Yellow Fever Vaccination Under Low Dose Methotrexate Therapy

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02383680

Acronym

MTX_YF

Enrollment

Registered

2015-03-09

Start date

2014-12-31

Completion date

2016-06-30

Last updated

2015-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatologic Disorders, Rheumatic

Keywords

Methotrexate therapy

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.

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.

Interventions

BIOLOGICALYellow 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	Local and systemic vaccine reactions will be collected in a diray card filled out by the participant

Countries

Switzerland

Contacts

Primary ContactSilja Bühler, MD MSc

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

Backup ContactChristoph Hatz, Prof MD

christoph.hatz@unibas.ch+41 44634

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026