Clinical trial NCT02240888: Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: RA
SLE
Vasculitis
Scleroderma
Sjögrens
Syndrome
Keywords: pneumococcal
vaccination
antibody
response
immunosuppressive
treatment
inflammatory
rheumatic
disease
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2014-09-16
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: TREATMENT

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.


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, smoking habits and alcohol consumption.

Exclusion Criteria:

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

Primary outcomes:
measure: antibody response following vaccination
timeFrame: 4-6 weeks after pneumococcal and influenza vaccination
Secondary outcomes:
measure: long-term immunity following pneumococcal vaccination
timeFrame: 3 years after pneumococcal vaccination
measure: long-term immunity after vaccination with pneumococcal conjugate vaccine
timeFrame: 5 years after vaccination
Other outcomes:
measure: The occurence of severe pneumococcal infections in immunized patients
timeFrame: within 5 years after pneumococcal vaccination
Locations:
city: Lund
country: Sweden
facility: Skåne University hospital, Dept of rheumatology
Study officials:
affiliation: Region Skåne
name: Meliha C Kapetanovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skåne Universitets sjukhus, dept of rheumatology
name: Jehns Martineus, MD
role: STUDY_DIRECTOR
References:
citation: Nived P, Saxne T, Geborek P, Mandl T, Skattum L, Kapetanovic MC. Antibody response to 13-valent pneumococcal conjugate vaccine is not impaired in patients with rheumatoid arthritis or primary Sjogren's syndrome without disease modifying treatment. BMC Rheumatol. 2018 Apr 5;2:12. doi: 10.1186/s41927-018-0019-6. eCollection 2018.
citation: Hesselstrand R, Nagel J, Saxne T, Geborek P, Skattum L, Kapetanovic MC. Immunogenicity and safety of pneumococcal vaccination in patients with systemic sclerosis. Rheumatology (Oxford). 2018 Apr 1;57(4):625-630. doi: 10.1093/rheumatology/kex471.
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: Kapetanovic MC, Nagel J, Nordstrom I, Saxne T, Geborek P, Rudin A. 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. Vaccine. 2017 Feb 7;35(6):903-908. doi: 10.1016/j.vaccine.2016.12.068. Epub 2017 Jan 9.