Clinical trial NCT01947465: Immunogenicity and Safety of Vaccinations in Immunocompromised Persons
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Spondylarthritis
Vasculitis
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Swiss Tropical & Public Health Institute
name: University of Bern
name: University Hospital, Geneva
name: Cantonal Hospital of St. Gallen
name: Cantonal Hospital of Aarau, Switzerland
First posted: 2013-09-20
Enrollment: 645
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cohort will be selected from patients with rheumatic diseases under treatment at 6 rheumatology outpatient clinics in Switzerland (University of Basel, University of Bern, University of Geneva, University of Zurich, Cantonal Hospital Aarau, Cantonal Hospital St. Gallen)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Indication for hepatitis A and/or tetanus vaccination according to Swiss Federal Office of Public Health recommendations
* Male and female rheumatic patients with rheumatoid arthritis or axial spondyloarthritis (ankylosing spondylitis, axial psoriatic arthritis, axial undifferentiated spondyloarthritis, enteropahtic arthritis) or peripheral psoriatic arthritis or vasculitis (Behçet's disease or ANCA-associated vasculitis) or male and female healthy participants ≥ 18 years
* Signed Informed Consent after being informed

Exclusion Criteria:

* Known hypersensitivity to a vaccine ingredient
* Estimated patient survival below 1 year
* Active malignant or active infectious disease
* Drug/alcohol abuse
* Insufficient understanding of local language

Primary outcomes:
measure: Immunogenicity of hepatitis A and tetanus vaccination in patients with rheumatoid arthritis, axial spondyloarthritis and vasculitis and in healthy controls
timeFrame: Change from Baseline in geometric mean antibody titre and seroprotection at 4 weeks and at 12 weeks
Secondary outcomes:
measure: Safety of tetanus and hepatitis A vaccines in patients with rheumatoid arthritis, axial spondyloarthritis and vasculitis and in healthy controls
timeFrame: Activation of rheumatic disease will be assessed for 1 week after vaccine administration and at 4 and 12 weeks compared to baseline
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Cantonal Hospital Aarau, Division of Rheumatology
state: Aargau
city: Basel
country: Switzerland
facility: University Hospital of Basel, Rheumatology Division
state: Basel Town
city: Basel
country: Switzerland
facility: Swiss Tropical and Public Health Institute
state: Basel Town
city: Bern
country: Switzerland
facility: University of Bern, Inselspital, Division of Infectious Diseases and Travel Medicine
city: Bern
country: Switzerland
facility: University of Bern, Inselspital, Division of Rheumatology
city: Geneva
country: Switzerland
facility: University of Geneva, University Hospitals, Division of Rheumatology
city: Geneva
country: Switzerland
facility: University of Geneva, University Hospitals, Service de Médecine Tropicale et Humanitaire
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital St. Gallen, Division of Rheumatology
city: Zürich
country: Switzerland
facility: University of Zurich, Epidemiology, Biostatistics and Prevention Institute, Divison of Infectious Diseases
city: Zürich
country: Switzerland
facility: University of Zurich, University Hopsital, Divison of Rheumatology
Study officials:
affiliation: University of Zurich
name: Christoph Hatz, Professor
role: PRINCIPAL_INVESTIGATOR
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