Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above After a Two-dose Schedule
试验速览
- 阶段
- 3 期
- 入组人数
- 880
- 试验地点
- 1
- 主要终点
- Seroconversion rate of Neutralizing and IgG antibodies against SARS-CoV-2
研究概览
简要总结
To evaluate the immunogenicity and safety of the third dose SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above, who inoculated the third dose after 3, 4, 5, or 6 months since finished two doses schedule of Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2 inactivated vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 是
入选标准
- •Axillary temperature ≤37.0 ℃.
- •aged 18 years and above, after 3, 4, 5, or 6 months since finished two doses schedule of Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2 inactivated vaccine.
- •Proven legal identity, could come each visit.
- •Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form.
排除标准
- •Persons with a clear history of SARS-CoV-2 infection.
- •Using blood products after basic immunization or receiving immunosuppressive therapy.
- •Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 6 months after vaccination.
- •Allergic to the active substance in the vaccine, any inactive substance or substance used in the preparation process (aluminum hydroxide, glycine);
- •History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
- •Diseases beyond drug control, such as high blood pressure, diabetes, asthma.
- •Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
- •Immunization with any vaccine within 14 days.
- •Any other situations judged by investigators as not suitable for participating in this study.
结局指标
主要结局
Seroconversion rate of Neutralizing and IgG antibodies against SARS-CoV-2
时间窗: From 0 days to 6 month after the third dose
Seroconversion rate of neutralizing antibodies and IgG against SARS-CoV-2 in serum for the third dose immunization schedule
Adverse reactions/events rate
时间窗: 28 days after vaccination
Occurence of adverse reactions/events after vaccination
SARS-CoV-2 specific memory B and T cell response
时间窗: From 0 days to 6 month after the third dose
SARS-CoV-2 specific memory B and T cell response for the third dose immunization schedule
次要结局
未报告次要终点
研究者
Jingsi Yang
Senior Technologist
Chinese Academy of Medical Sciences