Yellow Fever Vaccination Under Low Dose Methotrexate Therapy - a Multi-Center Prospective Observational Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Quantitative viremia in blood in travelers under low dose methotrexate (≤20mg/week) and healthy travelers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Quantitative viremia in blood in travelers under low dose methotrexate (≤20mg/week) and healthy travelers
时间窗: 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
时间窗: days 0, 7, 10, 14 and 28
Serum samples will be collected for measurement of neutralizing antibodies
次要结局
- 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)