Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease

NCT03762824 | Completed Phase 4

• 1 other identifier: IPS-BOOSTER
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis; Systemic Lupus; Sjögren Syndrome; Systemic Vasculitis; Spondyloarthritis

Keywords

Pneumococcal Conjugate Vaccine; Pneumococcal Disease; Immune Response; Inflammatory Rheumatic Disease; Pneumococcal Polysaccharide Vaccine; Immunosuppression

Outcome Measures

Primary Outcomes (1)

• 2-fold rise in pneumococcal serotype-specific antibody concentration

  Pneumococcal serotype-specific antibody concentration (12-valent)

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

Secondary Outcomes (2)

• Functional antibody response

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

• Long-term serotype-specific immunity to pneumococcal disease

  3 years after vaccination

Study Arms (5)

PCV13+PPV23 vaccinated patients

ACTIVE COMPARATOR

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; Biological: 23-valent pneumococcal polysaccharide vaccine

PCV13+PPV23 vaccinated controls

ACTIVE COMPARATOR

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; Biological: 23-valent pneumococcal polysaccharide vaccine

PPV23-booster to previous PCV-vaccinated patients

ACTIVE COMPARATOR

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

PCV13 to previous PPV23-vaccinated patients

ACTIVE COMPARATOR

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

PPV23-booster to previous PCV-vaccinated controls

ACTIVE COMPARATOR

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

Interventions

13-valent pneumococcal conjugate vaccine BIOLOGICAL

Pneumococcal conjugate vaccination during antirheumatic treatment

Also known as: Prevenar 13, PCV13

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

23-valent pneumococcal polysaccharide vaccine BIOLOGICAL

Pneumococcal polysaccharide vaccination during antirheumatic treatment

Also known as: Pneumovax, PPV23

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• known allergy/intolerance of pneumococcal vaccine
• pregnancy
• active infection

Sponsors & Collaborators

• Region Skane: lead

Related Publications (6)

• Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum. 2002 Sep;46(9):2287-93. doi: 10.1002/art.10524.

  PMID: 12355475 BACKGROUND

• Kapetanovic MC, Saxne T, Sjoholm A, Truedsson L, Jonsson G, Geborek P. Influence of methotrexate, TNF blockers and prednisolone on antibody responses to pneumococcal polysaccharide vaccine in patients with rheumatoid arthritis. Rheumatology (Oxford). 2006 Jan;45(1):106-11. doi: 10.1093/rheumatology/kei193. Epub 2005 Nov 15.

  PMID: 16287919 BACKGROUND

• Kapetanovic MC, Roseman C, Jonsson G, Truedsson L, Saxne T, Geborek P. Antibody response is reduced following vaccination with 7-valent conjugate pneumococcal vaccine in adult methotrexate-treated patients with established arthritis, but not those treated with tumor necrosis factor inhibitors. Arthritis Rheum. 2011 Dec;63(12):3723-32. doi: 10.1002/art.30580.

  PMID: 21834061 BACKGROUND

• Nived P, Nagel J, Saxne T, Geborek P, Jonsson G, Skattum L, Kapetanovic MC. Immune response to pneumococcal conjugate vaccine in patients with systemic vasculitis receiving standard of care therapy. Vaccine. 2017 Jun 22;35(29):3639-3646. doi: 10.1016/j.vaccine.2017.05.044. Epub 2017 May 25.

  PMID: 28552512 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2012 Oct 12;61(40):816-9.

  PMID: 23051612 BACKGROUND

• Nived P, Jonsson G, Settergren B, Einarsson J, Olofsson T, Jorgensen CS, Skattum L, Kapetanovic MC. Prime-boost vaccination strategy enhances immunogenicity compared to single pneumococcal conjugate vaccination in patients receiving conventional DMARDs, to some extent in abatacept but not in rituximab-treated patients. Arthritis Res Ther. 2020 Feb 22;22(1):36. doi: 10.1186/s13075-020-2124-3.

  PMID: 32087733 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Sjogren's Syndrome; Systemic Vasculitis; Spondylarthritis; Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine; 23-valent pneumococcal capsular polysaccharide vaccine; Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Spondylitis; Spinal Diseases; Bone Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Jehns Martineus, MD

  Skåne Universitets sjukhus, dept of rheumatology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 4, 2018
• Study Start: June 14, 2016
• Primary Completion: September 3, 2018
• Study Completion: December 21, 2020
• Last Updated: March 29, 2023

Record last verified: 2023-03