Vaccine Response Impaired Clinical Trial
Official title:
Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate
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 hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis
(RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx).
In a previous study, 2 doses were not considered effective and there is therefore need for a
study with an additional dose
Methods: Parameters registered at baseline were: age, sex, duration of disease, medications, activity of disease (Visual Analogue Scale), Health Assessment Questionnaire Disability Index, Disease Activity Score, Acute phase reactant and total immunoglobulin G 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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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