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NCT Number: NCT00828997

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylarthropathy Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lund, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Prevenar vaccination

Biological

vaccination with Prevenar vaccine in patients with arthritis

Primary outcomes

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

    Time frame: 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.

    Time frame: 2009

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University

Registry information

Official study title

Effects of Different Anti-rheumatic Treatments of Arthritis on Antibody Response Following Pneumococcal Vaccination Using Prevenar®

Acronym: PVA

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Jan 26, 2009
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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