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

NCT01131910 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2011-05-25

No results posted yet for this study

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

Conditions

Interventions

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)

BIOLOGICAL

TBE-vaccine

Solution for injection 0.5 ml im. 2 or 3 doses first years, 1 dose next year

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)

Sponsors & Collaborators

Principal Investigators

  • Lars Rombo, MD Professor · Somland county council

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Finland
  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01131910 on ClinicalTrials.gov