Clinical trial NCT01446978: Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs
Official title: Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Vaccine Response Impaired
Keywords: hepatitis A vaccine
TNF-alfa inhibitory drugs
Rheumatoid arthritis
methotrexate
Lead sponsor: Sormland County Council, Sweden
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: seroconversion after the first dose/doses of hepatitis A vaccine
timeFrame: one month after the first dose/doses
Secondary outcomes:
measure: seroconversion rates after three doses of hepatitis A vaccine
timeFrame: 12 months after the first doses
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Dept infectious diseases
city: Stockholm
country: Sweden
facility: Department of infectious diseases
city: Uppsala
country: Sweden
facility: Dept infectious diseases
city: Örebro
country: Sweden
facility: Dept infectious diseases
Study officials:
affiliation: Karolinska Institutet
name: lars rombo, MD
role: PRINCIPAL_INVESTIGATOR
References: