Yellow Fever Vaccination Under Low Dose Methotrexate Therapy (MTX_YF)

March 3, 2015 updated by: University of Zurich

Yellow Fever Vaccination Under Low Dose Methotrexate Therapy - a Multi-Center Prospective Observational Controlled Pilot Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in the form of a multi-center open-label prospective observational controlled pilot study. 15 patients under low dose methotrexate treatment and 15 healthy controls with an indication for yellow fever vaccination will be included. The study duration will be 28 days for each subject and will consist of 6 clinical visits on days 0, 3, 7, 10, 14 and 28.

YF antibodies will be measured on days 0, 7, 10, 14 and 28; viremia will be measured on days 3, 7, 10, 14 and 28.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Not yet recruiting
        • Universitätsklinik für Infektiologie Inselspital
        • Contact:
        • Contact:
      • Geneva, Switzerland, 1211
        • Not yet recruiting
        • Médecine Tropicale et Humanitaire Hôpitaux Universitaires de Genève
        • Contact:
        • Contact:
      • Lausanne, Switzerland, 1011
        • Not yet recruiting
        • PMU | Policlinique médicale universitaire CHUV | Service des maladies infectieuses, Département de médecine
        • Contact:
      • Zurich, Switzerland, 8001
        • Recruiting
        • University of Zurich, Epidemiology, Biostatistics and Prevention Institute
        • Contact:
        • Contact:
    • Aargau
      • Aarau, Aargau, Switzerland, 5001
        • Recruiting
        • Kantonsspital Aarau
        • Contact:
        • Contact:
    • Basel Stadt
      • Basel, Basel Stadt, Switzerland, 4051
        • Recruiting
        • Swiss Tropical and Public Health Institute
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Healthy travelers who have an indication for yellow fever vaccination
Biological: Yellow Fever Vaccination
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative viremia in blood in travelers under low dose methotrexate (≤20mg/week) and healthy travelers
Time Frame: days 3, 7, 10 and 14 and 28
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
Time Frame: days 0, 7, 10, 14 and 28
Serum samples will be collected for measurement of neutralizing antibodies
days 0, 7, 10, 14 and 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of the percentage of travelers with an antibody level of >0.7 LNI (>0.5 IU/ml) in both groups
Time Frame: days 0, 7, 10, 14, 28
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
Time Frame: Throughout day 28 after vaccination
Local and systemic vaccine reactions will be collected in a diray card filled out by the participant
Throughout day 28 after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

University Hospital, Geneva
University Hospital Inselspital, Berne
Centre Hospitalier Universitaire Vaudois
Kantonsspital Aarau
Swiss Tropical & Public Health Institute

Investigators

  • Principal Investigator: Christoph Hatz, Prof MD, University of Zurich, Epidemiolgy, Biostatistics and Prevention Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Estimate)

March 9, 2015

Last Update Submitted That Met QC Criteria

March 3, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS_2014_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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