Vaccine Response Impaired
Conditions
Keywords
hepatitis A vaccine, TNF-alfa inhibitory drugs, Rheumatoid arthritis, methotrexate
Brief summary
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
Detailed description
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.
Interventions
BIOLOGICALhepatitis A vaccine
3 doses of hepatitis A vaccine, given at 0+1+6 months
Sponsors
Sormland County Council, Sweden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of rheumatoid arthritis * TNF-alfa blocker and / or methotrexate 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-, hen-protein- 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| seroconversion after the first dose/doses of hepatitis A vaccine | one month after the first dose/doses | ELISA-titers are determined before the first dose/doses and at 1 month later |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| seroconversion rates after three doses of hepatitis A vaccine | 12 months after the first doses | We determine seroconversion rates before the third vaccine dose (6 months after the first) and at 1 and 6 months after the second dose |
Countries
Sweden
Outcome results
None listed