Effects of Different Antirheumatic Treatments of Arthritis on Antibody Response Following Vaccination Using Prevenar® (PVA)
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ClinicalTrials.gov Identifier: NCT00828997 |
Recruitment Status :
Completed
First Posted : January 26, 2009
Last Update Posted : December 12, 2018
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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 |
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 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 |

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 |
- Serological responses to at least 2 pneumococcal serotypes included in Prevenar vaccine between different treatment groups. [ Time Frame: 2009 ]
- to analyse if the result is different compared to the one seen after immunizing with 23-valent nonconjugated pneumococcal polysaccharide vaccine. [ Time Frame: 2009 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 18 years
- Clinical diagnosis of RA or spondylarthropathy
Exclusion Criteria:
- Pregnancy
- Allergy
- Has received pneumococcal vaccination within 5 years

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): NCT00828997
Sweden | |
Lund, Sweden |
Principal Investigator: | Meliha C Kapetanovic, MD,PhD | Dept of Rheumatology, Lund University Hospital, Lund, Sweden |
Responsible Party: | Region Skane |
ClinicalTrials.gov Identifier: | NCT00828997 |
Other Study ID Numbers: |
EU-nr 2007-006539-29 |
First Posted: | January 26, 2009 Key Record Dates |
Last Update Posted: | December 12, 2018 |
Last Verified: | December 2018 |
rheumatoid arthritis spondylarthropathy immunological response following vaccination with Prevenar |
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 |