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

Sormland County Council, Sweden

Status and phase: Completed; Phase 2

Conditions: Exposed to TBE-virus; Immunosuppression; Rheumatoid Arthritis

Treatments: Biological: TBE-vaccine; Biological: Vaccination against TBE

Study type: Interventional

Funder types: Other

Identifiers

NCT01131910

2010-019438-28

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

Vaccination against TBE

Experimental group

Description:

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

Treatment:

Biological: Vaccination against TBE

Biological: TBE-vaccine

Biological: TBE-vaccine