Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

November 17, 2015 updated by: Lars Rombo, Sormland County Council, Sweden

Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Eskilstuna, Sweden, 631 88
        • Dept infectious diseases
      • Stockholm, Sweden, 17176
        • Department of Infectious Diseases
      • Uppsala, Sweden, 75185
        • Dept infectious diseases
      • Örebro, Sweden, 70185
        • Dept infectious diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: initial single dose of hep A vaccine
The participants will receive a single dose of hepatitis A vaccine at 0+1+6 months
Biological: hepatitis A vaccine
3 doses of hepatitis A vaccine, given at 0+1+6 months
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
ACTIVE_COMPARATOR: initial double dose
Participants will receive one dose of hepatitis A vaccine in each M. deltoids and an additional dose at 6 months later
Biological: hepatitis A vaccine
3 doses of hepatitis A vaccine, given at 0+1+6 months
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
seroconversion after the first dose/doses of hepatitis A vaccine
Time Frame: one month after the first dose/doses
ELISA-titers are determined before the first dose/doses and at 1 month later
one month after the first dose/doses

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
seroconversion rates after three doses of hepatitis A vaccine
Time Frame: 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
12 months after the first doses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sormland County Council, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ANTICIPATED)

August 1, 2016

Study Completion (ANTICIPATED)

August 1, 2016

Study Registration Dates

First Submitted

October 3, 2011

First Submitted That Met QC Criteria

October 3, 2011

First Posted (ESTIMATE)

October 5, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rombo - 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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