Yellow Fever Vaccination Under Low Dose Methotrexate Therapy

NCT02383680 | Unknown

• 1 other identifier: CS_2014_01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 6

Brief Summary

Travelers (n = 30, 15 taking low-dose methotrexate (MTX), 15 healthy controls (HC), seeking travel advice in one of the following Swiss Travel Centers (Aarau, Basel, Bern, Geneva, Lausanne, Zurich) and who have an indication for yellow fever (YF) vaccination according to the Swiss Federal Office of Public Health's vaccination recommendations are invited to participate in this study. After signing the consent form (i) YF viremia and (ii) anti-YF antibody production in patients taking low-dose MTX and HC will be compared after YF vaccination. It will be analyzed whether the percentage of people with protective antibodies differs between the two groups and (iii) vaccine side effects will be compared between the groups.

Conditions

Rheumatic; Dermatologic Disorders

Keywords

Methotrexate therapy

Outcome Measures

Primary Outcomes (2)

• Quantitative viremia in blood in travelers under low dose methotrexate (≤20mg/week) and healthy travelers

  Serum samples will be collected for PCR

  days 3, 7, 10 and 14 and 28

• Quantitative yellow fever specific neutralizing antibodies in blood of travelers under low dose methotrexate therapy (≤20mg/week) and healthy travelers

  Serum samples will be collected for measurement of neutralizing antibodies

  days 0, 7, 10, 14 and 28

Secondary Outcomes (2)

• Determination of the percentage of travelers with an antibody level of >0.7 LNI (>0.5 IU/ml) in both groups

  days 0, 7, 10, 14, 28

• Assessment of safety by determining the severity and quantity of adverse vaccine reactions such as local and systemic reactions in both study groups

  Throughout day 28 after vaccination

Study Arms (2)

Patients under low dose methotrexate therapy

Patients with various underlying conditions (e.g. rheumatic diseases, dermatologic diseases) who have an indication for yellow fever vaccination

Biological: Yellow Fever Vaccination

Healthy controls

Healthy travelers who have an indication for yellow fever vaccination

Biological: Yellow Fever Vaccination

Interventions

Yellow Fever Vaccination BIOLOGICAL

The Yellow Fever vaccination is actually not part of the study. Only individuals who have an indication for yellow fever vaccination according to Swiss vaccination recommendations will be enrolled. Study procedures will include blood collection to measure antibody development and viremia as well as data collection on possible side effects.

Healthy controls; Patients under low dose methotrexate therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Travelers seeking pre-travel advice with an indication for yellow fever vaccination will be addressed in 6 Swiss Travel Clinics of the Cantonal Hospital Aarau, the University Hospital in Bern, the University of Zurich, teh University Hospital of Geneva and the Swiss Tropical and Public Health Instutute in Basel

You may qualify if:

• Informed Consent as documented by signature
• Indication for yellow fever vaccination according to Swiss FOPH recommendations
• Individuals under low dose MTX (≤20mg/week) therapy or healthy individuals
• Male and Female travelers ≥18 years to \<60 years of age

You may not qualify if:

• Contraindications on ethical grounds
• Women who are pregnant or breast feeding
• Contraindication against yellow fever vaccination (e.g. hypersensitivity against vaccine ingredient)
• Current treatment with other immunosuppressive agent apart from low dose methotrexate
• Alemtuzumab or rituximab in the last year
• TNF-blocking therapy in past three months
• Immunocompromising condition in healthy control
• Other immunocompromising condition than MTX treatment itself and the underlying disease in patients under MTX
• Previous yellow fever vaccination
• No indication for yellow fever vaccination according to Swiss travel vaccination recommendations
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

Sponsors & Collaborators

• University of Zurich: lead
• Swiss Tropical & Public Health Institute: collaborator
• Kantonsspital Aarau: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Hospital, Geneva: collaborator
• Centre Hospitalier Universitaire Vaudois: collaborator

Study Sites (6)

Kantonsspital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

RECRUITING

Swiss Tropical and Public Health Institute

Basel, Canton of Basel-City, 4051, Switzerland

RECRUITING

Universitätsklinik für Infektiologie Inselspital

Bern, Canton of Bern, 3010, Switzerland

NOT YET RECRUITING

Médecine Tropicale et Humanitaire Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, 1211, Switzerland

NOT YET RECRUITING

University of Zurich, Epidemiology, Biostatistics and Prevention Institute

Zurich, Canton of Zurich, 8001, Switzerland

RECRUITING

PMU | Policlinique médicale universitaire CHUV | Service des maladies infectieuses, Département de médecine

Lausanne, 1011, Switzerland

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Christoph Hatz, Prof MD

  University of Zurich, Epidemiolgy, Biostatistics and Prevention Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silja Bühler, MD MSc

CONTACT

+41 44634; silja.buehler@ifspm.uzh.ch

Christoph Hatz, Prof MD

CONTACT

+41 44634; christoph.hatz@unibas.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 9, 2015
• Study Start: December 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 9, 2015

Record last verified: 2015-03

Locations

CH (6)