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航空地勤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:

ChiCTR2100041705 

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:

航空地勤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:

A randomized, controlled trial for the safety and immunogenicity of novel coronavirus pneumonia (COVID-19) inactivated vaccine in airline ground staff 

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 Provincial 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:

+86 15235176807 

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 Provincial 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, Taiyuan, Shanxi, China

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 old; 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. Subjects with history of allergy, convulsion, epilepsy, encephalopathy and psychosis or family history; 2. Patients who are allergic to any component of the vaccine, and have a 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. Patients with severe liver and kidney diseases, respiratory diseases, cardiovascular diseases, malignant tumors; diabetic complications beyond the control of drugs; acute attack of various acute or chronic diseases; 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:

From2021-01-02To 2021-01-10 

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:

加强免疫后血清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:

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:

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:

主要指标 

Outcome:

Serious adverse events (SAE) during the entire study period (6 months after the full 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:

主要指标 

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:

Primary 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):

Data supporting the findings of this study can be obtained from the corresponding authors on 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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