Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease

Rheumatoid Arthritis Clinical Trial

— IPS-BOOSTER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03762824
• Other study ID #: IPS-BOOSTER
• Status: Completed
• Phase: Phase 4
• Start date: June 14, 2016
• Est. completion date: December 21, 2020

Study information

• Verified date: March 2023
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 21, 2020
• Est. primary completion date: September 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Rheumatic Diseases
• Rheumatoid Arthritis
• Sjögren Syndrome
• Sjogren's Syndrome
• Spondylarthritis
• Spondylitis
• Spondyloarthritis
• Systemic Lupus
• Systemic Vasculitis
• Vasculitis

Intervention

Biological:
• 13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccination during antirheumatic treatment
• 23-valent pneumococcal polysaccharide vaccine
Pneumococcal polysaccharide vaccination during antirheumatic treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-fold rise in pneumococcal serotype-specific antibody concentration	Pneumococcal serotype-specific antibody concentration (12-valent)	8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination
Secondary	Functional antibody response	Opsonophagocytosis activity assay	8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination
Secondary	Long-term serotype-specific immunity to pneumococcal disease	Pneumococcal serotype-specific antibody concentration	3 years after vaccination