Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Sormland County Council, Sweden150 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

150

Conditions

Vaccine Response Impaired

Interventions

hepatitis A vaccineBIOLOGICAL

3 doses of hepatitis A vaccine, given at 0+1+6 months

hepatitis A vaccineBIOLOGICAL

Two doses of hepatitis A vaccine given at day 0, one in each M deltoids. An additional dose will be given at 6 months later

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (4)

Dept infectious diseases

Eskilstuna, Sweden

Dept infectious diseases

Örebro, Sweden

Department of infectious diseases

Stockholm, Sweden

Dept infectious diseases

Uppsala, Sweden

Outcomes

Primary Outcomes

seroconversion after the first dose/doses of hepatitis A vaccine

ELISA-titers are determined before the first dose/doses and at 1 month later

Time frame: one month after the first dose/doses

Secondary Outcomes

seroconversion rates after three doses of hepatitis A vaccine

We determine seroconversion rates before the third vaccine dose (6 months after the first) and at 1 and 6 months after the second dose

Time frame: 12 months after the first doses

Data from ClinicalTrials.gov

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