biological: 23-valent pneumococcal polysaccharide vaccine
PCV13+PPV23 vaccinated controlsActive comparatorHealthy 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.
Receives: Biological: 13-valent pneumococcal conjugate vaccine; Biological: 23-valent pneumococcal polysaccharide vaccine
PPV23-booster to previous PCV-vaccinated patientsActive comparatorPatients 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.
Receives: Biological: 23-valent pneumococcal polysaccharide vaccine
PCV13 to previous PPV23-vaccinated patientsActive comparatorPatients 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.
Receives: Biological: 13-valent pneumococcal conjugate vaccine
PPV23-booster to previous PCV-vaccinated controlsActive comparatorHealthy 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.
Receives: Biological: 23-valent pneumococcal polysaccharide vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-fold rise in pneumococcal serotype-specific antibody concentration

    Pneumococcal serotype-specific antibody concentration (12-valent)

    Measured: 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination

Secondary outcomes (2)

  1. Functional antibody response

    Opsonophagocytosis activity assay

    Measured: 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination

  2. Long-term serotype-specific immunity to pneumococcal disease

    Pneumococcal serotype-specific antibody concentration

    Measured: 3 years after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2018
  2. Study start14 Jun 2016
  3. Primary completion3 Sep 2018
  4. Study completion21 Dec 2020

Resources

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
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03762824
Sponsor's protocol ID
IPS-BOOSTER
Acronym
IPS-BOOSTER
Status last verified
Mar 2023
First submitted
3 Dec 2018
Last updated
29 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: If requested we will consider sharing unidentified individual patient data

Publications

  • 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.

    PubMed 12355475

  • 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.

    PubMed 16287919

  • 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.

    PubMed 21834061

  • 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.

    PubMed 28552512

  • 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.

    PubMed 23051612

  • 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.

    PubMed 32087733

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in people with Rheumatoid Arthritis and Systemic Lupus, run by Region Skane.

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 1 inclusion and 3 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 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

2-fold rise in pneumococcal serotype-specific antibody concentration (time frame: 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination). 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 NCT03762824, which also lists 6 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 29 Mar 2023.

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