Bioarray for the Serological Assessment of Immunity Against Vaccine-preventable Infections (StikoSero)
Bioarray Compilation for the Serological Assessment of Immunity Against Vaccine-preventable Infections of Available Prophylaxis in Refugees and Immigrants
研究概览
详细说明
The current massive inflow of refugees and migrants poses urgent necessity of i) rapid identification of carriers of communicable diseases and ii) adjustment of protection against vaccine-preventable infections to European standards. While universal vaccination is supposed to ensure the intended degree of protection, targeted vaccination on the basis of previous assessment of the immune status (seropositivity) was repeatedly shown to be a cost-efficient alternative. Currently, the broad use of immune status assessment prior to targeted vaccination is impeded by the necessity to apply separate seropositivity detection assays for each individual condition. This drawback can be overcome by the introduction of a comprehensive diagnostic tool permitting simultaneous assessment of seropositivity for several vaccine-preventable infections.
The objective of the present study consists in compilation of an array of sera from
- subjects with known history of immunization against vaccine-preventable infections for which vaccines are routinely available (measles, mumps, rubella, varicella, tetanus, pertussis, poliomyelitis, diphtheria, meningococcal infection) and
- new migrants/refugees without reliable vaccination records and undefined immune status to be subsequently used for the validation of a multi-pronged diagnostic tool for seropositivity detection
研究类型
注册 (预期的)
联系人和位置
学习地点
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-
Thuringia
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Jena、Thuringia、德国、07747
- 招聘中
- Center for Infectious Diseases and Infection Control, Jena University Hospital
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接触：
- Benjamin Schleenvoigt, M.D.
- 电话号码：+4936419324652
- 邮箱：benjamin.schleenvoigt@med.uni-jena.de
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age above 18 years
- Signed informed consent
Exclusion Criteria:
- Acute infectious condition
- Glucocorticoid medication above 0.3 mg/kg Prednisolone equivalent over the preceding 30 days
- Treatment with recognized T cell immunosuppressant or nucleoside analogues during the preceding 90 days
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Known vaccination history
Single blood sample collection from subjects with verified records of vaccination or recent booster immunization against measles, mumps, rubella, varicella, tetanus, pertussis, poliomyelitis, diphtheria, meningococcal infection
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Collection of single blood sample of 10 ml volume by venepuncture
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|
Migrants
Single blood sample collection from recent migrants to Germany without verified vaccination records
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Collection of single blood sample of 10 ml volume by venepuncture
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Serum sample array compilation
大体时间：1 year
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Collection of individual serum samples from participants with different vaccination history
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1 year
|
合作者和调查者
调查人员
- 首席研究员：Mathias Pletz, M.D.、Center for Infectious Diseases and Infection Control
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.