Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Phase 2

Completed

• Conditions: Response to Hepatitis A Vaccine

• Registration Number: NCT01360970
• Lead Sponsor: Lars Rombo

Brief 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).

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.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-05-24
• Study First Submitted QC: 2011-05-25
• Study First Posted: 2011-05-26
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
seroconversion after a single dose of hepatitis A vaccine	one month after dose	ELISA-titers are determined before first dose and at 1 and 6 months later

Secondary Outcome Measures

Name	Time	Method
seroconversion rates after a second dose of hepatitis A vaccine	12 monrths	We determine seroconversion rates before the second vaccine dose ( 6 months after the first) and at 1 and 6 months after the second dose

Trial Locations

Locations (2)

Dept infectious diseases; 🇸🇪 Karlstad, Sweden

Department of infectious diseases; 🇸🇪 Stockholm, Sweden