Exposed to TBE-virus, Immunosuppression, Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis, TBE-vaccine, Immunosuppression
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
Interventions
BIOLOGICALTBE-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)
BIOLOGICALVaccination 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)
Sponsors
Karolinska Institutet
Sormland County Council, Sweden
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate | 1 year | The humoral response to TBE-vaccine |
Countries
Finland, Sweden
Outcome results
None listed