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A phase II clinical trial for inactivated SARS-CoV-2 (COVID-19) Vaccine (Vero Cells)
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注册号:

Registration number:

ChiCTR2000039462 

最近更新日期:

Date of Last Refreshed on:

2020-10-28 

注册时间:

Date of Registration:

2020-10-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型冠状病毒(COVID-19)灭活疫苗(Vero细胞)Ⅱ期临床试验 

Public title:

A phase II clinical trial for inactivated SARS-CoV-2 (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免疫的安全性和免疫原性的随机、双盲、安慰剂对照Ⅱ期临床试验 

Scientific title:

Evaluation of the safety and immunogenicity of inactivated SARS-CoV-2 Vaccine (Vero Cells) in healthy population aged 18 years and above: a randomized, double-blind, placebo parallel-controlled phase II clinical trial 

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:

李贵凡 

研究负责人:

潘红星 

Applicant:

Li Guifan 

Study leader:

Pan Hongxing 

申请注册联系人电话:

Applicant telephone:

+86 010-59613591 

研究负责人电话:

Study leader's telephone:

+86 025-83759903 

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:

guifan@sohu.com 

研究负责人电子邮件:

Study leader's E-mail:

panhongxing@126.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:

北京市大兴区中关村科技园区大兴生物医药产业基地思邈路35号 

研究负责人通讯地址:

江苏省南京市江苏路172号 

Applicant address:

35 Simiao Road, Bio-medicine Industry Park, Daxing District, Beijing, China 

Study leader's address:

172 Jiangsu Road, Nanjing, Jiangsu, 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:

深圳康泰生物制品股份有限公司,北京民海生物科技有限公司 

Applicant's institution:

Shenzhen Kangtai Biological Products Co.,Ltd.; Beijing Minhai Biotechnology 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:

JSJK2020-A058-02 

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:

江苏省疾病预防控制中心伦理审查委员会 

Name of the ethic committee:

Ethic Committee of Jiangsu Provincial Center for Disease Control and Prevention 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-09-30 

伦理委员会联系人:

蔡慧媛 

Contact Name of the ethic committee:

Cai Huiyuan 

伦理委员会联系地址:

江苏省南京市江苏路172号 

Contact Address of the ethic committee:

172 Jiangsu Road, Nanjing, Jiangsu, 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:

江苏省疾病预防控制中心(江苏省公共卫生研究院) 

Primary sponsor:

Jiangsu Provincial Center for Disease Control and Prevention(Public Health Research Institute of Jiangsu Province) 

研究实施负责(组长)单位地址:

江苏省南京市江苏路172号 

Primary sponsor's address:

172 Jiangsu Road, Nanjing, Jiangsu, 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):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

深圳康泰生物制品股份有限公司

具体地址:

深圳市光明区马田街道薯田埔路18号

Institution
hospital:

Shenzhen Kangtai Biological Products Co.,Ltd.

Address:

18 Shutianpu Road, Matian Street, Guangming District, Shenzhen

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京民海生物科技有限公司

具体地址:

北京市大兴区中关村科技园区大兴生物医药产业基地思邈路35号

Institution
hospital:

Beijing Minhai Biotechnology Co., Ltd.

Address:

35 Simiao Road, Bio-medicine Industry Park, Daxing District

经费或物资来源:

自筹 

Source(s) of funding:

Self-funded 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

研究疾病代码:

 

Target disease code:

 

研究类型:

预防性研究 

Study type:

Prevention 

研究所处阶段:

II期临床试验 

Study phase:

研究目的:

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免疫的安全性和免疫原性。 

Objectives of Study:

To evaluate the safety and immunogenicity of inactivated SARS-CoV-2 Vaccine(Vero Cells) in healthy people aged 18 years 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:

1.年龄在18岁及以上常住健康人群; 2.获得志愿者的同意,并签署知情同意书; 3.志愿者能遵守临床试验方案的要求; 4.腋下体温≤37.0℃者; 5.育龄女性受试者入组时没有怀孕、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。 

Inclusion criteria

1. Healthy permanent residents aged 18 years and above; 2. Subjects agree to sign the informed consent forms voluntarily; 3. Subjects are able to comply with the requirements of the clinical trial protocol; 4. Armpit temperature <=37.0 degree C; 5. Female subjects of childbearing age were not pregnant at the time of enrollment, were not breastfeeding, and had no birth plan within the first 3 months after enrollment; effective contraceptive measures had been taken within 2 weeks before enrollment.  

