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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hepatitis A vaccine ( HAVRIX or EPAXAL) | Biological | 1.0 ml im ( Havrix) and 0.5 ml im (Epaxal. Both vaccines are given two times with 6 months interval |
| Measure | Description | Time Frame |
|---|---|---|
| seroconversion after a single dose of hepatitis A vaccine | ELISA-titers are determined before first dose and at 1 and 6 months later | one month after dose |
| Measure | Description | Time Frame |
|---|---|---|
| seroconversion rates after a second dose of hepatitis A vaccine | We determine seroconversion rates before the second vaccine dose ( 6 months after the first) and at 1 and 6 months after the second dose | 12 monrths |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| lars rombo, MD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept infectious diseases | Helsingfors | 00029 | Finland | |||
| Dept infectious diseases |
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| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| C530970 | epaxal berna |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Eskilstuna |
| 631 88 |
| Sweden |
| Dept infectious diseases | Karlstad | 651 85 | Sweden |
| Department of infectious diseases | Stockholm | 17176 | Sweden |
| D009140 |
| Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D045424 |
| Complex Mixtures |