A Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of VN-0200 After Intramuscular Injections in Japanese Healthy Adults and Elderly Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting Treatment-emergent Adverse Events
研究概览
简要总结
This study will assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injections in Japanese healthy adults and elderly subjects.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged ≥20 and ≤50 years (Step 1) or healthy elderly aged ≥65 and ≤80 years (at the time of informed consent)
- •Body mass index (BMI) is ≥18.0 and <30.0 kg/m^2 (at screening)
排除标准
- •Participants with a history of anaphylaxis or severe allergies due to food, medicine, insect bites, cosmetics, or vaccination
- •Having alcohol or drug dependence, etc.
研究组 & 干预措施
Step 1: Placebo
Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo.
干预措施: Placebo (Biological)
Step 2: Placebo
Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo.
干预措施: Placebo (Biological)
Step 2: VN-0200 low dose
Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.
干预措施: VN-0200 (Biological)
Step 1: VN-0200 low dose
Healthy adults subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.
干预措施: VN-0200 (Biological)
Step 2: VN-0200 high dose
Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
干预措施: VN-0200 (Biological)
Step 2: VN-0200 dose medium dose
Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.
干预措施: VN-0200 (Biological)
Step 1: VN-0200 high dose
Healthy adults subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
干预措施: VN-0200 (Biological)
Step 1: VN-0200 medium dose
Healthy adults subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.
干预措施: VN-0200 (Biological)
结局指标
主要结局
Number of Participants Reporting Treatment-emergent Adverse Events
时间窗: From first administration through 28 days post second administration
Number of Participants Reporting Local and Systemic Adverse Events
时间窗: From first administration up to 14 days after second administration
Number of Participants Reporting Serious Adverse Events
时间窗: From date of informed consent up to approximately 3 months
次要结局
- Geometric Mean Fold Rise (GMFR) of Anti-RSV Specific Neutralizing Activity(Day 29 and Day 57 post-dose and at the time of discontinuation (whichever occurs first), up to approximately 2 months)
- Geometric Mean Titer (GMT) of Anti-VAGA-9001a IgG(Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months)
- Geometric Mean Titer (GMT) of Anti-RSV IgG(Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months)
- Number of IFN-γ spot-forming cells in PBMC Detected by ELISPOT(Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months)