ISRCTN17974967已完成Unknown
Establishment and analysis of a yellow fever vaccination cohort for the identification of individual prognostic factors in vaccinations and acute viral infections
udwig Maximilian University of Munich0 个研究点目标入组 250 人开始时间: 2023年8月26日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 250
研究概览
简要总结
2023 Preprint results in https://www.biorxiv.org/content/10.1101/2023.05.07.539594v1.full.pdf (added 24/07/2023)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Male or female individuals between the ages of 18 and 55 years old
- •2. Healthy with no acute infections or chronic diseases
- •3. Women must have a negative pregnancy test
- •4. Willingness to provide written informed consent after being thoroughly informed of the risks and benefits of the study
- •5. Availability for all study time points (i.e., able to attend all study visits)
排除标准
- •1. Pregnant or lactating women
- •2. Previously received a yellow fever vaccination
- •3. Pre-existing flaviviral diseases such as dengue fever or West e virus infection
- •4. Known allergies to egg or egg components or aminoglycosides
- •5. A temperature greater than 38°C on the day of study entry or an acute illness (with or without fever) on the same day
- •6. Receipt of any other vaccination less than 30 days before the study
- •7. A history of autoimmune diseases or immunosuppression
- •8. Known anaphylactic or allergic reactions
- •9. Using unregistered drugs or drugs in clinical trials
- •10. Clinically significant mental illness
- •11. Receipt of immunoglobulins or blood products within three months of the study or are planning to do so during the study
- •12. Injection drug users
- •13. Ongoing tumor diseases
- •14. Past or current manifestations of haematological, renal, hepatic, pulmonary, CNS, cardiovascular, or gastrointestinal diseases
- •15. Anyone deemed by the investigator to not be compliant with the study objectives and protocol
- •16. A foreseeable absence from the study center during the study period, such as due to a planned vacation
研究者
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