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

Region Skane

Status: Completed

Conditions: Sjögrens; RA; SLE; Scleroderma; Vasculitis; Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02240888

2011/341

Vaccimil (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 4 patient groups

vaccinated patients

Active Comparator group

Description:

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

Treatment:

Biological: 0,5 mg Prevenar i.m.

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

vaccinated controls

Active Comparator group

Description:

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

Treatment:

Biological: 0,5 mg Prevenar i.m.

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

seasonal influenza vaccine

Active Comparator group

Description:

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

Treatment:

Biological: 0,5 mg Prevenar i.m.

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

non-vaccinated controls

Active Comparator group

Description:

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

Treatment:

Biological: 0,5 mg Prevenar i.m.

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