排除标准:

1.接种前14天内去过境外及出现过疫情的村/社区,接触新型冠状病毒感染者或疑似病例,处于隔离期内的人员,或同村/社区内出现新型冠状病毒感染者或疑似病例; 2.新型冠状病毒感染确诊病例、疑似病例者或无症状感染者(查询中国疾病预防控制信息系统); 3.自我报告有SARS病毒感染史; 4.咽拭子RT-PCR检测结果为阳性; 5.新型冠状病毒抗体检测阳性; 6.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、皮肤湿疹、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; 7.有惊厥、癫痫、脑病或精神疾病史或家族史; 8.先天畸形或发育障碍,遗传缺陷,严重营养不良等; 9.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、严重的肝肾疾病、药物不可控制的高血压(收缩压≥140mmHg,舒张压≥90 mmHg;≥60岁受试者收缩压≥150mmHg,舒张压≥100 mmHg )、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; 10.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; 11.有凝血功能异常史(如凝血因子缺乏,凝血性疾病); 12.正在接受抗结核治疗; 13.接种前6个月内接受过其他研究药物; 14.接种前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); 15.接种前3个月内接受过血液制品; 16.接种前14天内接种过减毒活疫苗; 17.接种前7天内接种过其他疫苗; 18.研究者判断其他不适合参加本临床试验的情况。 

Exclusion criteria:

1. Within 14 days before vaccination, subjects have been abroad and to villages/communities experienced COVID-19 epidemics, and in contact with COVID-19 cases or suspected cases. Subjects are under isolation observation, or living in the villages/communities with COVID-19 cases or suspected cases; 2. Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control); 3. Subjects with history of SARS virus infection by self-reported; 4. Positive in throat swab through RT-PCR; 5. Positive in SARS-CoV-2 antibody test; 6. Subjects with history of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated SARS-CoV-2 vaccine; 7. Subjects with history of convulsion, epilepsy, encephalopathy or mental illness or family history; 8. Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; 9. Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, uncontrollable hypertension (systolic pressure >=140 mmHg, diastolic pressure >=90 mmHg; subjects aged >=60 years with systolic pressure >=150 mmHg, diastolic pressure >=100 mmHg), diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases; 10. Subjects diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; 11. Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease); 12. Subjects receiving anti-TB treatment; 13. Subjects receiving other research drugs within 6 months before vaccination; 14. Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days); 15. Subjects receiving blood products within 3 months before administration; 16. Subjects vaccinated with live attenuated vaccine within 14 days before vaccination; 17. Subjects vaccinated with other vaccine within 7 days before vaccination; 18. The researchers shall judge the other conditions which might be not in compliance with the reequipments of this clinical trial. 

研究实施时间:

Study execute time:

From2020-10-27To 2022-04-26 

征募观察对象时间:

Recruiting time:

From2020-10-27To 2021-12-31 

干预措施:

Interventions:

组别:

A1

样本量:

100

Group:

A1

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

medium dosage

Intervention code:

组别:

A2

样本量:

100

Group:

A2

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

high dosage

Intervention code:

组别:

A3

样本量:

50

Group:

A3

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

A4

样本量:

100

Group:

A4

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

medium dosage

Intervention code:

组别:

A5

样本量:

100

Group:

A5

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

high dosage

Intervention code:

组别:

A6

样本量:

50

Group:

A6

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

A7

样本量:

100

Group:

A7

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

medium dosage

Intervention code:

组别:

A8

样本量:

100

Group:

A8

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

high dosage

Intervention code:

