NCT07536048进行中（未招募）不适用
A Multi-center, Prospective, Longitudinal Cohort Study to Collect Immunological and Clinical Data on Epstein-Barr Virus (EBV) Reactivation in EBV Seropositive Male and Female Adults Aged 18 to 29 Years
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of participants with EBV DNA in blood and saliva at each study visit
研究概览
简要总结
This multi-center, prospective, longitudinal cohort study is designed to gather immunological and clinical data on EBV reactivation in EBV seropositive adults aged 18 to 29 years.
This study will follow a cohort of approximately 100 EBV seropositive adults 18 to 29 years of age in Australia over a 6 or 12-month period.
Participants will not receive any study intervention (eg, study treatments, vaccines).
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 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 29 years on the day of inclusion
- •Participants who are healthy as determined by medical evaluation including medical history and physical examination
- •Participants who are EBV seropositive based on serology testing
排除标准
- •Any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives, including planning to leave the area of the study before the end of study period
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Healthy participants who are EBV seropositive
干预措施: Investigational Procedure (Procedure)
结局指标
主要结局
Number of participants with EBV DNA in blood and saliva at each study visit
时间窗: 6 or 12 months
Serology testing indicative of EBV reactivation, measured by anti-VCA IgG/IgM, anti-EBNA-1 IgG and anti-EA IgG at each study visit
时间窗: 6 or 12 months
次要结局
- Levels of IgG antibodies binding to EBV antigens, measured at selected time points in a subset of participants(6 or 12 months)
- Levels of EBV nAbs in serum measured at selected timepoints in a subset of participants(6 or 12 months)
- Immunogenicity assessments at baseline to identify antibody signatures that may correlate with the occurrence of EBV reactivations during study period. Neutralizing and IgG binding assays will be performed in a subset of participants(6 or 12 months)
研究者
研究点 (2)
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