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Hepatitis A Vaccine in Patients With Immunomodulating Drugs

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01360970
First Posted: May 26, 2011
Last Update Posted: November 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lars Rombo, Sormland County Council, Sweden
  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: None (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 Lars Rombo, Sormland County Council, Sweden:

Primary Outcome Measures:
  • seroconversion after a single dose of hepatitis A vaccine [ Time Frame: one month after dose ]
    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 ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Lars Rombo
Investigators
Principal Investigator: lars rombo, MD Karolinska Institutet
  More Information

Responsible Party: Lars Rombo, Professor, Sormland County Council, Sweden
ClinicalTrials.gov Identifier: NCT01360970     History of Changes
Other Study ID Numbers: EU 2009-016055-22
First Submitted: May 24, 2011
First Posted: May 26, 2011
Last Update Posted: November 18, 2015
Last Verified: November 2015

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Vaccines
Methotrexate
Immunologic Factors
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors