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Immunogenicity and Safety of Vaccinations in Immunocompromised Persons

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Zurich
Sponsor:
Collaborators:
University of Basel
Swiss Tropical & Public Health Institute
University of Bern
University Hospital, Geneva
Cantonal Hospital of St. Gallen
Cantonal Hospital of Aarau, Switzerland
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01947465
First received: August 22, 2013
Last updated: May 18, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Arthritis, Rheumatoid
Spondylarthritis
Vasculitis
Biological: Hepatitis A vaccine and tetanus vaccine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Immunogenicity of hepatitis A and tetanus vaccination in patients with rheumatoid arthritis, axial spondyloarthritis and vasculitis and in healthy controls [ Time Frame: Change from Baseline in geometric mean antibody titre and seroprotection at 4 weeks and at 12 weeks ] [ Designated as safety issue: No ]
    comparison of the geometric mean antibody titre and percentage of seroprotected individuals after tetanus and hepatitis A vaccination between each disease group and healthy controls


Secondary Outcome Measures:
  • Safety of tetanus and hepatitis A vaccines in patients with rheumatoid arthritis, axial spondyloarthritis and vasculitis and in healthy controls [ Time Frame: Activation of rheumatic disease will be assessed for 1 week after vaccine administration and at 4 and 12 weeks compared to baseline ] [ Designated as safety issue: Yes ]

    Number of patients with any worsening or reactivation of the rheumatic disease after vaccine administration

    Number of participants with adverse vaccine reactions (local and systemic reactions) in patients with rheumatoid arthritis, axial spondyloarthritis and vasculitis and in healthy controls



Biospecimen Retention:   Samples Without DNA

Sera from participants will be kept in a biobank for further measurements of antibody responses after vaccination.


Estimated Enrollment: 745
Study Start Date: October 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy controls
If a vaccination is indicated according to the recommendations by the Swiss Federal Office of Public Health: 319 healthy controls will be enrolled and will receive hepatitis A and/or tetanus vaccination
Biological: Hepatitis A vaccine and tetanus vaccine
Hepatitis A and/or tetanus vaccination will be given to participants in all group on day 0. All monovalent active hepatitis A vaccinations and all vaccines containing tetanus toxoid available in Switzerland may be used in the study
Other Names:
  • Havrix 1440
  • Epaxal
  • Td-Pur
  • Boostrix
  • BoostrixPolio
  • Revaxis
Patients with rheumatoid arthritis
If a vaccination is indicated according to the recommendations by the Swiss Federal Office of Public Health: 142 patients with rheumatoid arthritis will be enrolled and will receive hepatitis A and/or tetanus vaccination.
Biological: Hepatitis A vaccine and tetanus vaccine
Hepatitis A and/or tetanus vaccination will be given to participants in all group on day 0. All monovalent active hepatitis A vaccinations and all vaccines containing tetanus toxoid available in Switzerland may be used in the study
Other Names:
  • Havrix 1440
  • Epaxal
  • Td-Pur
  • Boostrix
  • BoostrixPolio
  • Revaxis
Patients with axial spondylarthritis
If a vaccination is indicated according to the recommendations by the Swiss Federal Office of Public Health: 142 patients with axial spondylarthritis will be enrolled and will receive hepatitis A and/or tetanus vaccination.
Biological: Hepatitis A vaccine and tetanus vaccine
Hepatitis A and/or tetanus vaccination will be given to participants in all group on day 0. All monovalent active hepatitis A vaccinations and all vaccines containing tetanus toxoid available in Switzerland may be used in the study
Other Names:
  • Havrix 1440
  • Epaxal
  • Td-Pur
  • Boostrix
  • BoostrixPolio
  • Revaxis
Patients with vasculitis
If a vaccination is indicated according to the recommendations by the Swiss Federal Office of Public Health: 142 patients with vasculitis will be enrolled and will receive hepatitis A and/or tetanus vaccination.
Biological: Hepatitis A vaccine and tetanus vaccine
Hepatitis A and/or tetanus vaccination will be given to participants in all group on day 0. All monovalent active hepatitis A vaccinations and all vaccines containing tetanus toxoid available in Switzerland may be used in the study
Other Names:
  • Havrix 1440
  • Epaxal
  • Td-Pur
  • Boostrix
  • BoostrixPolio
  • Revaxis

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)

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)) 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947465

