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Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Sormland County Council, Sweden
Sponsor:
Information provided by (Responsible Party):
Lars Rombo, Sormland County Council, Sweden
ClinicalTrials.gov Identifier:
NCT01446978
First received: October 3, 2011
Last updated: November 19, 2014
Last verified: November 2014
History of Changes
  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:

U.S. FDA Resources

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: May 2015 (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
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
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 Recruiting
Eskilstuna, Sweden, 631 88
Contact: lars rombo, MD    +4616103551    lars.rombo@dll.se   
Principal Investigator: lars rombo, Professor         
Department of infectious diseases Recruiting
Stockholm, Sweden, 17176
Contact: Helena Hervius, MD PhD       helena.hervius-askling@karolinska.se   
Principal Investigator: Helena Hervius-Askling, MD PhD         
Dept infectious diseases Recruiting
Uppsala, Sweden, 75185
Contact: Karlis Pauksens, Assoc. prof.    +46186110000      
Dept infectious diseases Recruiting
Örebro, Sweden, 70185
Contact: Torbjörn Norén, MD, PhD    +4619-6022200    torbjorn.noren@orebroll.se   
Sponsors and Collaborators
Sormland County Council, Sweden
Investigators
Principal Investigator: lars rombo, MD Karolinska Institutet
  More Information

No publications provided

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 19, 2014
Health Authority: Sweden: Medical Products Agency

Keywords provided by Sormland County Council, Sweden:
hepatitis A vaccine
TNF-alfa inhibitory drugs
Rheumatoid arthritis
methotrexate

ClinicalTrials.gov processed this record on February 27, 2015