Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease

Phase 4

Completed

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

• Registration Number: NCT03762824
• Lead Sponsor: Region Skane

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-14
• Primary Completion: 2018-09-03
• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Study Completion: 2020-12-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
2-fold rise in pneumococcal serotype-specific antibody concentration	8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination	Pneumococcal serotype-specific antibody concentration (12-valent)

Secondary Outcome Measures

Name	Time	Method
Long-term serotype-specific immunity to pneumococcal disease	3 years after vaccination	Pneumococcal serotype-specific antibody concentration
Functional antibody response	8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination	Opsonophagocytosis activity assay