This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

HomeBrowseAboutFAQs
Log In
Sign Up
Vaccine Response Impaired

Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Sponsored by Sormland County Council, Sweden

About this trial

Last updated 10 years ago

Study ID

Rombo - 2

Status

Unknown status

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 9 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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 -

No

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)