Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Condition(s) targeted: Vaccine Response Impaired

Intervention: hepatitis A vaccine (Biological); hepatitis A vaccine (Biological)

Phase: Phase 2

Status: Recruiting

Sponsored by: Sormland County Council, Sweden

Official(s) and/or principal investigator(s):
lars rombo, MD, Principal Investigator, Affiliation: Karolinska Institutet

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

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

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

Primary outcome: seroconversion after the first dose/doses of hepatitis A vaccine

Secondary outcome: seroconversion rates after three doses of hepatitis A vaccine

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Dept infectious diseases, Eskilstuna 631 88, Sweden; Recruiting
lars rombo, MD, Phone: +4616103551, Email: lars.rombo@dll.se
lars rombo, Professor, Principal Investigator

Department of infectious diseases, Stockholm 17176, Sweden; Recruiting
Helena Hervius, MD PhD, Email: helena.hervius-askling@karolinska.se
Helena Hervius-Askling, MD PhD, Principal Investigator

Dept infectious diseases, Uppsala 75185, Sweden; Recruiting
Karlis Pauksens, Assoc. prof., Phone: +46186110000

Dept infectious diseases, Örebro 70185, Sweden; Recruiting
Torbjörn Norén, MD, PhD, Phone: +4619-6022200, Email: torbjorn.noren@orebroll.se

Starting date: September 2011
Last updated: November 19, 2014