Profiling Antibody Status and Vaccine Effectiveness in Post Vaccination With SARS CoV2 in Ain Shams University
试验速览
- 阶段
- 2 期
- 入组人数
- 4,000
- 试验地点
- 2
- 主要终点
- Short-term effectiveness
研究概览
简要总结
This is a prospective intervention study to assess the effectiveness of both the live attenuated and messenger RNA vaccines against SARS-CoV-2 infection
详细描述
This is a prospective intervention study to assess the short-term effectiveness of the first dose of both the live attenuated and messenger RNA vaccines against SARS-CoV-2 infection by monitoring the antibodies (IgG, IgM and level of neutralizing antibodies) in sera of post-vaccinated persons.
The study also will monitor the incidence of SARS-CoV-2 infection among vaccinees just before the first dose administration, 3 weeks after immunization, at the administration of the second dose, 14 days following the second dose and after 3 and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Age > 18 years old
- •Candidate for receiving vaccination according to health care authorties prioritaizaton
排除标准
- •SARS-CoV-2 recovered cases <3 months
- •Individuals who are currently infected with Sars-COV-2 and/or with respiratory symptoms with fever.
结局指标
主要结局
Short-term effectiveness
时间窗: 21 days of the first dose of vaccine
Assess the short-term effectiveness of the first dose of both the live attenuated and messenger RNA vaccines against SARS-CoV-2 infection by monitoring the antibodies (IgG, IgM and level of neutralizing antibodies) in sera of postvaccinated persons three weeks after first dose
次要结局
未报告次要终点
研究者
Samia Girgis
Professor of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt
Ain Shams University