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Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Primary Purpose

Response to Hepatitis A Vaccine

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
hepatitis A vaccine ( HAVRIX or EPAXAL)
Sponsored by
Lars Rombo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Response to Hepatitis A Vaccine focused on measuring hepatitis A vaccine, TNF-alfa inhibitory drugs, Rheumatoid arthritis, methotrexate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Dept infectious diseases
  • Dept infectious diseases
  • Dept infectious diseases
  • Department of infectious diseases

Outcomes

Primary Outcome Measures

seroconversion after a single dose of hepatitis A vaccine
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
We determine seroconversion rates before the second vaccine dose ( 6 months after the first) and at 1 and 6 months after the second dose

Full Information

First Posted
May 24, 2011
Last Updated
November 17, 2015
Sponsor
Lars Rombo
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1. Study Identification

Unique Protocol Identification Number
NCT01360970
Brief Title
Hepatitis A Vaccine in Patients With Immunomodulating Drugs
Official Title
Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lars Rombo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Response to Hepatitis A Vaccine
Keywords
hepatitis A vaccine, TNF-alfa inhibitory drugs, Rheumatoid arthritis, methotrexate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
hepatitis A vaccine ( HAVRIX or EPAXAL)
Intervention Description
1.0 ml im ( Havrix) and 0.5 ml im (Epaxal. Both vaccines are given two times with 6 months interval
Primary Outcome Measure Information:
Title
seroconversion after a single dose of hepatitis A vaccine
Description
ELISA-titers are determined before first dose and at 1 and 6 months later
Time Frame
one month after dose
Secondary Outcome Measure Information:
Title
seroconversion rates after a second dose of hepatitis A vaccine
Description
We determine seroconversion rates before the second vaccine dose ( 6 months after the first) and at 1 and 6 months after the second dose
Time Frame
12 monrths

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lars rombo, MD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept infectious diseases
City
Helsingfors
ZIP/Postal Code
00029
Country
Finland
Facility Name
Dept infectious diseases
City
Eskilstuna
ZIP/Postal Code
631 88
Country
Sweden
Facility Name
Dept infectious diseases
City
Karlstad
ZIP/Postal Code
651 85
Country
Sweden
Facility Name
Department of infectious diseases
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

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Hepatitis A Vaccine in Patients With Immunomodulating Drugs

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