Hepatitis A Vaccine in Patients With Immunomodulating Drugs

This study has been completed.
Sponsor:
Information provided by:
Sormland County Council, Sweden
ClinicalTrials.gov Identifier:
NCT01360970
First received: May 24, 2011
Last updated: May 25, 2011
Last verified: May 2011
  Purpose

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).


Condition Intervention Phase
Response to Hepatitis A Vaccine
Biological: hepatitis A vaccine ( HAVRIX or EPAXAL)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate

Resource links provided by NLM:


Further study details as provided by Sormland County Council, Sweden:

Primary Outcome Measures:
  • seroconversion after a single dose of hepatitis A vaccine [ Time Frame: one month after dose ] [ Designated as safety issue: No ]
    ELISA-titers are determined before first dose and at 1 and 6 months later


Secondary Outcome Measures:
  • seroconversion rates after a second dose of hepatitis A vaccine [ Time Frame: 12 monrths ] [ Designated as safety issue: No ]
    We determine seroconversion rates before the second vaccine dose ( 6 months after the first) and at 1 and 6 months after the second dose


Enrollment: 68
Study Start Date: September 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: hepatitis A vaccine ( HAVRIX or EPAXAL)
    1.0 ml im ( Havrix) and 0.5 ml im (Epaxal. Both vaccines are given two times with 6 months interval
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01360970

Locations
Finland
Dept infectious diseases
Helsingfors, Finland, 00029
Sweden
Dept infectious diseases
Eskilstuna, Sweden, 631 88
Dept infectious diseases
Karlstad, Sweden, 651 85
Department of infectious diseases
Stockholm, Sweden, 17176
Sponsors and Collaborators
Sormland County Council, Sweden
Investigators
Principal Investigator: lars rombo, MD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Lars Rombo, Sormland county council
ClinicalTrials.gov Identifier: NCT01360970     History of Changes
Other Study ID Numbers: EU 2009-016055-22
Study First Received: May 24, 2011
Last Updated: May 25, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Sormland County Council, Sweden:
hepatitis A vaccine
TNF-alfa inhibitory drugs
Rheumatoid arthritis
methotrexate

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Arthritis, Rheumatoid
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014