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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 20, 2015

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