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A randomized, double-blinded, placebo-controlled phase II clinical trial for Recombinant Novel Coronavirus (2019-nCOV) Vaccine (Adenovirus Vector)
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注册号:

Registration number:

ChiCTR2000031781 

最近更新日期:

Date of Last Refreshed on:

2020-04-10 

注册时间:

Date of Registration:

2020-04-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

重组新型冠状病毒(2019-nCOV)疫苗(腺病毒载体)随机、双盲、安慰剂对照设计的Ⅱ期临床试验 

Public title:

A randomized, double-blinded, placebo-controlled phase II clinical trial for Recombinant Novel Coronavirus (2019-nCOV) Vaccine (Adenovirus Vector) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

在18周岁及以上健康成人中开展重组新型冠状病毒(2019-nCOV)疫苗(腺病毒载体)随机、双盲、安慰剂对照设计的Ⅱ期临床试验 

Scientific title:

A randomized, double-blinded, placebo-controlled phase II clinical trial for Recombinant Novel Coronavirus (2019-nCOV) Vaccine (Adenovirus Vector) in healthy adults aged above 18 years 

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:

侯利华 

研究负责人:

朱凤才 

Applicant:

Hou Lihua 

Study leader:

Zhu Fengcai 

申请注册联系人电话:

Applicant telephone:

+86 010-66948565 

研究负责人电话:

Study leader's telephone:

+86-025-83759418 

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:

houlihua@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

jszfc@sina.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:

北京市丰台区东大街20号 

研究负责人通讯地址:

江苏省南京市鼓楼区江苏路172号 

Applicant address:

20 Dongda Street, Fengtai District, Beijing, China 

Study leader's address:

172 Jiangsu Road, Gulou District, Nanjing District, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

100071 

研究负责人邮政编码:

Study leader's postcode:

210009 

申请人所在单位:

军事科学院军事医学研究院生物工程研究所 

Applicant's institution:

Insitute of Biotechnology, Academy of Military Medical Sciences, PLA of China 

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-A019-01 

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:

Ethics Committee of Jiangsu Provical Center for Disease Control and Prevention 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-08 

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:

江苏省南京市鼓楼区江苏路172号 

Contact Address of the ethic committee:

172 Jiangsu Road, Gulou District, Nanjing District, Jiangsu, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 025-83759406 

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 

Primary sponsor:

Jiangsu Provincial Center for Disease Control and Prevention 

研究实施负责(组长)单位地址:

江苏省南京市鼓楼区江苏路172号 

Primary sponsor's address:

172 Jiangsu Road, Gulou District, Nanjing District, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

军事科学院军事医学研究院生物工程研究所

具体地址:

北京市丰台区东大街20号

Institution
hospital:

Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

Address:

20 Dongda Street, Fengtai District

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tanjin

City:

单位(医院):

康希诺生物股份公司

具体地址:

天津经济技术开发区西区南大街185号

Institution
hospital:

CanSino Biologics Inc.

Address:

5 South Avenue, West District of TEDA

经费或物资来源:

中国国家科技部 

Source(s) of funding:

Ministry of Science and Technology, China  

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:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

II期临床试验 

Study phase:

研究目的:

评价18周岁及以上健康成人接种重组新型冠状病毒疫苗(腺病毒载体)的免疫原性和安全性。 

Objectives of Study:

Evaluation of safety and immunogenicity for Recombinant Novel Coronavirus Disease Vaccine (Adenovirus Vector) in healthy adults aged above 18 years 

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周岁及以上。 2.获得受试者的知情同意,并签署知情同意书。 3.受试者能够并愿意遵守临床试验方案的要求,并且能完成6个月的研究随访。 4.HIV筛查阴性。 5.腋下体温≤37.0℃。 6.2019新型冠状病毒抗体(IgG和IgM)筛查阴性。 7.BMI指数18.5-30.0。 8.经查问病史、体检和临床判定健康者,符合本制品免疫接种的受试者。 

Inclusion criteria

1. Aged above 18 years; 2. Able to understand the content of informed consent and willing to sign the informed consent; 3. Able and willing to complete all the secluded study process during the whole follow-up period of 6 months. 4. Negative in HIV diagnostic test; 5. Axillary temperature <=37.0 degree C; 6. Negative in serum antibodies (IgG and IgM) screening of COVID-19. 7. The BMI index 18.5-30.0; 8. General good health as established by medical history and physical examination. 

排除标准:

1. 有惊厥、癫痫、脑病和精神病等病史或家族史者。 2. 对研究疫苗中任何成份过敏者,过去有较严重的疫苗过敏反应,过敏史。 3. 女性尿妊娠试验阳性者,怀孕、在哺乳期的妇女,或在6个月内有怀孕计划的妇女。 4. 急性发热性疾病者及传染病者。 5. 有SARS病史者。 6. 患有较严重的心血管疾病,如心律失常、传导阻滞、心肌梗塞、严重高血压且药物无法控制等。 7. 患有严重慢性疾病或病情处于进展期不能平稳控制,如哮喘、糖尿病、甲状腺疾病等。 8. 先天或获得性的血管性水肿/神经性水肿。 9. 接受试验疫苗前1年有患荨麻疹。 10. 无脾或功能性无脾。 11. 患血小板减少症或其他凝血障碍(可能造成肌内注射禁忌)。 12. 晕针者。 13. 过去6个月内有过免疫抑制剂治疗、抗过敏治疗、细胞毒性治疗、吸入皮质类固醇(不包括过敏性鼻炎的皮质类固醇喷雾治疗,急性非并发皮炎的表面皮质类固醇治疗)。 14. 接受试验疫苗前4个月内接受过血液制品。 15. 接受试验疫苗前1个月内接受过其他研究药物。 16. 接受试验疫苗前1个月内接受过减毒活疫苗。 17. 接受试验疫苗前14天内接受过亚单位或灭活疫苗。 18. 正在接受抗结核治疗。 19. 根据研究者判断,由于各种医疗、心理、社会条件或其他条件,有悖于试验方案,或影响受试者签署知情同意的。 

