Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Phase 2

• Conditions: Vaccine Response Impaired
• Interventions: Biological: hepatitis A vaccine

• Registration Number: NCT01446978
• Lead Sponsor: Sormland County Council, Sweden

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-03
• Study First Submitted QC: 2011-10-03
• Study First Posted: 2011-10-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-18
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
initial double dose	hepatitis A vaccine	Participants will receive one dose of hepatitis A vaccine in each M. deltoids and an additional dose at 6 months later
initial single dose of hep A vaccine	hepatitis A vaccine	The participants will receive a single dose of hepatitis A vaccine at 0+1+6 months

Primary Outcome Measures

Name	Time	Method
seroconversion after the first dose/doses of hepatitis A vaccine	one month after the first dose/doses	ELISA-titers are determined before the first dose/doses and at 1 month later

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Department of infectious diseases; 🇸🇪 Stockholm, Sweden

Dept infectious diseases; 🇸🇪 Örebro, Sweden