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

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ClinicalTrials.gov Identifier: NCT03762824

Recruitment Status : Completed

First Posted : December 4, 2018

Last Update Posted : February 25, 2021

Sponsor:

Information provided by (Responsible Party):

Region Skane

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.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis Systemic Lupus Sjögren Syndrome Systemic Vasculitis Spondyloarthritis	Biological: 13-valent pneumococcal conjugate vaccine Biological: 23-valent pneumococcal polysaccharide vaccine	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	300 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response.
Actual Study Start Date :	June 14, 2016
Actual Primary Completion Date :	September 3, 2018
Actual Study Completion Date :	December 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Sjögren syndrome Rheumatoid arthritis

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: PCV13+PPV23 vaccinated patients 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.	Biological: 13-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccination during antirheumatic treatment Other Names: Prevenar 13 PCV13 Biological: 23-valent pneumococcal polysaccharide vaccine Pneumococcal polysaccharide vaccination during antirheumatic treatment Other Names: Pneumovax PPV23
Active Comparator: PCV13+PPV23 vaccinated controls 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.	Biological: 13-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccination during antirheumatic treatment Other Names: Prevenar 13 PCV13 Biological: 23-valent pneumococcal polysaccharide vaccine Pneumococcal polysaccharide vaccination during antirheumatic treatment Other Names: Pneumovax PPV23
Active Comparator: PPV23-booster to previous PCV-vaccinated patients 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.	Biological: 23-valent pneumococcal polysaccharide vaccine Pneumococcal polysaccharide vaccination during antirheumatic treatment Other Names: Pneumovax PPV23
Active Comparator: PCV13 to previous PPV23-vaccinated patients 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.	Biological: 13-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccination during antirheumatic treatment Other Names: Prevenar 13 PCV13
Active Comparator: PPV23-booster to previous PCV-vaccinated controls 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.	Biological: 23-valent pneumococcal polysaccharide vaccine Pneumococcal polysaccharide vaccination during antirheumatic treatment Other Names: Pneumovax PPV23

Outcome Measures

Primary Outcome Measures :

2-fold rise in pneumococcal serotype-specific antibody concentration [ Time Frame: 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination ]
Pneumococcal serotype-specific antibody concentration (12-valent)

Secondary Outcome Measures :

Functional antibody response [ Time Frame: 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination ]
Opsonophagocytosis activity assay
Long-term serotype-specific immunity to pneumococcal disease [ Time Frame: 3 years after vaccination ]
Pneumococcal serotype-specific antibody concentration

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762824

Sponsors and Collaborators

Region Skane

Investigators

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Study Director:	Jehns Martineus, MD	Skåne Universitets sjukhus, dept of rheumatology

More Information

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.

Kapetanovic MC, Saxne T, Sjöholm A, Truedsson L, Jönsson 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. Epub 2005 Nov 15.

Kapetanovic MC, Roseman C, Jönsson 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.

Nived P, Nagel J, Saxne T, Geborek P, Jönsson 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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nived P, Jönsson G, Settergren B, Einarsson J, Olofsson T, Jørgensen 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.

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Responsible Party:	Region Skane
ClinicalTrials.gov Identifier:	NCT03762824
Other Study ID Numbers:	IPS-BOOSTER
First Posted:	December 4, 2018 Key Record Dates
Last Update Posted:	February 25, 2021
Last Verified:	February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	If requested we will consider sharing unidentified individual patient data

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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

Keywords provided by Region Skane:


Pneumococcal Conjugate Vaccine Pneumococcal Disease Immune Response	Inflammatory Rheumatic Disease Pneumococcal Polysaccharide Vaccine Immunosuppression

Additional relevant MeSH terms:

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Rheumatic Diseases Sjogren's Syndrome Spondylarthritis Vasculitis Systemic Vasculitis Collagen Diseases Arthritis Joint Diseases Musculoskeletal Diseases Arthritis, Rheumatoid Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Xerostomia Salivary Gland Diseases	Mouth Diseases Stomatognathic Diseases Dry Eye Syndromes Lacrimal Apparatus Diseases Eye Diseases Spondylitis Spinal Diseases Bone Diseases Vascular Diseases Cardiovascular Diseases Vaccines Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs

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