Evaluation of Immunogenicity and Safety of COVID-19 Vaccine (Produced in Wuhan) in Patients With Hypertension and/or Diabetes
2021年10月16日 更新者：China National Biotec Group Company Limited
A Post-marketing Clinical Study of the Inactivated SARS-CoV-2 Vaccine (Vero Cells) (Produced in Wuhan): Immunogenicity and Safety Assessments in Patients With Hypertension and/or Diabetes
To evaluate the post-marketing immunogenicity and safety of the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (Vero cells) in patients aged 60 years or older with hypertension and/or diabetes, thus to further collect the immunogenicity and safety data of this product in special populations.
研究概览
详细说明
After giving informed consent, patients with hypertension, patients with diabetes, patients with both diseases, and healthy controls, all aged 60 years or older, were given two doses of the inactivated SARS-CoV-2 vaccine (Vero cells).
Venous blood samples were collected before the first dose and on day 28 after the second dose to evaluate the immunogenicity of the vaccine.
Adverse events were actively recorded on a diary card once daily from day 0 to day 7 and once from day 8 to day 21 after the first dose and the second dose.
Within 3 months after immunization with the second dose and collection of diary cards, the subjects were followed up by phone once a month as well as self-report to collect serious adverse events.
研究类型
介入性
注册 (预期的)
1440
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ruizhi ZHANG
- 电话号码：+86-13985441115
- 邮箱：919987774@qq.com
学习地点
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Fujian
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Quanzhou、Fujian、中国
- Nan'an Center for Disease Control and Prevention
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接触：
- Siqun HU
- 电话号码：+86-15880960857
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Guizhou
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Tongren、Guizhou、中国
- Songtao Miao Autonomous County Center for Disease Control and Prevention
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接触：
- Jie TAN
- 电话号码：+86-18311709889
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Hunan
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Zhuzhou、Hunan、中国
- You County Center for Disease Control and Prevention
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接触：
- Zixiong LIU
- 电话号码：+86-13974179882
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- ≥60 years old individuals with full civil capacity.
- Clinically confirmed body temperature of <37.3°C before enrolling in this study.
- Able and willing to participate in the study plan during the entire study and follow-up period.
- Capable of understanding the study procedures, willing to sign the informed consent form, and able to comply with the requirements of the clinical study protocol.
- Inclusion criteria for patients with hypertension and/or diabetes: Hypertension and/or diabetes definitively diagnosed by a community-level or higher medical institution. Patients with hypertension: systolic pressure <160 mmHg and diastolic pressure <100 mmHg on the day of immunization achieved by lifestyle adjustment and/or drug treatment; patients with diabetes: fasting glucose ≤13.9 mmol/L on the day of (or within 3 days before) immunization achieved by lifestyle adjustment and/or drug treatment.
Exclusion Criteria:
- Previously confirmed or asymptomatic COVID-19 patient.
- Has been immunized with a SARS-CoV-2 vaccine.
- Illiterate.
- Known allergy to any ingredient (including excipient) of this product.
- Received non-specific immunoglobulin injection within 1 month before enrollment.
- Received a live attenuated vaccine within 1 month before immunization or other vaccine within 14 days before immunization.
- Previous serious allergy to vaccine (e.g., acute allergic reaction, urticaria, angioedema, and dyspnea).
- Has uncontrolled epilepsy and other progressive neurological disorders; history of Guillain-Barré syndrome.
- Severe respiratory disorders, severe hepatic and renal diseases, malignancies, and various acute diseases or acute onset of chronic diseases.
- Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases.
- Definitively diagnosed with thrombocytopenia or history of other coagulation disorders that may cause subcutaneous injection to be contraindicated.
- Currently experiencing acute complications (ketoacidosis, hyperosmolar state, lactic acidosis, etc.) of diabetes; or within 2 weeks after recovery from these complications.
- Other physical conditions judged by the investigator that render the patient unsuitable for participation in the clinical study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：高血压组
高血压组将招募 330 名患有高血压的受试者（60 岁或以上）。
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2 剂 Covid-19 疫苗
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有源比较器：健康人群
健康人组将招募480名没有高血压或糖尿病病史的受试者（60岁或以上）。
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2 剂 Covid-19 疫苗
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实验性的：Diabetes Mellitus group
Diabetes group will enroll 330 subjects with diabetes (aged 60 years or older).
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2 剂 Covid-19 疫苗
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实验性的：Combined Disease group
Combined Diseases group will enroll 300 subjects with both hypertension and diabetes (aged 60 years or older).
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2 剂 Covid-19 疫苗
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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血清转化率
大体时间：第二剂后最多 28 天
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冠状病毒阳性血清转化率
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第二剂后最多 28 天
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中和抗体水平
大体时间：第二剂后最多 28 天
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冠状病毒中和抗体水平
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第二剂后最多 28 天
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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接种疫苗后的不良事件
大体时间：长达 6 个月
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分析免疫接种后不良事件的发生率，包括主动和主动的
|
长达 6 个月
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2021年10月1日
初级完成 (预期的)
2022年1月1日
研究完成 (预期的)
2022年3月1日
研究注册日期
首次提交
2021年9月28日
首先提交符合 QC 标准的
2021年10月1日
首次发布 (实际的)
2021年10月4日
研究记录更新
最后更新发布 (实际的)
2021年10月25日
上次提交的符合 QC 标准的更新
2021年10月16日
最后验证
2021年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.