Status:
UNKNOWN
Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs
Lead Sponsor:
Sormland County Council, Sweden
Conditions:
Vaccine Response Impaired
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Hepatitis A vaccine is the most frequently used traveler's vaccine, yet data on its ability to induce protective immunity in immunosuppressed travelers are scarce. The investigators assess the hepatit...
Detailed Description
Methods: Parameters registered at baseline were: age, sex, duration of disease, medications, activity of disease (Visual Analogue Scale), Health Assessment Questionnaire Disability Index, Disease Acti...
Eligibility Criteria
Inclusion
- Diagnosis of rheumatoid arthritis
- TNF-alfa blocker and / or methotrexate in use as a medication against RA
- A desire to get protected against hepatitis A
- Men and women age 18-65 years
- Written informed consent
- Women of childbearing potential must use effective contraception -
Exclusion
- Treatment with rituximab within 9 months before study start
- Known previous hepatitis A infection
- Previous vaccination against hepatitis A
- Allergy to eggs or formaldehyde
- Pregnancy or lactation
- Excessive use of alcohol
- Mental retardation
- Acute disease at the time of examination (fever \> 38 degrees)
- Volunteer works as an employee of the researchers
- Previous vaccination against hepatitis A
- Egg-, hen-protein- or formaldehyde allergy
- Pregnancy or lactation
- Excessive use of alcohol
- Another vaccine given within a month
- Acute disease at the time of examination (fever \> 38 degrees)
- Not suitable for other reason in the investigator's opinion (other serious disease, i.e. AIDS/HIV-positive, cancer with ongoing cytostatic treatment)
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01446978
Start Date
September 1 2011
End Date
August 1 2016
Last Update
November 18 2015
Active Locations (4)
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1
Dept infectious diseases
Eskilstuna, Sweden, 631 88
2
Dept infectious diseases
Örebro, Sweden, 70185
3
Department of infectious diseases
Stockholm, Sweden, 17176
4
Dept infectious diseases
Uppsala, Sweden, 75185