Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Sormland County Council, Sweden

Status and phase

Unknown

Phase 2

Conditions

Vaccine Response Impaired

Treatments

Biological: hepatitis A vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT01446978

Rombo - 2

Details and patient eligibility

About

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

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)