组别:

A9

样本量:

50

Group:

A9

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

B1

样本量:

100

Group:

B1

Sample size:

干预措施:

中剂量

干预措施代码:

Intervention:

medium dosage

Intervention code:

组别:

B2

样本量:

100

Group:

B2

Sample size:

干预措施:

高剂量

干预措施代码:

Intervention:

high dosage

Intervention code:

组别:

B3

样本量:

50

Group:

B3

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

淮安 

Country:

China 

Province:

Jiangsu 

City:

Huaian 

单位(医院):

淮安市淮阴区疾病预防控制中心 

单位级别:

区疾病预防控制中心 

Institution
hospital:

Huaiyin District Center for Disease Control and Prevention, Huaian City  

Level of the institution:

District CDC 

测量指标:

Outcomes:

指标中文名:

新型冠状病毒中和抗体阳转率、抗体水平

指标类型:

主要指标 

Outcome:

The seropositive rates and level of SARS-CoV-2 neutralizing antibody

Type:

Primary indicator 

测量时间点:

全程免疫后28天

测量方法:

Measure time point of outcome:

Day 28 post full vaccination

Measure method:

指标中文名:

新型冠状病毒IgG抗体(ELISA法)阳转率

指标类型:

主要指标 

Outcome:

The seropositive rates of SARS-CoV-2 IgG antibody(tested by ELISA)

Type:

Primary indicator 

测量时间点:

全程免疫后28天

测量方法:

Measure time point of outcome:

Day 28 post full vaccination

Measure method:

指标中文名:

不良反应/事件发生率

指标类型:

次要指标 

Outcome:

Incidence of adverse reactions/events

Type:

Secondary indicator 

测量时间点:

每剂疫苗免疫后28天内

测量方法:

Measure time point of outcome:

0-28 days after each dose of vaccination

Measure method:

指标中文名:

严重不良事件

指标类型:

次要指标 

Outcome:

Serious Adverse Events(SAE)

Type:

Secondary indicator 

测量时间点:

首次免疫至全程免疫后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:

新型冠状病毒IgG抗体(ELISA法)水平

指标类型:

次要指标 

Outcome:

Level of SARS-CoV-2 IgG antibody(tested by ELISA)

Type:

Secondary indicator 

测量时间点:

全程免疫后28天

测量方法:

Measure time point of outcome:

Day 28 post full vaccination

Measure method:

指标中文名:

新型冠状病毒中和抗体、IgG抗体(ELISA法)阳转率和抗体水平

指标类型:

次要指标 

Outcome:

The seropositive rates and level of SARS-CoV-2 neutralizing antibody and IgG antibody(tested by ELISA)

Type:

Secondary indicator 

测量时间点:

3剂免疫程序组第2剂免疫后28天,2剂免疫程序组全程免疫后14天

测量方法:

Measure time point of outcome:

Day 28 after the second dose of the 3 doses group, and day 14 after the full immunization of the 2 doses group

Measure method:

指标中文名:

新型冠状病毒中和抗体、IgG抗体(ELISA法)阳性率和抗体水平

指标类型:

次要指标 

Outcome:

The seropositive rates and level of SARS-CoV-2 neutralizing antibody and IgG antibody(tested by ELISA)

Type:

Secondary indicator 

测量时间点:

全程免疫后3个月、6个月、12个月

测量方法:

Measure time point of outcome:

3, 6 and 12 months post 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

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet 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):

由随机化统计师应用SAS 9.4或以上版本软件产生随机盲底。18-59岁和≥60岁各免疫程序组均按2:2:1的比例将受试者随机分配至中剂量疫苗组、高剂量疫苗组和安慰剂组。

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

Randomized statisticians use SAS version 9.4 or above to generate random blinding code. In each age and dose group, subjects were divided into medium dosage, high dosage and placebo at a ratio of 2:2:1.

盲法:

未说明

Blinding:

Not stated

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):

根据要求

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

upon 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:

EDC

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

EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-10-28
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