NCT04528407已完成不适用
Follow-up Study for Patients Having Received FluBHPVE6E7 in Clinical Studies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events (type, frequency, severity).
研究概览
简要总结
This is a follow-up study for patients treated with FluBHPVE6E7 in previous interventional studies.
详细描述
BS-FU01 is a follow-up study for patients treated with FluBHPVE6E7 in previous phase 1 and 2 interventional studies. The aim of the follow-up study is to assess the safety and immunogenicity of FluBHPVE6E7, changes in the HPV infection status, cervical cytology, and biodistribution after treatment with FluBHPVE6E7 in previous studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient who enrolled in previous phase 1 or 2 clinical studies of FluBHPVE6E7
- •Negative pregnancy test at baseline
- •Written informed consent
排除标准
- •Pregnancy, breastfeeding
结局指标
主要结局
Number of participants with adverse events (type, frequency, severity).
时间窗: 1 year
To assess the safety and tolerability of FluBHPVE6E7 by monitoring the type, frequency, and severity of AEs
次要结局
- Cervical cytology(1 year)
- Biodistribution: Detection of FluBHPVE6E7 in blood samples(1 year)
- Induction of HPV-specific T-cell response following FluBHPVE6E7 administration(1 year)
- Induction of HPV-specific CD4+ and CD8+ T-cells following FluBHPVE6E7 administration(1 year)
- Local HPV clearance(1 year)
- Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration(1 year)
- Biodistribution: Detection of FluBHPVE6E7 in nasal secretions(1 year)
研究者
研究点 (1)
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