Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| initial single dose of hep A vaccine | Active Comparator | The participants will receive a single dose of hepatitis A vaccine at 0+1+6 months |
|
| initial double dose | Active Comparator | Participants will receive one dose of hepatitis A vaccine in each M. deltoids and an additional dose at 6 months later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hepatitis A vaccine | Biological | 3 doses of hepatitis A vaccine, given at 0+1+6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| seroconversion after the first dose/doses of hepatitis A vaccine | ELISA-titers are determined before the first dose/doses and at 1 month later | one month after the first dose/doses |
| Measure | Description | Time Frame |
|---|---|---|
| seroconversion rates after three doses of hepatitis A vaccine | We determine seroconversion rates before the third vaccine dose (6 months after the first) and at 1 and 6 months after the second dose | 12 months after the first doses |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| lars rombo, MD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept infectious diseases | Eskilstuna | 631 88 | Sweden | |||
| Dept infectious diseases |
Not provided
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| hepatitis A vaccine | Biological | Two doses of hepatitis A vaccine given at day 0, one in each M deltoids. An additional dose will be given at 6 months later |
|
| Örebro |
| 70185 |
| Sweden |
| Department of infectious diseases | Stockholm | 17176 | Sweden |
| Dept infectious diseases | Uppsala | 75185 | 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 |