Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease (IPS-BOOSTER)

Region Skane

Status and phase: Completed; Phase 4

Conditions: Systemic Vasculitis; Sjögren Syndrome; Spondyloarthritis; Systemic Lupus; Rheumatoid Arthritis

Treatments: Biological: 13-valent pneumococcal conjugate vaccine; Biological: 23-valent pneumococcal polysaccharide vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT03762824

IPS-BOOSTER

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 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.

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.

Exclusion criteria

• known allergy/intolerance of pneumococcal vaccine
• pregnancy
• active infection

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 5 patient groups

PCV13+PPV23 vaccinated patients

Active Comparator group

Description:

Patients with different inflammatory rheumatic diseases are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.

Treatment:

Biological: 23-valent pneumococcal polysaccharide vaccine

Biological: 13-valent pneumococcal conjugate vaccine

PCV13+PPV23 vaccinated controls

Active Comparator group

Description:

Healthy controls are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.

Treatment:

Biological: 23-valent pneumococcal polysaccharide vaccine

Biological: 13-valent pneumococcal conjugate vaccine

PPV23-booster to previous PCV-vaccinated patients

Active Comparator group

Description:

Patients with different inflammatory rheumatic disease previously immunized with one dose PCV7 or PCV13 within another study (see VACCIMIL), are immunized with one dose PPV23 0.5 ml i.m.

Treatment:

Biological: 23-valent pneumococcal polysaccharide vaccine

PCV13 to previous PPV23-vaccinated patients

Active Comparator group

Description:

Patients with different inflammatory rheumatic disease previously immunized with one dose PPV23 within another study (see VACCIMIL), are immunized with one dose PCV13 0.5 ml i.m.

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

PPV23-booster to previous PCV-vaccinated controls

Active Comparator group

Description:

Healthy controls previously immunized with one dose PCV7 or PCV13 within another study (see VACCIMIL), are immunized with one dose PPV23 0.5 ml i.m.

Treatment:

Biological: 23-valent pneumococcal polysaccharide vaccine