Hepatitis A Vaccine in Patients With Immunomodulating Drugs
Hepatitis A Vaccine in Patients With Immunomodulating Drugs
Hepatitis A vaccine is the most frequently used traveller's vaccine, yet data on its ability
 to induce protective immunity in immunosuppressed travellers are scarce. The investigators
 assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis
 (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx).
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)