Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs - Full Text View

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 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:

Genetics Home Reference related topics: rheumatoid arthritis

MedlinePlus related topics: Hepatitis Hepatitis A

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Lars Rombo, 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 ]
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 ]
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)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on July 27, 2017