Today is 2020-08-11

A Phase III clinical trial for inactivated novel coronavirus pneumonia (COVID-19) vaccine (Vero cells)
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注册号:

Registration number:

ChiCTR2000034780 

最近更新日期:

Date of Last Refreshed on:

2020-07-19 

注册时间:

Date of Registration:

2020-07-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型冠状病毒肺炎(COVID-19)灭活疫苗(Vero细胞)Ⅲ期临床试验 

Public title:

A Phase III clinical trial for inactivated novel coronavirus pneumonia (COVID-19) vaccine (Vero cells)  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价新型冠状病毒灭活疫苗(Vero细胞)在18岁及以上健康人群中接种后保护效力和安全性的随机、双盲、安慰剂对照Ⅲ期临床试验 

Scientific title:

Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Safety and Protective Efficacy of Inactivated SARS-CoV-2 Vaccine in Healthy Population Aged 18 Years and above 

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:

陈伟 

研究负责人:

Dr. Nawal Al Kaabi 

Applicant:

Wei Chen 

Study leader:

Dr. Nawal Al Kaabi 

申请注册联系人电话:

Applicant telephone:

+86 027 88862194 

研究负责人电话:

Study leader's telephone:

+97 15 05595521 

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:

564890016@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

nalkaabi@seha.ae 

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:

湖北省武汉市江夏区郑店黄金工业园路1号 

研究负责人通讯地址:

阿拉伯联合酋长国阿布扎比Shaikh Khalifa Medical City, SEHA. P.O. Box 51900 

Applicant address:

1 Golden Industrial Park Road, Zhengdian, Jiangxia District,Wuhan, Hubei, China 

Study leader's address:

Shaikh Khalifa Medical City, SEHA. P.O. Box 51900, Abu Dhabi, UAE 

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:

武汉生物制品研究所有限责任公司 

Applicant's institution:

Wuhan Institute of Biological Products co., LTD. 

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:

DOH/CVDC/2020/1311 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

阿布扎比卫生COVID19研究伦理委员会 

Name of the ethic committee:

Abu Dhabi Health COVID19 Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-07-08 

伦理委员会联系人:

Dr.Asma Alm Mannaei 

Contact Name of the ethic committee:

Dr.Asma Alm Mannaei 

伦理委员会联系地址:

PO Box 5674 Abu Dhabi ,UAE 

Contact Address of the ethic committee:

PO Box 5674 Abu Dhabi ,UAE 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+97 124493333 

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:

中国生物技术股份有限公司 

Primary sponsor:

China National Biotec Group Co.Ltd 

研究实施负责(组长)单位地址:

北京市朝阳区惠新东街4号富盛大厦2座15层 

Primary sponsor's address:

15/F, Block 2, Fusheng Building, 4 Huixin Street East, Chaoyang District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京生物制品研究所有限责任公司

具体地址:

北京市北京经济技术开发区博兴二路6号

Institution
hospital:

Beijing Institute of Biological Products Co., LTD.

Address:

6 Second Boxing Road, Beijing Economic and Technological Development Area

国家:

中国

省(直辖市):

湖北

市(区县):

Country:

China

Province:

Hubei

City:

单位(医院):

武汉生物制品研究所有限责任公司

具体地址:

湖北省武汉市江夏区郑店黄金工业园路1号

Institution
hospital:

Wuhan Institute of Biological Products co., LTD.

Address:

1 Golden Industrial Park Road, Zhengdian, Jiangxia District,Wuhan, Hubei, China

国家:

阿拉伯联合酋长国

省(直辖市):

阿布扎比

市(区县):

Country:

The Union Arab Emirates

Province:

Abu Dhabi

City:

单位(医院):

Shaikh Khalifa Medical City Dialysis Cente

具体地址:

Shaikh Khalifa Medical City Dialysis Cente

Institution
hospital:

Shaikh Khalifa Medical City Dialysis Cente

Address:

Shaikh Khalifa Medical City Dialysis Cente

经费或物资来源:

中国科技部和企业自有资金 

Source(s) of funding:

China Ministry of Science and Technology, and enterprise self-owned fund 

研究疾病:

新型冠状病毒疾病(COVID-19) 

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:

III期临床试验 

Study phase:

研究目的:

评价全程免后新型冠状病毒灭活疫苗(Vero细胞)在18岁及以上健康人群中预防新型冠状病毒所致疾病的保护效力 

Objectives of Study:

To evaluate the protective efficacy of inactivated SARS-CoV-2 Vaccine (Vero Cell) after full course of immunization in preventing diseases caused by the SARS-CoV-2 in healthy subjects aged 18 years old and above.  

