Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response

Conditions

RA, Scleroderma, Sjögrens, SLE, Syndrome, Vasculitis

Keywords

pneumococcal, vaccination, antibody, response, immunosuppressive, treatment, inflammatory, rheumatic, disease

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 immune response elicited by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. 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, efficacy in preventing invasive pneumococcal diseases and influenza related serious infections. 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.

Per Nived, Tore Saxne, Pierre Geborek, Thomas Mandl, Lillemor Skattum et al. (6 authors)

BMC Rheumatology2018-04-0522 citations

10.1186/s41927-018-0019-6

Immunogenicity and safety of pneumococcal vaccination in patients with systemic sclerosis

Roger Hesselstrand, Johanna Nagel, Tore Saxne, Pierre Geborek, Lillemor Skattum et al. (6 authors)

Lara D. Veeken2017-12-1616 citations

10.1093/rheumatology/kex471

Immune response to pneumococcal conjugate vaccine in patients with systemic vasculitis receiving standard of care therapy.

Nived P, Nagel J, Saxne T, Geborek P, Jönsson G, Skattum L, Kapetanovic MC.

2017-05-2515 citations

10.1016/j.vaccine.2017.05.044

Methotrexate reduces vaccine-specific immunoglobulin levels but not numbers of circulating antibody-producing B cells in rheumatoid arthritis after vaccination with a conjugate pneumococcal vaccine.

Kapetanovic MC, Nagel J, Nordström I, Saxne T, Geborek P, Rudin A.

2017-01-0936 citations

10.1016/j.vaccine.2016.12.068

Interventions

BIOLOGICAL0,5 mg Prevenar i.m.

BIOLOGICAL0,5 mg seasonal influenza vaccine i.m.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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, smoking habits and alcohol consumption.

Exclusion criteria

* age \<18 years; * pregnancy, * known intolerance of vaccine, * ongoing infection

Design outcomes

Primary

Measure	Time frame	Description
antibody response following vaccination	4-6 weeks after pneumococcal and influenza vaccination	measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains

Secondary

Measure	Time frame	Description
long-term immunity following pneumococcal vaccination	3 years after pneumococcal vaccination	measurement of antibody levels against different pneumococcal capsular serotypes
long-term immunity after vaccination with pneumococcal conjugate vaccine	5 years after vaccination	measurement of antibody levels against different pneumococcal polysaccharide serotypes

Other

Measure	Time frame	Description
The occurence of severe pneumococcal infections in immunized patients	within 5 years after pneumococcal vaccination	Analysis of the occurence of severe pneumococcal infections in immunized patients compared to matched not-immunized controls

Countries

Sweden

Outcome results

None listed