Hepatitis A Vaccine in Patients With Immunomodulating Drugs
Information source: Sormland County Council, Sweden
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Response to Hepatitis A Vaccine
Intervention: hepatitis A vaccine ( HAVRIX or EPAXAL) (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: Sormland County Council, Sweden Official(s) and/or principal investigator(s):
lars rombo, MD, Principal Investigator, Affiliation: Karolinska Institutet
Summary
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).
Clinical Details
Official title: Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: seroconversion after a single dose of hepatitis A vaccine
Secondary outcome: seroconversion rates after a second dose of hepatitis A vaccine
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Dept infectious diseases, Helsingfors 00029, Finland
Dept infectious diseases, Eskilstuna 631 88, Sweden
Dept infectious diseases, Karlstad 651 85, Sweden
Department of infectious diseases, Stockholm 17176, Sweden
Additional Information
Starting date: September 2009
Last updated: May 25, 2011
|
