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

March 28, 2023 updated by: Region Skane

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PCV13+PPV23 vaccinated patients
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.
Biological: 13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccination during antirheumatic treatment
Other Names:
  • Prevenar 13
  • PCV13
Biological: 23-valent pneumococcal polysaccharide vaccine
Pneumococcal polysaccharide vaccination during antirheumatic treatment
Other Names:
  • Pneumovax
  • PPV23
Active Comparator: PCV13+PPV23 vaccinated controls
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.
Biological: 13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccination during antirheumatic treatment
Other Names:
  • Prevenar 13
  • PCV13
Biological: 23-valent pneumococcal polysaccharide vaccine
Pneumococcal polysaccharide vaccination during antirheumatic treatment
Other Names:
  • Pneumovax
  • PPV23
Active Comparator: PPV23-booster to previous PCV-vaccinated patients
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.
Biological: 23-valent pneumococcal polysaccharide vaccine
Pneumococcal polysaccharide vaccination during antirheumatic treatment
Other Names:
  • Pneumovax
  • PPV23
Active Comparator: PCV13 to previous PPV23-vaccinated patients
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.
Biological: 13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccination during antirheumatic treatment
Other Names:
  • Prevenar 13
  • PCV13
Active Comparator: PPV23-booster to previous PCV-vaccinated controls
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.
Biological: 23-valent pneumococcal polysaccharide vaccine
Pneumococcal polysaccharide vaccination during antirheumatic treatment
Other Names:
  • Pneumovax
  • PPV23

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Study Director: Jehns Martineus, MD, Skåne Universitets sjukhus, dept of rheumatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2016

Primary Completion (Actual)

September 3, 2018

Study Completion (Actual)

December 21, 2020

Study Registration Dates

First Submitted

December 3, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 4, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPS-BOOSTER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

If requested we will consider sharing unidentified individual patient data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on 13-valent pneumococcal conjugate vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe