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安全保障人员接种新型冠状病毒肺炎(COVID-19)灭活疫苗安全性和免疫原性的随机对照研究
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注册号:

Registration number:

ChiCTR2100041706 

最近更新日期:

Date of Last Refreshed on:

2021-03-21 

注册时间:

Date of Registration:

2021-01-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

安全保障人员接种新型冠状病毒肺炎(COVID-19)灭活疫苗安全性和免疫原性的随机对照研究 

Public title:

Safety and immunogenicity of New Coronavirus vaccine (COVID-19) inactivated by safety personnel: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

SARS-CoV-2灭活疫苗安全性和免疫原性的随机对照多中心研究 

Scientific title:

A randomized, controlled, multicenter study on the safety and immunogenicity of SARS-CoV-2 inactivated vaccine 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

冯永亮 

研究负责人:

陈靖 

Applicant:

Yongliang Feng 

Study leader:

Jing Chen 

申请注册联系人电话:

Applicant telephone:

+86 351-4135362 

研究负责人电话:

Study leader's telephone:

+86 351-7553016 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

yongliang.feng@sxmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

524210737@qq.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

山西省太原市新建南路56号 

研究负责人通讯地址:

山西省太原市小南关街8号 

Applicant address:

56 Xinjian Road South, Taiyuan, Shanxi, China 

Study leader's address:

8 Xiaonanguan Street, Taiyuan, Shanxi, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

山西医科大学 

Applicant's institution:

Shanxi Medical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

SXCDCIRBPJ2020056001 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

山西疾病预防控制中心伦理审查委员会 

Name of the ethic committee:

Ethics Committee of Shanxi Center for Disease Control and Prevention 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-09-21 

伦理委员会联系人:

张夏虹 

Contact Name of the ethic committee:

Xiahong Zhang 

伦理委员会联系地址:

山西省太原市小南关街8号 

Contact Address of the ethic committee:

8 Xiaonanguan Street, Taiyuan, Shanxi, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

山西省疾病预防控制中心 

Primary sponsor:

Shanxi Center for Disease Control and Prevention 

研究实施负责(组长)单位地址:

山西省太原市小南关街8号 

Primary sponsor's address:

8 Xiaonanguan Street, Taiyuan, Shanxi, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山西

市(区县):

太原

Country:

China

Province:

Shanxi

City:

Taiyuan

单位(医院):

山西省疾病预防控制中心

具体地址:

小南关街8号

Institution
hospital:

Shanxi Provincial Center for Disease Control and Prevention

Address:

8 Xiaonanguan Street

经费或物资来源:

重大传染性疾病防控与诊治山西省重点实验室资助;山西省“新冠肺炎”财政资助专项 

Source(s) of funding:

Project funded by Shanxi Provincial Key Laboratory for major infectious disease response; COVID-19 project funded by Shanxi Provincial Finance 

研究疾病:

新型冠状病毒肺炎 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

评价SARS-CoV-2灭活疫苗在0、14,0、21,0、28天不同免疫程序下的免疫原性和安全性,并评估疫苗的加强免疫效果。 

Objectives of Study:

To evaluate the immunogenicity and safety of the SARS-CoV-2 inactivated vaccine at the different schedule of day 0,14, day 0, 21, or day 0,28 and to assess the effect of vaccines in enhancing immunity. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.年龄18-59岁; 2.签署知情同意书,自愿参加者; 3.依从性好; 4.受试者与最近1次疫苗接种时间间隔≥14天; 5.在进入这项研究之前,经病史和临床检查且体温≤37.0℃。 

Inclusion criteria

1. Subjects aged 18-59 years; 2. The subjects who signed the informed consent form and participated voluntarily; 3. Subjects with good compliance; 4. Subjects with the interval of more than 14 days from the last vaccination; 5. Before entering this study, subjects with history and clinical examination and body temperature <= 37.0 degrees C. 

排除标准:

1.有过敏、惊厥、癫痫、脑病和精神病等病史或家族史者; 2.对疫苗中任一成份过敏者,既往有任何疫苗接种严重过敏史者(如急性过敏反应、荨麻疹、皮肤湿疹、呼吸困难、血管神经性水肿或腹痛); 3.患免疫缺陷症、恶性肿瘤治疗期间、接受免疫抑制剂治疗(口服类固醇激素)或HIV导致的免疫力低下者,或密切接触的家庭成员中有先天性免疫疾病者; 4.入组前1个月内注射非特异免疫球蛋白; 5.严重的肝肾疾病、呼吸系统疾病、心血管疾病,恶性肿瘤;药物不可控制的糖尿病并发症;各种急性疾病或慢性疾病急性发作期;各种感染性、化脓性及过敏性皮肤病; 6.入组前1个月内注射非特异免疫球蛋白; 7.患急性发热性疾病体温>37.0℃者及传染病者; 8.孕期或哺乳期的妇女。 

Exclusion criteria:

1. Patients with history of allergy, convulsion, epilepsy, encephalopathy and psychosis or family history; 2. Those who are allergic to any component of the vaccine, and those who have had any history of severe allergy to the vaccine (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain); 3. Patients with immunodeficiency, cancer treatment, immunosuppressive therapy (oral steroids) or HIV induced hypoimmunity, or close family members with congenital immune diseases; 4. Subjects injected with non-specific immunoglobulin within one month before enrollment; 5. Severe liver and kidney diseases, respiratory system diseases, cardiovascular diseases, malignant tumors; patients with uncontrollable diabetic complications; acute attack of various acute or chronic diseases; various infectious, suppurative and allergic skin diseases; 6. Subjects injected with non-specific immunoglobulin within one month before enrollment; 7. Subjects with acute febrile diseases and infectious diseases whose body temperature is more than 37.0 degrees C; 8. Pregnant or lactating women. 

研究实施时间:

Study execute time:

From2020-09-28To 2021-03-27 

征募观察对象时间:

Recruiting time:

From2021-01-05To 2021-01-11 

干预措施:

Interventions:

组别:

0、14紧急接种组

样本量:

120

Group:

0,14 emergency vaccination group

Sample size:

干预措施:

在0、14天接种两针疫苗

干预措施代码:

Intervention:

two doses of vaccine at the schedule of day 0,14

Intervention code:

组别:

0、21紧急接种组

样本量:

120

Group:

0, 21 emergency vaccination group

Sample size:

干预措施:

在0、21天接种两针疫苗

干预措施代码:

Intervention:

two doses of vaccine at the schedule of day 0, 21

Intervention code:

组别:

0、28紧急接种组

样本量:

120

Group:

0,28 emergency vaccination group

Sample size:

干预措施:

在0、28天接种两针疫苗

干预措施代码:

Intervention:

two doses of vaccine at the schedule of day 0, 28

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山西 

市(区县):

太原 

Country:

China 

Province:

Shanxi 

City:

Taiyuan 

单位(医院):

山西航空产业集团有限公司 

单位级别:

N/A 

Institution
hospital:

Outpatient Department of Shanxi Aviation Industry Group Co. LTD  

Level of the institution:

N/A 

测量指标:

Outcomes:

指标中文名:

两剂疫苗接种后28天血清SARS-CoV-2中和抗体、IgG抗体和IgM抗体

指标类型:

主要指标 

Outcome:

Serum neutralizing antibodies, IgG antibodies, and IgM antibodies of SARS-CoV-2 28 days after the last dose of vaccination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

两剂疫苗接种后28天全血中SARS-CoV-2特异性免疫细胞水平

指标类型:

次要指标 

Outcome:

The specific immune cell level of SARS-CoV-2 in whole blood 28 days after the last dose of vaccination

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

加强疫苗免疫后血清SARS-CoV-2中和抗体、IgG抗体和IgM抗体的检测

指标类型:

次要指标 

Outcome:

Serum neutralizing antibodies, IgG antibodies, and IgM antibodies of SARS-CoV-2 after enhancing immunity of vaccination

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

每针疫苗接种后7天和6个月内的局部和全身不良反应/事件

指标类型:

次要指标 

Outcome:

Local and systemic adverse reactions/events within 7 days and 6 months after each dose

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全程接种疫苗后6个月的严重不良事件(SAE)

指标类型:

次要指标 

Outcome:

Serious adverse events (SAE) 6 months after the full vaccination

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

两剂疫苗接种后3、6、12个月血清SARS-CoV-2中和抗体、IgG抗体和IgM抗体

指标类型:

次要指标 

Outcome:

Serum neutralizing antibodies, IgG antibodies, and IgM antibodies of SARS-CoV-2 at months 3, 6, and 12 after the last dose of vaccination

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

鼻咽拭子

组织:

Sample Name:

Nasopharyngeal swab

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 59 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

应用SAS 9.4软件,采用区组随机方法进行随机分组。

Randomization Procedure (please state who generates the random number sequence and by what method):

Randomize according to the block random method with SAS 9.4 software.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

支持这项研究结果的数据可以在合理要求下从通讯作者那里获得。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The data that support the findings of this study are available from the corresponding author upon reasonable request.

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

CRF, EpiData3.1, SAS9.4系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

CRF, EpiData3.1, SAS9.4 system

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2021-01-01
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