Hepatitis A Vaccine in Patients With Immunomodulating Drugs
This study has been completed.
Sponsor:
Sormland County Council, Sweden
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
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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: 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 Sormland County Council, Sweden:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| 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:
Detailed Description:
-
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
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Sormland County Council, Sweden
Investigators
| Principal Investigator: | lars rombo, MD | Karolinska Institutet |
More Information
No publications provided
| Responsible Party: | Lars Rombo, Sormland county council |
| ClinicalTrials.gov Identifier: | NCT01360970 History of Changes |
| Other Study ID Numbers: | EU 2009-016055-22 |
| Study First Received: | May 24, 2011 |
| Last Updated: | May 25, 2011 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by Sormland County Council, Sweden:
|
hepatitis A vaccine TNF-alfa inhibitory drugs Rheumatoid arthritis methotrexate |
Additional relevant MeSH terms:
|
Arthritis, Rheumatoid Hepatitis Hepatitis A Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013