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:

-年龄范围:18岁及以上健康人群; -询问病史和体格检查,经研究者判断健康状况良好; -育龄女性受试者入组时没有怀孕(尿妊娠试验阴性)、未在哺乳期且在入组后的前3个月内无生育计划;在入选前2周内已采取有效的避孕措施; -在整个研究随访期间,能够且愿意完成整个规定研究计划; 本人有能力了解研究程序,经知情同意,自愿签署知情同意书,能够遵守临床研究方案的要求。 

Inclusion criteria

1. Age range: Healthy subjects aged 18 years old and above 2. By asking for medical history and physical examination, the investigator judged that the health condition is well. 3. Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion; 4. During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan. With self-ability to understand the research procedures, the informed consent & voluntarily sign an informed consent form and be able to comply with the requirements of the clinical study protocol. 

排除标准:

-新型冠状病毒感染确诊病例、疑似病例者或无症状感染者; - 新型冠状病毒核酸检测阳性; - 有SARS、MERS病毒感染史(自报,现场问询) -接种前14天内出现发热(腋温>37.0℃)、干咳、乏力、鼻塞、流涕、咽痛、肌痛、腹泻、呼吸急促、呼吸困难症状者; -接种前腋下体温>37.0℃; -既往发生过疫苗接种严重过敏反应(如急性过敏反应、荨麻疹、呼吸困难、血管神经性水肿或腹痛)或对新型冠状病毒灭活疫苗已知成份过敏; -有惊厥、癫痫、脑病或精神疾病史或家族史; -先天畸形或发育障碍,遗传缺陷,严重营养不良等; -严重的肝肾疾病、药物不可控制的高血压(收缩压≥140mmHg,舒张压≥90mmHg)、糖尿病并发症、恶性肿瘤、各种急性疾病或慢性疾病急性发作期; -已被诊断为患有先天性或获得性免疫缺陷、HIV感染、淋巴瘤、白血病或其他自身免疫疾病; -已知或怀疑患有疾病包括:严重呼吸系统疾病、严重心血管疾病、肝肾疾病、恶性肿瘤; -有凝血功能异常史(如凝血因子缺乏,凝血性疾病); -正在接受抗-TB治疗; -3个月内接受免疫增强或抑制剂治疗者(持续口服或滴注超过14天); -接种前1个月内接种过减毒活疫苗,接种前14天内接种过其他疫苗; -接种前3个月内接受过血液制品; -接种前6个月内接受过其他研究药物; 研究者判断其他不适合参加本临床试验的情况。 

Exclusion criteria:

1. SARS-CoV-2 Infection Confirmed Cases, Suspected Cases or Asymptomatic Infection; 2. SARS-CoV-2 Nucleic acid test positive; 3. Have a history of SARS, MERS infection (self-report, on-site inquiry); 4. Fever (axillary temperature > 37.0 degree C), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination; 5. Axillary body temperature >37.0 degree C before vaccination; 6. Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred; 7. Have a history of convulsion, epilepsy, encephalopathy or mental illness or family history; 8. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; 9. Severe liver and kidney diseases, uncontrollable hypertension (systolic blood pressure >=140 mmHg, diastolic blood pressure >=90 mmHg), diabetic complications, malignant tumors, various acute diseases or acute attack period of chronic diseases; 10. Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; 11. Diseases known or suspected include severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors; 12. History of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease); 13. Receiving anti-TB therapy; 14. Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days); 15. Live attenuated vaccine is inoculated within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination; 16. Received blood products within 3 months before this vaccination; 17. Received other research drugs within 6 months before this vaccination; 18. Investigator judged other circumstances that are not suitable for this clinical trial. 

研究实施时间:

Study execute time:

From2020-07-16To 2021-07-15 

征募观察对象时间:

Recruiting time:

From2020-07-16To 2021-07-15 

干预措施:

Interventions:

组别:

对照组

样本量:

5000

Group:

Control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

Group 1

样本量:

5000

Group:

Group 1

Sample size:

干预措施:

新型冠状病毒灭活疫苗(Vero细胞)

干预措施代码:

Intervention:

Inactivated SARS-CoV-2 vaccine (Vero cell)

Intervention code:

组别:

Group 2

样本量:

5000

Group:

Group 2

Sample size:

干预措施:

新型冠状病毒灭活疫苗(Vero细胞)

干预措施代码:

Intervention:

Inactivated SARS-CoV-2 vaccine (Vero cell)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

阿拉伯联合酋长国 

省(直辖市):

阿布扎比 

市(区县):

 

Country:

UAE 

Province:

