A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate A Range of Dose Levels of a Heterologous Prime-Boost Regimen of Ad26.ZEBOV and MVA-BN®-Filo in Healthy Adult Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 525
- 主要终点
- Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA)
研究概览
简要总结
The purpose of this study is to demonstrate the non-inferiority of a heterologous prime-boost regimen using Ad26.ZEBOV as prime and MVA-BN-Filo as boost administered at different doses at a 56-day interval versus the same regimen with the recently released batches of Ad26.ZEBOV and MVA-BN-Filo in terms of humoral immune response against the Ebola virus (EBOV) GP (glycoprotein) as measured by enzyme-linked immunosorbent assay (ELISA) at 21 days post boost.
详细描述
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate safety and immunogenicity of Ad26.ZEBOV and MVA-BN-Filo at different dose levels, administered to healthy adults participants. The study consists of a Screening period of up to 6 weeks, vaccinations on Day 1 and Day 57, and a post-vaccination phase until the 6 months post-boost visit (Day 237). The participants will be randomized at baseline (on Day 1) in a 2:2:2:1 ratio to Groups 1, 2, 3 and 4. Safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（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
Group 1
Ad26.ZEBOV 5*10^10 viral particles (vp) single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] single dose IM injection on Day 57
干预措施: Ad26.ZEBOV 5*10^10 viral particles (vp) (Biological)
Group 1
Ad26.ZEBOV 5*10^10 viral particles (vp) single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] single dose IM injection on Day 57
干预措施: MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] (Biological)
Group 2
Ad26.ZEBOV 2*10^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5*10^7 Inf. U single dose IM injection on Day 57
干预措施: Ad26.ZEBOV 2*10^10 (vp) (Biological)
Group 2
Ad26.ZEBOV 2*10^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5*10^7 Inf. U single dose IM injection on Day 57
干预措施: MVA-BN-Filo 5*10^7 Inf. U. (Biological)
Group 3
Ad26.ZEBOV 0.8*10^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5*10^7 Inf. U. single dose IM injection on Day 57
干预措施: Ad26.ZEBOV 0.8*10^10 (vp) (Biological)
Group 3
Ad26.ZEBOV 0.8*10^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5*10^7 Inf. U. single dose IM injection on Day 57
干预措施: MVA-BN-Filo 5*10^7 Inf. U. (Biological)
Group 4
Participants will receive intramuscular (IM) injection of Placebo (0.9% saline) once on Day 1 and Day 57
干预措施: Placebo (Biological)
结局指标
主要结局
Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA)
时间窗: At 21 days post boost vaccination
The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody
次要结局
- Number of Participants with Solicited Local and Systemic Adverse Events (AEs)(Up to 7 days after each vaccination)
- Number of Participants with Serious Adverse Events (SAEs)(Continuous throughout the duration of study (Up to Day 237))
- Number of Participants with Adverse Events (AEs)(Up to 42 days post boost vaccination)
- Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA)(At Days 1, 29, 57 post prime dose and at days 42, and 180 post boost vaccination)