A Randomized, Single-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Occurrence of serious adverse events
研究概览
简要总结
A total of 63 subjects will be recruited into three groups (18 subjects per group will receive MVA BN RSV vaccine and three subjects per group will receive placebo). Liquid frozen suspension of MVA BN RSV.
Each subject will receive two vaccinations with either MVA-BN RSV vaccine 1 x 108 TCID50 per 0.5 ml, 1 x 107 TCID50 per 0.5 ml or with placebo.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •signed and dated an informed consent form
- •Body mass index ≥ 18.5 and <
- •Women of childbearing potential (WOCBP) must have used an acceptable method of contraception
排除标准
- •Pregnant or breast-feeding women.
- •Uncontrolled serious infection, i.e. not responding to antimicrobial therapy.
- •History of any serious medical condition.
- •History of or active autoimmune disease.
- •Known or suspected impairment of immunologic functions.
结局指标
主要结局
Occurrence of serious adverse events
时间窗: Screening up to week 34 after first vaccination
Occurrence, relationship to the trial vaccine and intensity of any serious adverse event (SAE).
Occurrence of grade 3 adverse events
时间窗: Screening up to week 8 after first vaccination
Occurrence of any grade 3 or higher adverse events possibly, probably or definitely related to the trial vaccine within four weeks after each vaccination.
Solicited local adverse events
时间窗: day of vaccination and the following seven days
Occurrence, intensity and duration of solicited local adverse events after each vaccination Occurrence, intensity and duration of solicited local adverse events after each vaccination Occurrence, intensity and duration of solicited local adverse events after each vaccination
Solicited general adverse events
时间窗: day of vaccination and the following seven days
Occurrence, relationship to the trial vaccine, intensity and duration of solicited general adverse events
Unsolicited non-serious adverse events
时间窗: within four weeks after each vaccination
Occurrence, relationship to the trial vaccine and intensity of unsolicited non-serious adverse events
次要结局
- Vaccinica-specific humoral immune response(humoral immune response is measured up to week 34)
- Vaccinia-specific cellular immune responses.(cellular immune response measured up to week 4 after 2nd vaccination)
- RSV-specific humoral immune response(humoral immune response is measured up to week 34)