Trial | NCT01360970  Report issue

Title

Hepatitis A Vaccine in Patients With Immunomodulating Drugs
Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    68
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.
Study Started
Sep 30
2009
Primary Completion
May 31
2011
Study Completion
May 31
2011
Last Update
Nov 18
2015
Estimate

Biological hepatitis A vaccine ( HAVRIX or EPAXAL)

1.0 ml im ( Havrix) and 0.5 ml im (Epaxal. Both vaccines are given two times with 6 months interval

Criteria 

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)
No Results Posted