NL-OMON56630尚未招募不适用
TCR repertoire analysis after Hepatitis A vaccination - TRAI
niversitair Medisch Centrum Utrecht0 个研究点目标入组 145 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 145
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •For the Hepatitis A positive cohort (only in Phase I)
- •To be eligible for inclusion in the Hepatitis A seropositive cohort of this
- •study, a subject must meet all of the following criteria:
- •Participants
- •have recently (< 12 months) been vaccinated with Hepatitis A vaccine
- •are able to follow the protocol of the study during the study period
- •For the Hepatitis A sero-negative cohort (of both Phase I and II)
- •To be eligible for inclusion in the Hepatitis A seronegative cohort, a subject
- •must meet all of the following criteria:
- •Participants are
- •without previous record of vaccination/ infection with Hepatitis A
- •able to follow the protocol of the study during the study period
排除标准
- •Broadly , we want to exclude participants with a CMV infection and participants
- •with diseases or lifestyle that have a negative impact on the immmune system.
- •To insure this we exclude the participants with
- •1. Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV)
- •or hepatitis C virus (HCV);
- •2. Other current serious infections, such as malaria or a sexually transmitted
- •disease (STD);
- •3. Infection with CMV
- •3. Active allergy;
- •4. Asthma, Diabetes, COPD;
- •5. Any previous known hepatic illness
- •6. Autoimmune diseases, such as rheumatoid arthriti
- •7. A body weight less than 50 kg;
- •8. Excessive alcohol consumption (more than 36 drinks per week for men, for
- •women more than 24 drinks per week);
- •9. Medication use, apart from if the medication is known to affect the immune
- •system; and painkillers, if used lessmore than twice per week (paracetamol,
- •ibuprofen, aspirin);
- •10. Drug use;
- •11. Heart problems for which the subject is currently undergoing treatment;
- •12. Kidney complaints for which medication is currently used;
- •13. Shortness of breath or chest pain, at rest or with exertion;
- •14. Cancer or a history of cancer;
- •15. Pregnant and Nursing women
- •16. Blood donors who are not willing to stop donating blood in the duration of
- •this study.
- •17. People with allergic reaction/sensitivity towards neomycin, latex or
- •formaldehyde.
- •18. People with Anemia.
- •The reasoning for this is further elaborated in section 4.3 of C1
- •Onderzoeksprotocol.
研究者
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