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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis; Exposed to TBE-virus; Immunosuppression
• Interventions: Biological: TBE-vaccine; Biological: Vaccination against TBE

• Registration Number: NCT01131910
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-04
• Study Start: 2010-05
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-05-26
• Study First Posted: 2010-05-27
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2011-05-24
• Last Update Posted: 2011-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccination against TBE	TBE-vaccine	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
Vaccination against TBE	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

Primary Outcome Measures

Name	Time	Method
Seroconversion rate	1 year	The humoral response to TBE-vaccine

Trial Locations

Locations (3)

Dept infectious diseases; 🇸🇪 Uppsala, Sweden

Department of infectious diseases; 🇸🇪 Örebro, Sweden

Dept. infectious diseases; 🇸🇪 Eskilstuna, Sweden