An Open-label, Single Arm Study to Provide Additional Information on Immunogenicity and Safety of Ad26.ZEBOV/MVA-BN-Filo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- The total IgG against EBOV-GP at day 77 post-vaccination with Ad26.ZEBOV (dose 1) at day 0 and MVA-BN®-Filo (dose 2) at day 56.
研究概览
简要总结
An open-label, single arm phase II study of the candidate Ebola Vaccine Ad26.ZEBOV/MVA-BN®-Filo
详细描述
This is an interventional, single arm, open-label, non-randomized, phase II study to accumulate additional data on immunogenicity and safety of Ad26.ZEBOV/MVA-BN®-Filo against Ebola virus disease.
It also has a qualitative component to better understand knowledge about Ebola virus disease and the perception and attitudes towards the vaccine amongst participants (Healthcare and Frontline workers).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Arm
Ad26.ZEBOV/ MVA-BN-Filo Vaccines
干预措施: Ad26.ZEBOV/MVA-BN-Filo (Drug)
结局指标
主要结局
The total IgG against EBOV-GP at day 77 post-vaccination with Ad26.ZEBOV (dose 1) at day 0 and MVA-BN®-Filo (dose 2) at day 56.
时间窗: 21-days post second vaccination
Humoral immune responses as measured by enzyme-linked immunosorbent assay (ELISA) to the Ebola glycoprotein after intramuscular administration of Ad26.ZEBOV/ MVA-BN®-Filo vaccine in all participants on Day 0 and Day 77.
Frequency, incidence and nature of Serious Adverse Events, 6 months following the second vaccination
时间窗: 6 months following second vaccination
The occurrence, incidence and nature of Serious Adverse Events between the time of vaccination with Ad26.ZEBOV and during the ¬ 6 months following vaccination with MVA-BN®-Filo. If a participant does not receive MVA-BN®-Filo for any given reason, the outcome will be the occurrence, incidence and nature of SAE during the 6 months following vaccination with Ad26.ZEBOV
次要结局
- The total IgG against EBOV-GP at 365-days post-vaccination with Ad26.ZEBOV/MVA-BN®-Filo(365-days post-vaccination with Ad26.ZEBOV/MVA-BN®-Filo)
- The total IgG against EBOV-GP at day 56(Day 56 post vaccination with Ad26.ZEBOV)
- The existing knowledge about Ebola disease and transmission, and the perception and attitudes about the vaccine and protection in a subset of participants.(At baseline (Day 0) and after the second Vaccination)