Clinical trial

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

Name

IPS-BOOSTER

Description

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.

Trial arms

Trial start

2016-06-14

Estimated PCD

2018-09-03

Trial end

2020-12-21

Status

Completed

Phase

Early phase I

Treatment

13-valent pneumococcal conjugate vaccine

Pneumococcal conjugate vaccination during antirheumatic treatment

Arms:

PCV13 to previous PPV23-vaccinated patients, PCV13+PPV23 vaccinated controls, PCV13+PPV23 vaccinated patients

Other names:

Prevenar 13, PCV13

23-valent pneumococcal polysaccharide vaccine

Pneumococcal polysaccharide vaccination during antirheumatic treatment

Arms:

PCV13+PPV23 vaccinated controls, PCV13+PPV23 vaccinated patients, PPV23-booster to previous PCV-vaccinated controls, PPV23-booster to previous PCV-vaccinated patients

Other names:

Pneumovax, PPV23

Size

300

Primary endpoint

2-fold rise in pneumococcal serotype-specific antibody concentration

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 300, 'type': 'ACTUAL'}}

Updated at

2023-03-29

1 organization

2 products

5 indications

Organization

Region Skåne

Product

13-valent pneumococcal conjugate vaccine

Indication

Rheumatoid Arthritis

Indication