Arthritis, Rheumatoid Clinical Trial
Official title:
A Prospective Cohort Study in 6 Swiss Rheumatology Centres and 4 Travel Clinics on the Immunogenicity and Safety of Tetanus and Hepatitis A Vaccine in Patients With Rheumatoid Arthritis, Axial Spondyloarthritis and Vasculitis and Healthy Controls
Backgound and relevance of the project:
Patients with autoimmune inflammatory rheumatic diseases (AIIRD) are at increased risk of
contracting infections. The increased risk can be attributed to the immunological disorder
itself, as well as to the immunosuppressive treatment. Vaccination against many infections
is recommended in this patient group. However, the immunogenicity of vaccines may be reduced
and may also be influenced by the administered treatment. Potential reactivation of the
underlying disease triggered by vaccination is another important concern.
From the patients' and public health perspectives, an important task of physicians is giving
advice on vaccines. Completing this task is often difficult, because data on the
immunogenicity and safety of vaccines in these patient groups are scarce, especially with
regard to treatment with new immunosuppressive medications, such as biological agents.
Lastly and importantly, due to new therapeutic options, health among AIIRD patients has
considerably improved and an increasing number of patients undertake overseas travel
activities requiring additional vaccinations. In this context, reliable advice with regard
to vaccinations is almost impossible, because for most travel vaccinations the
immunogenicity and safety profile is unknown.
Research addressing the immunogenicity and safety of vaccines in different autoimmune
inflammatory diseases treated with different immunosuppressive medications is urgently
needed to allow giving evidence based vaccine advice.
In this observational study the immunogenicity and safety of tetanus booster and hepatitis A
vaccinations will be assessed in AIIRD patients. The immune response will be evaluated as a
function of the underlying disease and the possible influence of commonly used
immunosuppressive drugs on the immune response will be studied.
Rationale for studying tetanus booster and hepatitis A vaccine Tetanus vaccination is one of
the most frequently recommended vaccinations, and the effect of a booster vaccination can be
addressed. Hepatitis A vaccine is the most widely used travel vaccine. Despite their
importance, only very limited data are available for tetanus and hepatitis A vaccine in this
patient group. By focusing on these vaccines the study will lead the way to the evaluation
of further vaccines.
The purpose of this study is to determine whether tetanus and hepatitis A vaccinations are
as immunogenic and safe in AIIRD patients as in healthy controls.
The study will be placed in 6 rheumatology clinics in Switzerland and in 4 travel medicine clinics. Consecutive subjects with rheumatoid arthritis, spondylarthritis (ankylosing spondylitis), vasculitis (ANCA associated vasculitis and Behçet's disease) and healthy controls will be recruited. ;
Observational Model: Cohort, Time Perspective: Prospective
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