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

NCT02240888 | Completed

• 2 other identifiers: 2011/341Vaccimil
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

RA; SLE; Vasculitis; Scleroderma; Sjögrens; Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• antibody response following vaccination

  measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains

  4-6 weeks after pneumococcal and influenza vaccination

Secondary Outcomes (2)

• long-term immunity following pneumococcal vaccination

  3 years after pneumococcal vaccination

• long-term immunity after vaccination with pneumococcal conjugate vaccine

  5 years after vaccination

Other Outcomes (1)

• The occurence of severe pneumococcal infections in immunized patients

  within 5 years after pneumococcal vaccination

Study Arms (4)

vaccinated patients

ACTIVE COMPARATOR

patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m.

Biological: 0,5 mg Prevenar i.m.; Biological: 0,5 mg seasonal influenza vaccine i.m.

vaccinated controls

ACTIVE COMPARATOR

healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m.

Biological: 0,5 mg Prevenar i.m.; Biological: 0,5 mg seasonal influenza vaccine i.m.

seasonal influenza vaccine

ACTIVE COMPARATOR

patients with different inflammatory rheumatic diseases immunized with 0,5 mg seasonal influenza vaccine i.m.

Biological: 0,5 mg Prevenar i.m.; Biological: 0,5 mg seasonal influenza vaccine i.m.

non-vaccinated controls

ACTIVE COMPARATOR

healthy controls immunized with 0,5 mg seasonal influenza vaccine i.m.

Biological: 0,5 mg Prevenar i.m.; Biological: 0,5 mg seasonal influenza vaccine i.m.

Interventions

0,5 mg Prevenar i.m. BIOLOGICAL

non-vaccinated controls; seasonal influenza vaccine; vaccinated controls; vaccinated patients

0,5 mg seasonal influenza vaccine i.m. BIOLOGICAL

non-vaccinated controls; seasonal influenza vaccine; vaccinated controls; vaccinated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skåne University hospital, Dept of rheumatology

Lund, SE-22185, Sweden

Location

Related Publications (4)

• 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.

  PMID: 30886963 DERIVED

• 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.

  PMID: 29325173 DERIVED

• 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.

  PMID: 28552512 DERIVED

• 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.

  PMID: 28081972 DERIVED

MeSH Terms

Conditions

Vasculitis; Scleroderma, Diffuse; Syndrome; Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Meliha C Kapetanovic, MD, PhD

  Region Skåne

  PRINCIPAL INVESTIGATOR

• Jehns Martineus, MD

  Skåne Universitets sjukhus, dept of rheumatology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, associate professor

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 16, 2014
• Study Start: October 1, 2011
• Primary Completion: December 31, 2017
• Study Completion: May 31, 2018
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

SE (1)