Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Methods: Parameters registered at baseline were: age, sex, duration of disease, medications, activity of disease (Visual Analogue Scale=VAS, Health Assessment Questionnaire Disability Index = HAQ, Disease Activity Score =DAS-28, CRP and total IgG in plasma). Hepatitis A vaccine (Epaxal or Havrix) were given at 0 and 6 months. Hepatitis A virus (HAV) antibodies is measured before vaccination and at month 1, 6 (before dose 2), 7 and 12 with quantitative HAV IgG, using the HAVAb-IgG Architect System, and by the HAVAB 2.0 assay on the AxSYM machine from Abbott. The level of protective immunity to HAV is defined as HAV IgG > 10mIU/mL.

Inclusion criteria

• Diagnosis of rheumatoid arthritis
• TNF-alfa blocker and / or methotraxate 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 criteria

• 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-, henprotein- 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)