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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

May 24, 2011
May 25, 2011
September 2009
May 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01360970 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Hepatitis A Vaccine in Patients With Immunomodulating Drugs
Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate

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).

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Response to Hepatitis A Vaccine
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
May 2011
May 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Sweden
 
NCT01360970
EU 2009-016055-22
Yes
Lars Rombo, Sormland county council
Sormland County Council, Sweden
Not Provided
Principal Investigator: lars rombo, MD Karolinska Institutet
Sormland County Council, Sweden
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP