Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Vaccine Response Impaired	Biological: hepatitis A vaccine	Phase 2

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate
Study Start Date :	September 2011
Estimated Primary Completion Date :	August 2016
Estimated Study Completion Date :	August 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. seroconversion after the first dose/doses of hepatitis A vaccine [ Time Frame: one month after the first dose/doses ]
   ELISA-titers are determined before the first dose/doses and at 1 month later

Secondary Outcome Measures :

1. seroconversion rates after three doses of hepatitis A vaccine [ Time Frame: 12 months after the first doses ]
   We determine seroconversion rates before the third vaccine dose (6 months after the first) and at 1 and 6 months after the second dose

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Lars Rombo, Professor, Sormland County Council, Sweden
ClinicalTrials.gov Identifier:	NCT01446978 History of Changes
Other Study ID Numbers:	Rombo - 2
First Posted:	October 5, 2011
Last Update Posted:	November 18, 2015
Last Verified:	November 2015

Keywords provided by Lars Rombo, 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