Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Response to Hepatitis A Vaccine Clinical Trial

Official title:

Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360970
• Other study ID #: EU 2009-016055-22
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2011
• Last updated: November 17, 2015
• Start date: September 2009
• Est. completion date: May 2011

Study information

• Verified date: November 2015
• Source: Sormland County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

Hepatitis A vaccine is the most frequently used traveller's vaccine, yet data on its ability to induce protective immunity in immunosuppressed travellers 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).

Description:

Methods: Parameters registered at baseline were: age, sex, duration of disease, medications, activity of disease (Visual Analogue Scale=VAS, Health Assessment Questionnaire Disability Index = HAQ, Disease Activity Score =DAS-28, CRP and total IgG 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of rheumatoid arthritis

• TNF-alfa blocker and / or methotraxate 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-, henprotein- 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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Response to Hepatitis A Vaccine

Intervention

Biological:
• hepatitis A vaccine ( HAVRIX or EPAXAL)
1.0 ml im ( Havrix) and 0.5 ml im (Epaxal. Both vaccines are given two times with 6 months interval

Locations

Country	Name	City	State
Finland	Dept infectious diseases	Helsingfors
Sweden	Dept infectious diseases	Eskilstuna
Sweden	Dept infectious diseases	Karlstad
Sweden	Department of infectious diseases	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Lars Rombo

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seroconversion after a single dose of hepatitis A vaccine	ELISA-titers are determined before first dose and at 1 and 6 months later	one month after dose	No
Secondary	seroconversion rates after a second dose of hepatitis A vaccine	We determine seroconversion rates before the second vaccine dose ( 6 months after the first) and at 1 and 6 months after the second dose	12 monrths	No