Contacts
Contact: Christoph Hatz, Professor + 41 794235036 christoph.hatz@ifspm.uzh.ch
Contact: Silja Bühler, MD + 41 44 634 ext 4621 silja.buehler@ifspm.uzh.ch

Locations
Switzerland
Cantonal Hospital Aarau, Division of Rheumatology Recruiting
Aarau, Aargau, Switzerland, 5001
Contact: Paul Hasler, Professor    + 41 (0) 62 838 ext 46 92    paul.hasler@ksa.ch   
Contact: Juliane Franz, MD    + 41 (0) 62 838 ext 46 88    juliane.franz@ksa.ch   
Principal Investigator: Paul Hasler, Professor         
Sub-Investigator: Juline Franz, MD         
Swiss Tropical and Public Health Institute Recruiting
Basel, Basel Town, Switzerland, 4051
Contact: Christoph Hatz, Professor    +41 61 284 ext 81 11    christoph.hatz@unibas.ch   
Contact: Andreas Neumayr, MD    +41 61 284 ext 81 11    andreas.neumayr@unibas.ch   
Principal Investigator: Christoph Hatz, Professor         
University Hospital of Basel, Rheumatology Division Recruiting
Basel, Basel Town, Switzerland, 4031
Contact: Ulrich Walker, Professor    +41 61 326 ext 42 22    ulrich.walker@usb.ch   
Principal Investigator: Ulrich Walker, Professor         
University of Bern, Inselspital, Division of Infectious Diseases and Travel Medicine Recruiting
Bern, Switzerland, 3010
Contact: Hansjakob Furrer, Professor    + 41 (0) 31 632 ext 27 45    Hansjakob.Furrer@insel.ch   
Contact: Cornelia Staehelin, MD    + 41 (0) 31 632 ext 27 45    Cornelia.Staehelin@insel.ch   
Principal Investigator: Hansjakob Furrer, Professor         
University of Bern, Inselspital, Division of Rheumatology Recruiting
Bern, Switzerland, 3010
Contact: Peter Villiger, Professor    +41 (0)31 632 ext 31 70    Peter.Villiger@insel.ch   
Principal Investigator: Peter Villiger, Professpr         
University of Geneva, University Hospitals, Division of Rheumatology Recruiting
Geneva, Switzerland, 1211
Contact: Cem Gabay, Professor    +41 (0) 22-382 ext 3500    Cem.Gabay@hcuge.ch   
Principal Investigator: Cem Gabay, Professor         
University of Geneva, University Hospitals, Divison of Humanitarian and Travel Medicine Recruiting
Geneva, Switzerland, 1211
Contact: Louis Loutan, Professor    +41 (0) 22 372 ext 9615    Louis.Loutan@hcuge.ch   
Principal Investigator: Louis Loutan, Professor         
Cantonal Hospital St. Gallen, Division of Rheumatology Recruiting
St. Gallen, Switzerland, 9007
Contact: Rüdiger Müller, MD    + 41 (0) 71-494 ext 1132    Ruediger.Mueller@kssg.ch   
Principal Investigator: Rüdiger Müller, MD         
University of Zurich, Institute of Social and Preventive Medicine, Divison of Epidemiology and Prevention of Communicable Diseases Recruiting
Zürich, Switzerland, 8001
Contact: Christoph Hatz, Professor    + 41 79 423 5036    christoph.hatz@ifspm.uzh.ch   
Contact: Silja Bühler, MD    + 41 44 634 ext 4621      
Principal Investigator: Hatz Christoph, Professor         
Sub-Investigator: Silja Bühler, MD         
University of Zurich, University Hopsital, Divison of Rheumatology Recruiting
Zürich, Switzerland, 8091
Contact: Adrian Ciurea, MD PD    +41 (0)44 255 ext 2958    adrian.ciurea@usz.ch   
Principal Investigator: Adrian Ciurea, PD         
Sponsors and Collaborators
University of Zurich
University of Basel
Swiss Tropical & Public Health Institute
University of Bern
University Hospital, Geneva
Cantonal Hospital of St. Gallen
Cantonal Hospital of Aarau, Switzerland
Investigators
Principal Investigator: Christoph Hatz, Professor University of Zurich, Institute of Social and Preventive Medicine
  More Information

Additional Information:
Publications:

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01947465     History of Changes
Other Study ID Numbers: CS_2013_01
Study First Received: August 22, 2013
Last Updated: May 18, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Spondylarthritis
Vasculitis
Autoimmune Diseases
Bone Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spinal Diseases
Spondylitis
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014