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

• ClinicalTrials.gov Identifier: NCT00828997
• Recruitment Status: Completed
• First Posted: January 26, 2009
• Last Update Posted: December 12, 2018
• Sponsor: Region Skane
• Collaborator: Lund University
• Information provided by (Responsible Party): Region Skane

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis; Spondylarthropathy	Biological: Prevenar vaccination	Phase 4

Detailed Description:

Background: 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 (Rheumatology (Oxford) 2006 Jan; 45(1):106-11).

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 RA or spondylarthropathy 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.

Study design:

Unblinded study in RA patients and patients with spondylarthropathies. All subjects will be vaccinated once with Prevenar and the serological response will be followed by blood draws.

Patient Population to be Included:

RA patients on methotrexate and/or other DMARDS RA patients on anti-TNF drugs as monotherapy RA patients on anti-TNF +MTX and/or other DMARDSs Spondylarthropathy patients on anti-TNF drugs as monotherapy Spondylarthropathy patients on anti-TNF drugs +MTX Spondylarthropathy patients on NSAIDs (There is a possibility to stratify for steroid use).

Primary and Secondary Efficacy Endpoints:

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

An ethical approval from the Ethical Review Board at Lund University is mandatory for this study as well as an approval from the Swedish MPA.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 505 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effects of Different Anti-rheumatic Treatments of Arthritis on Antibody Response Following Pneumococcal Vaccination Using Prevenar®
• Study Start Date: August 2008
• Actual Primary Completion Date: January 2018
• Actual Study Completion Date: January 2018

Arms and Interventions

Arm	Intervention/treatment
Prevenar vaccine; all participants are immunized with a dose of pneumococcal conjugate vaccine	Biological: Prevenar vaccination; vaccination with Prevenar vaccine in patients with arthritis

Outcome Measures

Primary Outcome Measures :

1. Serological responses to at least 2 pneumococcal serotypes included in Prevenar vaccine between different treatment groups. [ Time Frame: 2009 ]

Secondary Outcome Measures :

1. to analyse if the result is different compared to the one seen after immunizing with 23-valent nonconjugated pneumococcal polysaccharide vaccine. [ Time Frame: 2009 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

Sweden

Lund, Sweden

Sponsors and Collaborators

Region Skane

Lund University

Investigators

• Principal Investigator: Meliha C Kapetanovic, MD,PhD; Dept of Rheumatology, Lund University Hospital, Lund, Sweden

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

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.

• Responsible Party: Region Skane
• ClinicalTrials.gov Identifier: NCT00828997
• Other Study ID Numbers: EU-nr 2007-006539-29
• First Posted: January 26, 2009
• Last Update Posted: December 12, 2018
• Last Verified: December 2018

Keywords provided by Region Skane:

rheumatoid arthritis; spondylarthropathy; immunological response following vaccination with Prevenar

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Spondylarthropathies; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Heptavalent Pneumococcal Conjugate Vaccine; Immunologic Factors; Physiological Effects of Drugs