NCT03762824

Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease

Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Rheumatoid Arthritis
• Systemic Lupus
• Sjögren Syndrome
• Systemic Vasculitis
• Spondyloarthritis

Interventions

Type	Name	Description
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	Pneumococcal conjugate vaccination during antirheumatic treatment
BIOLOGICAL	23-valent pneumococcal polysaccharide vaccine	Pneumococcal polysaccharide vaccination during antirheumatic treatment

Timeline

• Start date: 2016-06-14
• Primary completion: 2018-09-03
• Completion: 2020-12-21
• First posted: 2018-12-04
• Last updated: 2023-03-29