TBE-vaccine to Patients With Rheumatoid Arthritis Who Are Using Immunosuppressive Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01131910
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : May 25, 2011
Karolinska Institutet
Information provided by:
Sormland County Council, Sweden

Brief Summary:
The investigators intend to check whether the efficacy of a TBE-vaccine is substantially deteriorated in patients with rheumatoid arthritis who are treated with drugs which suppress the immune system. The investigators aim to detect a difference of at least 10 % compared to healthy individuals (historical controls) in protection when analysed with serology. If the investigators detect a difference, the investigators will continue to explore whether protection can be achieved by additional doses

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Exposed to TBE-virus Immunosuppression Biological: TBE-vaccine Biological: Vaccination against TBE Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of TBE-vaccine to Patients With Rheumatic Disease Who Are Treated With Methotrexate and/or TNF-alfa Blocking Drugs
Study Start Date : May 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vaccination against TBE

Less than 60 years old: Two doses of TBE- vaccine separated by a month and a third dose 12 months after the first dose

60 years and above: Three doses, given at 0+1+3 months and a 4 th dose 12 months after the first dose

Biological: TBE-vaccine
Solution of 0.5 ml for intramuscular use. Given in 2 doses separated by 1 month to healthy individuals less than 60 years old. (3 doses 0+1+3 months to those are 60 and above in Sweden)
Other Name: ATC-code J07B A01

Biological: TBE-vaccine
Solution for injection 0.5 ml im. 2 or 3 doses first years, 1 dose next year
Other Name: J07B A01

Biological: Vaccination against TBE
0.5 ml im at 0 and 1 month ( less than 60 years old) or 0 and 1 and 3 months (at least 60 years old)

Primary Outcome Measures :
  1. Seroconversion rate [ Time Frame: 1 year ]
    The humoral response to TBE-vaccine

Information from the National Library of Medicine

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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:

  • Rheumatoid arthritis treated with methotrexate and/or TNF-alfa blocking drugs
  • Interest to be vaccinated
  • Written consent
  • Age 18 years or more

Exclusion Criteria:

  • Previous TBE-infection
  • Previous Vaccination with TBE
  • Pregnancy
  • Breast feeding
  • Treatment with rituximab the last 9 months
  • Inability to follow study protocol

Information from the National Library of Medicine

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 identifier (NCT number): NCT01131910

Dept infectious diseases
Helsingfors, Finland, 00029
Dept infectious diseases
Eskilstuna, Sweden, 631 88
Dept. infectious diseases
Eskilstuna, Sweden, 631 88
Department of infectious diseases
Stockholm, Sweden, 17176
Dept infectious diseases
Uppsala, Sweden, 751 85
Department of infectious diseases
Örebro, Sweden
Sponsors and Collaborators
Sormland County Council, Sweden
Karolinska Institutet
Principal Investigator: Lars Rombo, MD Professor Somland county council

Responsible Party: Professor Lars Rombo, Sormland County Council Identifier: NCT01131910     History of Changes
Other Study ID Numbers: 2010-019438-28
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: May 25, 2011
Last Verified: April 2010

Keywords provided by Sormland County Council, Sweden:
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs