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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 24, 2011

Last Updated Date

May 25, 2011

Start Date ^ICMJE

September 2009

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01360970 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Official Title ^ICMJE

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

Brief Summary

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).

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Response to Hepatitis A Vaccine

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland, Sweden

Administrative Information

NCT Number ^ICMJE

NCT01360970

Other Study ID Numbers ^ICMJE

EU 2009-016055-22

Has Data Monitoring Committee

Yes

Responsible Party

Lars Rombo, Sormland county council

Study Sponsor ^ICMJE

Sormland County Council, Sweden

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

lars rombo, MD

Karolinska Institutet

Information Provided By

Sormland County Council, Sweden

Verification Date

May 2011

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

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