Randomised, Double-blind, Placebo-controlled Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV-16 Infected Women With Normal Cytology, CIN1 or CIN2
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events (type, frequency, severity).
研究概览
简要总结
BS-01 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study assessing safety, tolerability and immunogenicity of FluBHPVE6E7, changes in the HPV infection status and cervical cytology, and biodistribution in HPV-16 infected women with normal cytology, CIN1 or CIN2. The safety and immunogenicity of two dose levels, 7.5 log10 and 9.0 log10 fTCID50/dose of FluBHPVE6E7 are assessed after three subcutaneous administrations. In addition the safety of 9.0 log10 fTCID50/dose of FluBHPVE6E7 is assessed after three intradermal or intramuscular administrations.
详细描述
BS-01 is a randomised, placebo-controlled, double- blind phase 1 dose-escalation study in women with normal cytology, CIN1 or CIN2.
The primary objective is to assess the safety and tolerability of FluBHPVE6E7. Secondary objectives are the assessment of the systemic immune responses to immunisations with FluBHPVE6E7, changes in HPV infection status and cervical cytology, and biodistribution.
Study medication is administered three times (Day 0, Week 4, Week 12). Study participants are randomised at a ratio of 3:1 for FluBHPVE6E7 or placebo. The first cohort is treated subcutaneously at dose level 7.5 log10 fTCID50/dose. The second cohort is treated subcutaneously at 9.0 log10 fTCID50/dose.
Interim safety reviews are performed by a Data Monitoring Committee. After completion of the dose-escalation and in order to collect additional safety data on the highest safe and tolerated dose level, additional study participants are enrolled into expansion cohorts treated three times subcutaneously, intradermally or intramuscularly at 9.0 log10 fTCID50/dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of participants with adverse events (type, frequency, severity).
时间窗: 7 days
To assess the safety and tolerability of FluBHPVE6E7 by monitoring the type, frequency, and severity of AEs
次要结局
- Number of participants with adverse events (type, frequency, severity).(16 weeks)
- Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration(16 weeks)
- Induction of HPV-specific CD4+ and CD8+ T-cells following FluBHPVE6E7 administration(16 weeks)
- Cervical cytology(16 weeks)
- Local HPV clearance(16 weeks)
- Induction of HPV-specific T-cell response following FluBHPVE6E7 administration(16 weeks)
- Biodistribution: Detection of FluBHPVE6E7 in nasal secretions(16 weeks)
- Biodistribution: Detection of FluBHPVE6E7 in blood samples(16 weeks)