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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03762824
Recruitment Status : Active, not recruiting
First Posted : December 4, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Systemic Lupus Sjögren Syndrome Systemic Vasculitis Spondyloarthritis Biological: 13-valent pneumococcal conjugate vaccine Biological: 23-valent pneumococcal polysaccharide vaccine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response.
Actual Study Start Date : June 14, 2016
Actual Primary Completion Date : September 3, 2018
Estimated Study Completion Date : October 1, 2021


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762824


Sponsors and Collaborators
Region Skane
Investigators
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Study Director: Jehns Martineus, MD Skåne Universitets sjukhus, dept of rheumatology
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03762824    
Other Study ID Numbers: IPS-BOOSTER
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If requested we will consider sharing unidentified individual patient data

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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
Keywords provided by Region Skane:
Pneumococcal Conjugate Vaccine
Pneumococcal Disease
Immune Response
Inflammatory Rheumatic Disease
Pneumococcal Polysaccharide Vaccine
Immunosuppression
Additional relevant MeSH terms:
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Rheumatic Diseases
Spondylarthritis
Sjogren's Syndrome
Vasculitis
Systemic Vasculitis
Collagen Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylitis
Spinal Diseases
Bone Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs