Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 2,300
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events 60 days after vaccination
研究概览
简要总结
On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19).Due to the decline of immunity and cardiopulmonary function in patients with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, cancer diseases, etc.), COVID-19 's severe illness and mortality mainly increase in these special population. Vaccination of COVID-19 vaccine can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality.To evaluate the safety and effectiveness of the population vaccinated with COVID-19 vaccine, and to play a scientific and theoretical supporting role in guiding COVID-19 vaccination scientifically, reasonably and effectively, so this study was carried out.
详细描述
Due to the decline of immunity and cardiopulmonary function in patients with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, cancer diseases, etc.), COVID-19 's severe illness and mortality mainly increase in these special population. At present, there is no evidence that these special population have been vaccinated against COVID-19, but CDC vaccination and the guidelines and consensus of various professional societies hold that: (1) the people with underlying diseases have low immunity and are easy to develop into severe patients with high mortality; (2) although there is no direct evidence of evidence-based medicine, it is best to be vaccinated with COVID-19 vaccine in the absence of disease progression activities to reduce high risk. To evaluate the safety and effectiveness of the population vaccinated with COVID-19 vaccine, and to play a scientific and theoretical supporting role in guiding COVID-19 vaccination scientifically, reasonably and effectively, so this study was carried out.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The selection criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination.
排除标准
- •The exclusion criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination.
结局指标
主要结局
Number of participants with adverse events 60 days after vaccination
时间窗: 60 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc.
Evaluate the safety of the vaccine by observing the occurrence of adverse events(such as fever, dizziness, nausea, headache，fatigue, myalgia, etc) and recording the number of subjects with adverse events.
Number of participants with adverse events 180 days after vaccination
时间窗: 180 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc.
Evaluate the safety of the vaccine by observing the occurrence of adverse events(such as fever, dizziness, nausea, headache，fatigue, myalgia, etc) and recording the number of subjects with adverse events.
Titer and duration of COVID-19 antibody production 15 days after vaccination
时间窗: 15 days:Detect the titer and duration of COVID-19 antibodies in the body.
The titer and duration of COVID-19 antibody were produced at 15 days, 30 days, 90 days, 180 days after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with basic disease.
Titer and duration of COVID-19 antibody production 30 days after vaccination
时间窗: 30 days:Detect the titer and duration of COVID-19 antibodies in the body.
The titer and duration of COVID-19 antibody were produced at 15 days, 30 days, 90 days, 180 days after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with basic disease.
Number of participants with adverse events 30 days after vaccination
时间窗: 30 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc.
Evaluate the safety of the vaccine by observing the occurrence of adverse events(such as fever, dizziness, nausea, headache，fatigue, myalgia, etc) and recording the number of subjects with adverse events.
Number of participants with adverse events 90 days after vaccination
时间窗: 90 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc.
Evaluate the safety of the vaccine by observing the occurrence of adverse events(such as fever, dizziness, nausea, headache，fatigue, myalgia, etc) and recording the number of subjects with adverse events.
Titer and duration of COVID-19 antibody production 60 days after vaccination
时间窗: 60 days:Detect the titer and duration of COVID-19 antibodies in the body.
The titer and duration of COVID-19 antibody were produced at 15 days, 30 days, 90 days, 180 days after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with basic disease.
Number of participants with adverse events 15 days after vaccination
时间窗: 15 days：Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc.
Evaluate the safety of the vaccine by observing the occurrence of adverse events(such as fever, dizziness, nausea, headache，fatigue, myalgia, etc) and recording the number of subjects with adverse events.
Titer and duration of COVID-19 antibody production 90 days after vaccination
时间窗: 90 days:Detect the titer and duration of COVID-19 antibodies in the body.
The titer and duration of COVID-19 antibody were produced at 15 days, 30 days, 90 days, 180 days after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with basic disease.
Titer and duration of COVID-19 antibody production180 days after vaccination
时间窗: 180 days:Detect the titer and duration of COVID-19 antibodies in the body.
The titer and duration of COVID-19 antibody were produced at 15 days, 30 days, 90 days, 180 days after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with basic disease.
次要结局
- Study on the immune mechanism related to the production of neutralizing antibodies 30 days after vaccination(30 days：Detect the levels of B cells and related subgroups, Treg and CTL)
- Study on the immune mechanism related to the production of neutralizing antibodies 90 days after vaccination(90 days：Detect the levels of B cells and related subgroups, Treg and CTL)
- Study on the immune mechanism related to the production of neutralizing antibodies 180 days after vaccination(180 days：Detect the levels of B cells and related subgroups, Treg and CTL)
- Study on the immune mechanism related to the production of neutralizing antibodies 60 days after vaccination(60 days：Detect the levels of B cells and related subgroups, Treg and CTL)
- Study on the immune mechanism related to the production of neutralizing antibodies 15 days after vaccination(15 days:Detect the levels of B cells and related subgroups, Treg and CTL)
研究者
Hong Ren
Dr/ Prof.
The Second Affiliated Hospital of Chongqing Medical University