Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People With Human Immunodeficiency Virus Infected
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Neutralizing antibody level
研究概览
简要总结
Evaluation of immunogenicity and safety of the subjects infected with HIV to receive the schedule of two doses inactivated COVID-19 vaccine with the interval of 21 days .
详细描述
The subjects infected with HIV were recruited to receive the schedule of two doses inactivated COVID-19 vaccine with the interval of 21 days .
Blood samples will be collected 2 times: before the 1st dose of vaccinatioin and 28 days after the 2nd dose of vaccination.
Any local or systemic adverse events that occurred within 21 days after vaccination will be recorded.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Neutralizing antibody level
时间窗: 28 days after the 2th dose(Day 49)
Neutralizing antibody GMT against coronavirus after the 2th dose
Seroconversion rate
时间窗: 28 days after the 2th dose (Day 49)
The rate of seroconversion against coronavirus
Baseline neutralizing antibody level
时间窗: Before vaccination (Day 0)
Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination
次要结局
- Baseline T cell count(before vaccination (Day 0))
- Adverse events rate(0-21days following vaccinations)
- Serious adverse event rate(0-6 months)
- T cell count(28 days after the 2th dose (Day 49))
- HIV viral load(28 days after the 2th dose (Day 49))
- Baseline HIV viral load(before vaccination (Day 0))