Exclusion criteria:

1. Family history of seizure, epilepsy, brain or mental disease; 2. Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past; 3. Woman who is pregnant, breast-feeding or positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months; 4. Any acute fever disease or infections; 5. History of SARS; 6. Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease; 7. Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc.; 8. Hereditary angioneurotic edema or acquired angioneurotic edema; 9. Urticaria in last one year; 10. No spleen or functional spleen; 11. Platelet disorder or other bleeding disorder may cause injection contraindication; 12. Faint at the sight of needles; 13. Prior administration of immunodepressant or corticosteroids,antianaphylaxis treatment, cytotoxic treatment in last 6 months; 14. Prior administration of blood products in last 4 months; 15. Prior administration of other research medicines in last 1 month; 16. Prior administration of attenuated vaccine in last 1 month; 17. Prior administration of inactivated vaccine in last 14 days; 18. Current anti-tuberculosis prophylaxis or therapy; 19. According to the judgement of investigator,various medical, psychological,social or other conditions, those could affect the subjects to sign informed consent. 

研究实施时间:

Study execute time:

From2020-04-12To 2021-01-31 

征募观察对象时间:

Recruiting time:

From2020-04-09To 2020-06-30 

干预措施:

Interventions:

组别:

1

样本量:

250

Group:

1

Sample size:

干预措施:

中剂量组(1E11vp)

干预措施代码:

Intervention:

Middle dose (1E11vp)

Intervention code:

组别:

2

样本量:

125

Group:

2

Sample size:

干预措施:

低剂量组(5E10vp)

干预措施代码:

Intervention:

Low dose (5E10vp)

Intervention code:

组别:

3

样本量:

125

Group:

3

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):

湖北省 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

中国人民武装警察部队武汉特勤疗养中心 

单位级别:

 

Institution
hospital:

Wuhan Rest Center,Chinese People's Armed Police Force  

Level of the institution:

 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

湖北省疾病预防控制中心 

单位级别:

 

Institution
hospital:

HubeiProvincial Center for Disease Control and Prevention  

Level of the institution:

 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉大学中南医院 

单位级别:

三甲医院 

Institution
hospital:

Zhongnan Hospital of Wuhan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

免疫后0-14天不良反应(AR)

指标类型:

主要指标 

Outcome:

Adverse reactions 0-14 days post vaccination

Type:

Primary indicator 

测量时间点:

接种后14天内

测量方法:

观察、检测

Measure time point of outcome:

0-14 day post vaccination

Measure method:

Observasion and test

指标中文名:

免疫后第28天抗2019新型冠状病毒的S蛋白特异性抗体滴度(ELISA法)

指标类型:

主要指标 

Outcome:

Anti-S antibody IgG titer on day 28 post vaccination

Type:

Primary indicator 

测量时间点:

接种后28天

测量方法:

检测

Measure time point of outcome:

On day 28 post vaccination

Measure method:

Test

指标中文名:

免疫后第28天抗2019新型冠状病毒特异性中和抗体滴度

指标类型:

主要指标 

Outcome:

Anti-SARS-CoV-2 neutralizing antibody titer on day 28 post vaccination

Type:

Primary indicator 

测量时间点:

接种后28天

测量方法:

检测

Measure time point of outcome:

on day 28 post vaccination

Measure method:

Test

指标中文名:

免疫后0-28天不良事件(AE)

指标类型:

次要指标 

Outcome:

Adverse reactions 0- 28 days post vaccination

Type:

Secondary indicator 

测量时间点:

接种后28天内

测量方法:

观察、检测

Measure time point of outcome:

Within 28 days post vaccination

Measure method:

Observasion and test

指标中文名:

免疫后6个月内严重不良事件

指标类型:

次要指标 

Outcome:

SAE within 6 months post vaccination

Type:

Secondary indicator 

测量时间点:

接种后6个月内

测量方法:

观察、检测

Measure time point of outcome:

Within 6 months post injection

Measure method:

Observasion and test

指标中文名:

免疫后第14天、6个月抗2019新型冠状病毒的S蛋白特异性抗体滴度(ELISA法)

指标类型:

次要指标 

Outcome:

Anti-S antibody IgG titer on day 14, month 6 post vaccination

Type:

Secondary indicator 

测量时间点:

接种后14天、6个月

测量方法:

检测

Measure time point of outcome:

On day 14, month 6 after vaccination

Measure method:

Test

指标中文名:

免疫后第14天、6个月抗2019新型冠状病毒特异性中和抗体滴度

指标类型:

次要指标 

Outcome:

Anti-SARS-CoV-2 neutralizing antibody titer on day 14,month 6 post vaccination

Type:

Secondary indicator 

测量时间点:

接种后14天、6个月

测量方法:

检测

Measure time point of outcome:

On day 14, month 6 after vaccination

Measure method:

Test

指标中文名:

免疫后第28天、第6个月抗Ad5载体的特异性中和抗体滴度

指标类型:

次要指标 

Outcome:

Anti-Ad5 neutralizing antibody on day 28 and 6 month post vaccination

Type:

Secondary indicator 

测量时间点:

接种后28天、6个月

测量方法:

检测

Measure time point of outcome:

On day 28, month 6 after vaccination

Measure method:

Test

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:

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):

本研究采用对试验用疫苗进行编盲的方法实现随机与盲法

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

The randomized and blinded methods were used to blind experimental vaccines

盲法:

双盲

Blinding:

Double blinding

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

手工

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

manual

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:

 2020-04-10
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