Phase 1 Study to Assess the Safety and Exploratory Immunogenicity of PV-001
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Safety assessment
研究概览
简要总结
Study Title:
Evaluation of the Safety and Immunogenicity of a Third Dose of PV-001 in Healthy Women Aged 19-45
Objective:
To assess the safety and antibody response of a third dose of PV-001 in healthy adult female participants.
Key Questions Is PV-001 safe? What adverse events may occur after vaccination? Does PV-001 produce an effective immune response?
Participant Activities :
Three clinic visits for screening and vaccination Blood samples collected on a set schedule Monitoring for side effects after vaccination
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
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 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
PV-001 vaccine
干预措施: PV-001 (Biological)
PEV-001
干预措施: PEV-001 (Biological)
结局指标
主要结局
Safety assessment
时间窗: 180 days after last dose of vaccination
Adverse Events: Immediate adverse reactions occurring within 30 minutes after administration of the investigational product (e.g., syncope, loss of consciousness, anaphylaxis-related events), Expected local and systemic adverse reactions occurring within 7 days following administration of the investigational product, and Unexpected adverse events occurring from the first dose through 180 days after the third dose (Visit 11).
次要结局
- Exploratory immunogenicity assessment(At 4 months after the second dose (Visit 8) and 28 days after the third dose (Visit 10), relative to baseline (Visit 1, prior to the first dose of the investigational product))