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Completed

NCT Number: NCT03762824

Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bacterial Infections Bacterial Infections and Mycoses Bone Diseases Cardiovascular Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Gram-Positive Bacterial Infections Immune System Diseases Infections Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Pneumococcal Infections Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Sjögren Syndrome Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylitis Spondyloarthritis Stomatognathic Diseases Streptococcal Infections Systemic Lupus Systemic Vasculitis Vascular Diseases Vasculitis Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

13-valent Pneumococcal Conjugate Vaccine

Biological

Pneumococcal conjugate vaccination during antirheumatic treatment

Other names: Prevenar 13, PCV13

23-valent pneumococcal polysaccharide vaccine

Biological

Pneumococcal polysaccharide vaccination during antirheumatic treatment

Other names: Pneumovax, PPV23

Primary outcomes

  1. 2-fold rise in pneumococcal serotype-specific antibody concentration

    Time frame: 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination

    Pneumococcal serotype-specific antibody concentration (12-valent)

Secondary outcomes

  1. Functional antibody response

    Time frame: 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination

    Opsonophagocytosis activity assay

  2. Long-term serotype-specific immunity to pneumococcal disease

    Time frame: 3 years after vaccination

    Pneumococcal serotype-specific antibody concentration

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Acronym: IPS-BOOSTER

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Dec 4, 2018
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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