Overview

This trial is active, not recruiting.

Condition vaccine response impaired
Treatments hepatitis a vaccine
Phase phase 2
Sponsor Sormland County Council, Sweden
Start date September 2011
End date August 2016
Trial size 150 participants
Trial identifier NCT01446978, Rombo - 2

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
The participants will receive a single dose of hepatitis A vaccine at 0+1+6 months
hepatitis a vaccine
3 doses of hepatitis A vaccine, given at 0+1+6 months
(Active Comparator)
Participants will receive one dose of hepatitis A vaccine in each M. deltoids and an additional dose at 6 months later
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

Primary Outcomes

Measure
seroconversion after the first dose/doses of hepatitis A vaccine
time frame: one month after the first dose/doses

Secondary Outcomes

Measure
seroconversion rates after three doses of hepatitis A vaccine
time frame: 12 months after the first doses

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate
Principal investigator lars rombo, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Sormland County Council, Sweden.