Clinical trial NCT03762824: Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease
Official title: Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Systemic Lupus
Sjögren Syndrome
Systemic Vasculitis
Spondyloarthritis
Keywords: Pneumococcal Conjugate Vaccine
Pneumococcal Disease
Immune Response
Inflammatory Rheumatic Disease
Pneumococcal Polysaccharide Vaccine
Immunosuppression
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 2-fold rise in pneumococcal serotype-specific antibody concentration
timeFrame: 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination
Secondary outcomes:
measure: Functional antibody response
timeFrame: 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination
measure: Long-term serotype-specific immunity to pneumococcal disease
timeFrame: 3 years after vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Skåne Universitets sjukhus, dept of rheumatology
name: Jehns Martineus, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.