Immunogenicity and Safety of Vaccinations in Immunocompromised Persons

Condition(s) targeted: Arthritis, Rheumatoid; Spondylarthritis; Vasculitis

Intervention: Hepatitis A vaccine and tetanus vaccine (Biological)

Phase: N/A

Status: Recruiting

Sponsored by: University of Zurich

Official(s) and/or principal investigator(s):
Christoph Hatz, Professor, Principal Investigator, Affiliation: University of Zurich, Epidemiology, Biostatistics and Prevention Institute

Overall contact:
Christoph Hatz, Professor, Phone: + 41 794235036, Email: christoph.hatz@uzh.ch

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.

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 design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Immunogenicity of hepatitis A and tetanus vaccination in patients with rheumatoid arthritis, axial spondyloarthritis and vasculitis and in healthy controls

Secondary outcome: Safety of tetanus and hepatitis A vaccines in patients with rheumatoid arthritis, axial spondyloarthritis and vasculitis and 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.

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

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

Christoph Hatz, Professor, Phone: + 41 794235036, Email: christoph.hatz@uzh.ch

University of Bern, Inselspital, Division of Infectious Diseases and Travel Medicine, Bern 3010, Switzerland; Recruiting
Hansjakob Furrer, Professor, Phone: + 41 (0) 31 632, Ext: 27 45, Email: Hansjakob.Furrer@insel.ch
Cornelia Staehelin, MD, Phone: + 41 (0) 31 632, Ext: 27 45, Email: Cornelia.Staehelin@insel.ch
Hansjakob Furrer, Professor, Principal Investigator

University of Bern, Inselspital, Division of Rheumatology, Bern 3010, Switzerland; Recruiting
Peter Villiger, Professor, Phone: +41 (0)31 632, Ext: 31 70, Email: Peter.Villiger@insel.ch
Peter Villiger, Professpr, Principal Investigator

University of Geneva, University Hospitals, Division of Rheumatology, Geneva 1211, Switzerland; Recruiting
Cem Gabay, Professor, Phone: +41 (0) 22-382, Ext: 3500, Email: Cem.Gabay@hcuge.ch
Cem Gabay, Professor, Principal Investigator

University of Geneva, University Hospitals, Service de Médecine Tropicale et Humanitaire, Geneva 1211, Switzerland; Recruiting
François Chappuis, Professor, Phone: +41 (0) 22 372, Ext: 9615, Email: Francois.Chappuis@hcuge.ch
François Chappuis, Professor, Principal Investigator

Cantonal Hospital St. Gallen, Division of Rheumatology, St. Gallen 9007, Switzerland; Recruiting
Rüdiger Müller, MD, Phone: + 41 (0) 71-494, Ext: 1132, Email: Ruediger.Mueller@kssg.ch
Rüdiger Müller, MD, Principal Investigator

University of Zurich, Epidemiology, Biostatistics and Prevention Institute, Divison of Infectious Diseases, Zürich 8001, Switzerland; Recruiting
Christoph Hatz, Professor, Phone: + 41 79 423 5036, Email: christoph.hatz@uzh.ch
Silja Bühler, MD, Phone: + 41 44 634, Ext: 4621
Hatz Christoph, Professor, Principal Investigator
Silja Bühler, MD, Sub-Investigator

University of Zurich, University Hopsital, Divison of Rheumatology, Zürich 8091, Switzerland; Recruiting
Adrian Ciurea, MD PD, Phone: +41 (0)44 255, Ext: 2958, Email: adrian.ciurea@usz.ch
Adrian Ciurea, PD, Principal Investigator

Cantonal Hospital Aarau, Division of Rheumatology, Aarau, Aargau 5001, Switzerland; Recruiting
Paul Hasler, Professor, Phone: + 41 (0) 62 838, Ext: 46 92, Email: paul.hasler@ksa.ch
Juliane Franz, MD, Phone: + 41 (0) 62 838, Ext: 46 88, Email: juliane.franz@ksa.ch
Paul Hasler, Professor, Principal Investigator
Juline Franz, MD, Sub-Investigator

Swiss Tropical and Public Health Institute, Basel, Basel Town 4051, Switzerland; Recruiting
Christoph Hatz, Professor, Phone: +41 61 284, Ext: 81 11, Email: christoph.hatz@unibas.ch
Andreas Neumayr, MD, Phone: +41 61 284, Ext: 81 11, Email: andreas.neumayr@unibas.ch
Christoph Hatz, Professor, Principal Investigator

University Hospital of Basel, Rheumatology Division, Basel, Basel Town 4031, Switzerland; Recruiting
Ulrich Walker, Professor, Phone: +41 61 326, Ext: 42 22, Email: ulrich.walker@usb.ch
Ulrich Walker, Professor, Principal Investigator

Vaccination recommendations in immunocompromised travelers by the Centers for Disease Control and Prevention

Vaccination recommendations in immunocompromised persons, Belgium

Canadian vaccination recommendations in immunocompromised persons

Vaccination recommendation for patients with rheumatic disease, Swiss society of rheumatology

Related publications:

van Assen S, Elkayam O, Agmon-Levin N, Cervera R, Doran MF, Dougados M, Emery P, Geborek P, Ioannidis JP, Jayne DR, Kallenberg CG, Müller-Ladner U, Shoenfeld Y, Stojanovich L, Valesini G, Wulffraat NM, Bijl M. Vaccination in adult patients with auto-immune inflammatory rheumatic diseases: a systematic literature review for the European League Against Rheumatism evidence-based recommendations for vaccination in adult patients with auto-immune inflammatory rheumatic diseases. Autoimmun Rev. 2011 Apr;10(6):341-52. doi: 10.1016/j.autrev.2010.12.003. Epub 2010 Dec 20. Review.

Bijl M, Kallenberg CG, van Assen S. Vaccination of the immune-compromised patients with focus on patients with autoimmune-inflammatory diseases. Neth J Med. 2011 Jan;69(1):5-13. Review.

Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum. 2002 Sep;46(9):2287-93.

Bernatsky S, Hudson M, Suissa S. Anti-rheumatic drug use and risk of serious infections in rheumatoid arthritis. Rheumatology (Oxford). 2007 Jul;46(7):1157-60. Epub 2007 May 3.

Kotton CN. Vaccination and immunization against travel-related diseases in immunocompromised hosts. Expert Rev Vaccines. 2008 Jul;7(5):663-72. doi: 10.1586/14760584.7.5.663. Review.

Rahier JF, Moutschen M, Van Gompel A, Van Ranst M, Louis E, Segaert S, Masson P, De Keyser F. Vaccinations in patients with immune-mediated inflammatory diseases. Rheumatology (Oxford). 2010 Oct;49(10):1815-27. doi: 10.1093/rheumatology/keq183. Epub 2010 Jun 29. Review.

Steffen R, Kane MA, Shapiro CN, Billo N, Schoellhorn KJ, van Damme P. Epidemiology and prevention of hepatitis A in travelers. JAMA. 1994 Sep 21;272(11):885-9.

Agarwal N, Ollington K, Kaneshiro M, Frenck R, Melmed GY. Are immunosuppressive medications associated with decreased responses to routine immunizations? A systematic review. Vaccine. 2012 Feb 14;30(8):1413-24. doi: 10.1016/j.vaccine.2011.11.109. Epub 2011 Dec 21. Review.

Starting date: October 2013
Last updated: June 2, 2015