Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Vaccine Response Impaired Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01446978
• Other study ID #: Rombo - 2
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 3, 2011
• Last updated: November 17, 2015
• Start date: September 2011
• Est. completion date: August 2016

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 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Vaccine Response Impaired

Intervention

Biological:
• hepatitis A vaccine
3 doses of hepatitis A vaccine, given at 0+1+6 months
• 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

Locations

Country	Name	City	State
Sweden	Dept infectious diseases	Eskilstuna
Sweden	Dept infectious diseases	Örebro
Sweden	Department of infectious diseases	Stockholm
Sweden	Dept infectious diseases	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Sormland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

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