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Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

NCT ID: NCT01446978

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Vaccine Response Impaired

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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initial single dose of hep A vaccine

The participants will receive a single dose of hepatitis A vaccine at 0+1+6 months

Group Type ACTIVE_COMPARATOR

hepatitis A vaccine

Intervention Type BIOLOGICAL

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

initial double dose

Participants will receive one dose of hepatitis A vaccine in each M. deltoids and an additional dose at 6 months later

Group Type ACTIVE_COMPARATOR

hepatitis A vaccine

Intervention Type BIOLOGICAL

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

Interventions

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hepatitis A vaccine

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

Intervention Type BIOLOGICAL

hepatitis A vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sormland County Council, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Lars Rombo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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lars rombo, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Dept infectious diseases

Eskilstuna, , Sweden

Site Status

Dept infectious diseases

Örebro, , Sweden

Site Status

Department of infectious diseases

Stockholm, , Sweden

Site Status

Dept infectious diseases

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Rombo - 2

Identifier Type: -

Identifier Source: org_study_id