Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs
This study is ongoing, but not recruiting participants.
Sponsor:
Sormland County Council, Sweden
Information provided by (Responsible Party):
Lars Rombo, Sormland County Council, Sweden
ClinicalTrials.gov Identifier:
NCT01446978
First received: October 3, 2011
Last updated: November 17, 2015
Last verified: November 2015
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Vaccine Response Impaired |
Biological: hepatitis A vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel 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 the first dose/doses of hepatitis A vaccine [ Time Frame: one month after the first dose/doses ] [ Designated as safety issue: No ]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 [ Time Frame: 12 months after the first doses ] [ Designated as safety issue: No ]We determine seroconversion rates before the third vaccine dose (6 months after the first) and at 1 and 6 months after the second dose
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: initial single dose of hep A vaccine
The participants will receive a single dose of hepatitis A vaccine at 0+1+6 months
|
Biological: hepatitis A vaccine
3 doses of hepatitis A vaccine, given at 0+1+6 months
|
|
Active Comparator: initial double dose
Participants will receive one dose of hepatitis A vaccine in each M. deltoids and an additional dose at 6 months later
|
Biological: hepatitis A vaccine
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01446978
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446978
Locations
| Sweden | |
| Dept infectious diseases | |
| Eskilstuna, Sweden, 631 88 | |
| Department of infectious diseases | |
| Stockholm, Sweden, 17176 | |
| Dept infectious diseases | |
| Uppsala, Sweden, 75185 | |
| Dept infectious diseases | |
| Örebro, Sweden, 70185 | |
Sponsors and Collaborators
Sormland County Council, Sweden
Investigators
| Principal Investigator: | lars rombo, MD | Karolinska Institutet |
More Information
| Responsible Party: | Lars Rombo, Professor, Sormland County Council, Sweden |
| ClinicalTrials.gov Identifier: | NCT01446978 History of Changes |
| Other Study ID Numbers: | Rombo - 2 |
| Study First Received: | October 3, 2011 |
| Last Updated: | November 17, 2015 |
| 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:
|
Hepatitis Hepatitis A Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Vaccines Methotrexate Immunologic Factors Physiological Effects of Drugs |
Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on September 27, 2016