RheumaticMTX_YFNCT02383680
Yellow Fever Vaccination Under Low Dose Methotrexate Therapy
An observational study of Rheumatic and Dermatologic Disorders, run by University of Zurich at 6 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic, Dermatologic Disorders
- What is being tested?
- Yellow Fever Vaccination
- Type of treatment
- Vaccines
- How many people
- 30 participants
- Where
- 6 sitesSwitzerland
- Study dates
- Dec 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Switzerland6 sites, 6 recruiting
- Recruiting
Kantonsspital Aarau
Aarau, Canton of Aargau, 5001
Christoph Fux, PD MD, +41 62 838 68 20, christoph.fux@ksa.ch
Constanze Spelters, Study Nurse, +41 62 838 68 20, constanze.spelters@ksa.ch
- Recruiting
Swiss Tropical and Public Health Institute
Basel, Canton of Basel-City, 4051
Kerstin Kling, MD, +41 61284 ext. 8119, kerstin.kling@unibas.ch
Christoph Hatz, Prof MD, + 41 61284 ext. 8255, christoph.hatz@unibas.ch
- Not yet recruiting
Universitätsklinik für Infektiologie Inselspital
Bern, Canton of Bern, 3010
Hansjakob Furrer, Prof MD, +41 31 632 27 45, Hansjakob.Furrer@insel.ch
Cornelia Staehelin, MD, +41 31 632 27 45, cornelia.staehelin@insel.ch
- Not yet recruiting
Médecine Tropicale et Humanitaire Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, 1211
Gilles Eperon, MD, +41 (0)22 372 96 15, Gilles.Eperon@hcuge.ch
Francois Chappuis, Prof MD, +41 (0)22 372 96 15, francois.chappuis@hcuge.ch
- Not yet recruiting
PMU | Policlinique médicale universitaire CHUV | Service des maladies infectieuses, Département de médecine
Lausanne, 1011
Blaise Genton, Prof MD, +41 21 314 67 68, Blaise.Genton@chuv.ch
- Recruiting
University of Zurich, Epidemiology, Biostatistics and Prevention Institute
Zurich, Canton of Zurich, 8001
Silja Bühler, MD MSc, +41 44634 ext. 4631, silja.buehler@ifspm.uzh.ch
Sabine Schmid, MD, +41 44634 ext. 4608, sabine.schmid@ifspm.uzh.ch
About this study
Official title: 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.
Read the 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.
- Conditions
- Rheumatic, Dermatologic Disorders
- Being tested
- Yellow Fever Vaccination
- Keywords
- Methotrexate therapy
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yellow Fever VaccinationBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Yellow Fever Vaccination | |
| Healthy controls | Healthy travelers who have an indication for yellow fever vaccination Receives: Biological: Yellow Fever Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative viremia in blood in travelers under low dose methotrexate (≤20mg/week) and healthy travelers
Serum samples will be collected for PCR
Measured: 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
Measured: 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
Measured: 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
Local and systemic vaccine reactions will be collected in a diray card filled out by the participant
Measured: Throughout day 28 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionJan 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RheumaticStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute, Kantonsspital Aarau, Insel Gruppe AG, University Hospital Bern, University Hospital, Geneva, Centre Hospitalier Universitaire Vaudois
- Responsible party
- Sponsor
- Investigators
- Christoph Hatz, Prof MD, Principal investigator, University of Zurich, Epidemiolgy, Biostatistics and Prevention Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383680
- Sponsor's protocol ID
- CS_2014_01
- Acronym
- MTX_YF
- Status last verified
- Mar 2015
- First submitted
- 3 Mar 2015
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yellow Fever Vaccination Under Low Dose Methotrexate Therapy - a Multi-Center Prospective Observational Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02383680
- Acronym / sponsor ID
- MTX_YF / CS_2014_01
- Conditions
- Rheumatic, Dermatologic Disorders
- Keywords
- Methotrexate therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute, Kantonsspital Aarau, Insel Gruppe AG, University Hospital Bern, University Hospital, Geneva, Centre Hospitalier Universitaire Vaudois
- Study start
- Dec 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients under low dose methotrexate therapy | – | Biological: Yellow Fever VaccinationPatients with various underlying conditions (e.g. rheumatic diseases, dermatologic diseases) who have an indication for yellow fever vaccination |
| Healthy controls | – | Biological: Yellow Fever VaccinationHealthy travelers who have an indication for yellow fever vaccination |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yellow Fever VaccinationThe 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. | Biological | Healthy controls, Patients under low dose methotrexate therapy |
Primary outcome
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
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
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Hatz, Prof MD principal investigator
University of Zurich, Epidemiolgy, Biostatistics and Prevention Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic and Dermatologic Disorders, run by University of Zurich at 6 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silja Bühler, MD MSc (+41 44634 ext. 4631, silja.buehler@ifspm.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.