Abu Dhabi 

City:

 

单位(医院):

Shaikh Khalifa Medical City 

单位级别:

Shaikh Khalifa Medical City 

Institution
hospital:

Shaikh Khalifa Medical City  

Level of the institution:

Shaikh Khalifa Medical City 

测量指标:

Outcomes:

指标中文名:

针对COVID 19的保护效力

指标类型:

主要指标 

Outcome:

Protective efficacy against COVID 19

Type:

Primary indicator 

测量时间点:

全程免疫后14天

测量方法:

Measure time point of outcome:

14days after the full course of vaccinationf

Measure method:

指标中文名:

评价接种2剂新型冠状病毒灭活疫苗14天后预防新型冠状病毒肺炎重症病例和死亡病例的保护效力。

指标类型:

次要指标 

Outcome:

To evaluate the protective effect14 days after 2 doses of immunization of preventing severe cases of SARS-CoV-2 pneumonia and deaths accompanied by COVID-19.

Type:

Secondary indicator 

测量时间点:

全程免疫后14天

测量方法:

Measure time point of outcome:

14days after the full course of vaccinationf

Measure method:

指标中文名:

不良反应/不良事件发生情况

指标类型:

次要指标 

Outcome:

incidene of adverse reactions/events

Type:

Secondary indicator 

测量时间点:

每剂接种后30min

测量方法:

Measure time point of outcome:

within 30 minutes after each dose of vaccinationfdose of

Measure method:

指标中文名:

不良反应/不良事件发生情况

指标类型:

次要指标 

Outcome:

incidene of adverse reactions/events

Type:

Secondary indicator 

测量时间点:

每剂接种后0-7、8-21/28天

测量方法:

Measure time point of outcome:

within 3within 0-7and 8-21/28days after each dose of vaccinationfdose of

Measure method:

指标中文名:

严重不良事件( SAE)的发生率

指标类型:

次要指标 

Outcome:

Incidence of Serious Adverse Events (SAE)

Type:

Secondary indicator 

测量时间点:

首剂接种开始至全程免疫后 12个月内

测量方法:

Measure time point of outcome:

Within 12 months from first vaccination to completion of full vaccination schedule

Measure method:

指标中文名:

抗新型冠状病毒血清抗体4倍增长率和抗体水平(GMT、GMI)

指标类型:

次要指标 

Outcome:

Four-fold growth rate and antibody level (GMT, GMI) of serum antibody against COVID-19

Type:

Secondary indicator 

测量时间点:

全程免疫后14天

测量方法:

Measure time point of outcome:

14 days after full vaccination

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

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 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):

由申办方提供经检定合格的试验疫苗1、试验疫苗2和安慰剂,由第三方统计单位组织编盲,应用Stata 12.0软件,分研究中心进行编盲。试验用疫苗和对照组疫苗应随机分配序列号(每种疫苗都有唯一的序列号)。

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

The sponsor shall provide the qualified investigational vaccines and control vaccines, and the third-party statistical unit shall organize the allocation of concealment. Stata 12.0 software shall be used to generate random codes by randomization method.

盲法:

统计编盲人员编写随机分组编盲程序,制作盲底。盲底分为一次盲底和二次盲底。一次盲底为组代码,每个疫苗编号即研究号对应的试验疫苗或对照疫苗,用不同的字母表示,二次盲底将揭开最终盲底,即字母代表的疫苗名称,试验疫苗或对照疫苗。随机分组编盲程序和盲底一式二份分别装入信封,签名密封后分别保存于研究方和申办方各一份。编盲人员不得参加临床试验工作,同时也不得向参加临床试验工作的任何人员泄露编盲内容。

Blinding:

Statistical staff for allocation of concealment would write the programs for random grouping and make the blind codes. Blind codes are divided into primary blind codes and secondary blind codes. The primary blind codes are the group codes, and each vaccine number is the investigational vaccine or control vaccine corresponding to the research number, which is represented by different letters. The secondary blind codes will uncover the final blind codes, i.e. the vaccine name represented by letters, investigational vaccine or control vaccine. The random grouping allocation concealment program and blind codes are put into envelopes in duplicate, signed and sealed, and kept in one copy for the investigator and one copy for the sponsor respectively. Staff for allocation of concealment are not allowed to participate in clinical trials, nor are they allowed to disclose any content regarding the allocation of concealment to any staff participating in clinical trials.

原始数据公开时间:

The time of sharing IPD:

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):

ResMan临床试验公共管理平台

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

ResMan (www.medresman.org)

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:

电子采集和管理系统(EDC)

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

Electronic Data Capture(EDC)

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-07-18
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