Effects of Different Antirheumatic Treatments of Arthritis on Antibody Response Following Vaccination Using Prevenar®

NCT00828997 | Completed Phase 4 DMC

• 1 other identifier: EU-nr 2007-006539-29
• Study Type: interventional
• Target: 505
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies have analyzed serological responses following pneumococcal vaccination using 23-valent vaccination (Pneumovax) in Rheumatoid Arthritis (RA) patients that were on different therapeutic modalities including TNF-blockers and methotrexate. The results have shown that serological response was significantly reduced in RA patients receiving methotrexate compared to those receiving TNF-blockers. In contrast when using polypeptide immunisation (influenza vaccine) we found that anti-TNF significantly impaired the serological response compared to the methotrexate treated RA patients. The aim of this study is to analyze serological responses after Prevenar vaccination in patients with chronic arthritis and to study the impact of different treatment modalities on serological responses. It will be of interest to see if the result is different compared to the one seen after immunizing with 23-valent nonconjugated pneumococcal polysaccharide vaccine.

Conditions

Rheumatoid Arthritis; Spondylarthropathy

Keywords

rheumatoid arthritis; spondylarthropathy; immunological response following vaccination with Prevenar

Outcome Measures

Primary Outcomes (1)

• Serological responses to at least 2 pneumococcal serotypes included in Prevenar vaccine between different treatment groups.

  2009

Secondary Outcomes (1)

• to analyse if the result is different compared to the one seen after immunizing with 23-valent nonconjugated pneumococcal polysaccharide vaccine.

  2009

Study Arms (1)

Prevenar vaccine

OTHER

all participants are immunized with a dose of pneumococcal conjugate vaccine

Biological: Prevenar vaccination

Interventions

Prevenar vaccination BIOLOGICAL

vaccination with Prevenar vaccine in patients with arthritis

Prevenar vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Clinical diagnosis of RA or spondylarthropathy

You may not qualify if:

• Pregnancy
• Allergy
• Has received pneumococcal vaccination within 5 years

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Unknown Facility

Lund, Sweden

Location

Related Publications (6)

• Nagel J, Geborek P, Saxne T, Jonsson G, Englund M, Petersson IF, Nilsson JA, Truedsson L, Kapetanovic MC. The association between antibody levels before and after 7-valent pneumococcal conjugate vaccine immunization and subsequent pneumococcal infection in chronic arthritis patients. Arthritis Res Ther. 2015 May 19;17(1):124. doi: 10.1186/s13075-015-0636-z.

  PMID: 25986458 DERIVED

• Nagel J, Geborek P, Saxne T, Jonsson G, Englund M, Petersson IF, Nilsson JA, Kapetanovic MC. The risk of pneumococcal infections after immunization with pneumococcal conjugate vaccine compared to non-vaccinated inflammatory arthritis patients. Scand J Rheumatol. 2015;44(4):271-9. doi: 10.3109/03009742.2014.984754. Epub 2015 Feb 6.

  PMID: 25656734 DERIVED

• Crnkic Kapetanovic M, Saxne T, Jonsson G, Truedsson L, Geborek P. Rituximab and abatacept but not tocilizumab impair antibody response to pneumococcal conjugate vaccine in patients with rheumatoid arthritis. Arthritis Res Ther. 2013 Oct 30;15(5):R171. doi: 10.1186/ar4358.

  PMID: 24286269 DERIVED

• Crnkic Kapetanovic M, Saxne T, Truedsson L, Geborek P. Persistence of antibody response 1.5 years after vaccination using 7-valent pneumococcal conjugate vaccine in patients with arthritis treated with different antirheumatic drugs. Arthritis Res Ther. 2013 Jan 4;15(1):R1. doi: 10.1186/ar4127.

  PMID: 23286772 DERIVED

• Roseman C, Truedsson L, Kapetanovic MC. The effect of smoking and alcohol consumption on markers of systemic inflammation, immunoglobulin levels and immune response following pneumococcal vaccination in patients with arthritis. Arthritis Res Ther. 2012 Jul 23;14(4):R170. doi: 10.1186/ar3923.

  PMID: 22824238 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylarthropathies

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases

Study Officials

• Meliha C Kapetanovic, MD,PhD

  Dept of Rheumatology, Lund University Hospital, Lund, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: January 26, 2009
• Study Start: August 1, 2008
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

SE (1)