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Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Primary Purpose

Vaccine Response Impaired

Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
hepatitis A vaccine
hepatitis A vaccine
Sponsored by
Sormland County Council, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaccine Response Impaired 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 methotrexate 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-, hen-protein- 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
  • Department of infectious diseases
  • Dept infectious diseases
  • Dept infectious diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

initial single dose of hep A vaccine

initial double dose

Arm Description

The participants will receive a single dose of hepatitis A vaccine at 0+1+6 months

Participants will receive one dose of hepatitis A vaccine in each M. deltoids and an additional dose at 6 months later

Outcomes

Primary Outcome Measures

seroconversion after the first dose/doses of hepatitis A vaccine
ELISA-titers are determined before the first dose/doses and at 1 month later

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2011
Last Updated
November 17, 2015
Sponsor
Sormland County Council, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01446978
Brief Title
Three Doses of 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
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sormland County Council, Sweden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hepatitis A vaccine is the most frequently used traveler's vaccine, yet data on its ability to induce protective immunity in immunosuppressed travelers 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). In a previous study, 2 doses were not considered effective and there is therefore need for a study with an additional dose
Detailed Description
Methods: Parameters registered at baseline were: age, sex, duration of disease, medications, activity of disease (Visual Analogue Scale), Health Assessment Questionnaire Disability Index, Disease Activity Score, Acute phase reactant and total immunoglobulin G 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
Vaccine Response Impaired
Keywords
hepatitis A vaccine, TNF-alfa inhibitory drugs, Rheumatoid arthritis, methotrexate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
initial single dose of hep A vaccine
Arm Type
Active Comparator
Arm Description
The participants will receive a single dose of hepatitis A vaccine at 0+1+6 months
Arm Title
initial double dose
Arm Type
Active Comparator
Arm Description
Participants will receive one dose of hepatitis A vaccine in each M. deltoids and an additional dose at 6 months later
Intervention Type
Biological
Intervention Name(s)
hepatitis A vaccine
Intervention Description
3 doses of hepatitis A vaccine, given at 0+1+6 months
Intervention Type
Biological
Intervention Name(s)
hepatitis A vaccine
Intervention Description
Two doses of hepatitis A vaccine given at day 0, one in each M deltoids. An additional dose will be given at 6 months later
Primary Outcome Measure Information:
Title
seroconversion after the first dose/doses of hepatitis A vaccine
Description
ELISA-titers are determined before the first dose/doses and at 1 month later
Time Frame
one month after the first dose/doses
Secondary Outcome Measure Information:
Title
seroconversion rates after three doses of hepatitis A vaccine
Description
We determine seroconversion rates before the third vaccine dose (6 months after the first) and at 1 and 6 months after the second dose
Time Frame
12 months after the first doses

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 methotrexate 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-, hen-protein- 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
Eskilstuna
ZIP/Postal Code
631 88
Country
Sweden
Facility Name
Department of infectious diseases
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Dept infectious diseases
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Dept infectious diseases
City
Örebro
ZIP/Postal Code
70185
Country
Sweden

12. IPD Sharing Statement

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Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

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