Yellow Fever Vaccination Under Low Dose Methotrexate Therapy

Dermatologic Disorders Clinical Trial

— MTX_YF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02383680
• Other study ID #: CS_2014_01
• Status: Recruiting
• Phase: N/A
• First received: March 3, 2015
• Last updated: March 3, 2015
• Start date: December 2014
• Est. completion date: June 2016

Study information

• Verified date: March 2015
• Source: University of Zurich
• Contact: Silja Bühler, MD MSc
• Phone: +41 44634
• Email: silja.buehler[@]ifspm.uzh.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dermatologic Disorders
• Rheumatic
• Skin Diseases
• Yellow Fever

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau	Aargau
Switzerland	Swiss Tropical and Public Health Institute	Basel	Basel Stadt
Switzerland	Universitätsklinik für Infektiologie Inselspital	Bern
Switzerland	Médecine Tropicale et Humanitaire Hôpitaux Universitaires de Genève	Geneva
Switzerland	PMU | Policlinique médicale universitaire CHUV | Service des maladies infectieuses, Département de médecine	Lausanne
Switzerland	University of Zurich, Epidemiology, Biostatistics and Prevention Institute	Zurich

Sponsors (6)

Lead Sponsor	Collaborator
University of Zurich	Centre Hospitalier Universitaire Vaudois, Kantonsspital Aarau, Swiss Tropical & Public Health Institute, University Hospital Inselspital, Berne, University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	Throughout day 28 after vaccination	No