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A Phase II clinical trial of novel coronavirus pneumonia (COVID-19) mRNA Vaccine (BNT162b2) in China
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注册号:

Registration number:

ChiCTR2000040044 

最近更新日期:

Date of Last Refreshed on:

2020-11-19 

注册时间:

Date of Registration:

2020-11-19 

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) mRNA疫苗(BNT162b2)中国II期临床试验 

Public title:

A Phase II clinical trial of novel coronavirus pneumonia (COVID-19) mRNA Vaccine (BNT162b2) in China 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

SARS-CoV-2 mRNA疫苗(BNT162b2) 在中国健康人中的 安全性和免疫原性:随机、安慰剂对照、观察者盲II期研究 

Scientific title:

Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population: A Phase II, Randomized, Placebo-controlled, Observer-blind Study 

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:

王维 

研究负责人:

朱凤才 

Applicant:

Wang Wei 

Study leader:

Zhu Fengcai 

申请注册联系人电话:

Applicant telephone:

+86 18601136155 

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:

wangwei9@fosunpharma.com 

研究负责人电子邮件:

Study leader's E-mail:

iszfc@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:

北京市朝阳区朝阳北路237号复星国际中心23层 

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:

237 North Chaoyang Road, Chaoyang District, Beijing, China 

Study leader's address:

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

北京复星医药科技开发有限公司 

Applicant's institution:

Beijing Fosun Pharmaceutical Research and Development 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-A038-01 

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 Provincial Center for Disease Prevention and Control 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-11-16 

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, Jiansu, 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 

Primary sponsor:

Jiangsu Provincial Center for Disease Prevention and Control 

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, Jiansu, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

德国

省(直辖市):

Mainz

市(区县):

Country:

Germany

Province:

Mainz

City:

单位(医院):

BioNTech SE

具体地址:

An der Goldgrube 12

Institution
hospital:

BioNTech SE

Address:

An der Goldgrube 12

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海复星医药产业发展有限公司

具体地址:

中国上海市宜山路1289号

Institution
hospital:

Shanghai Fosun Pharmaceutical Development, Inc.

Address:

1289 Yishan Road, Shanghai

经费或物资来源:

上海复星医药产业发展有限公司 

Source(s) of funding:

Shanghai Fosun Pharmaceutical Development, Inc. 

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:

主要目的:描述中国健康受试者在BNT162b2预防性疫苗第2剂接种1个月后的体液免疫应答。 次要目的:1)观察直至研究结束,中国健康受试者接种BNT162b2的体液免疫应答。2)在每次接种后7天和14天内,观察间隔21天给予BNT162b2或安慰剂的安全性和耐受性特征。3)观察直至研究结束,BNT162b2在中国健康受试者中接种的安全性。 

Objectives of Study:

Primary Objectives: To describe the humoral immune responses to BNT162b2 prophylactic vaccine in Chinese healthy participants at 1-month post Dose 2. Secondary Objectives: 1) To observe the humoral immune response in Chinese healthy participants vaccinated with BNT162b2 until the end of study. 2) Within 7 days and 14 days post each vaccination, to observe the safety and tolerability profile of BNT162b2 or placebo given 21 days apart. 3) To observe the safety of BNT162b2 vaccination in Chinese healthy participants until the end of study. 

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. 随机时,年龄18~85岁(含)的男性或女性受试者。 2. 受试者愿意并能够遵守所有预定的访视、疫苗接种计划、实验室检查、生活方式考虑和其他研究程序。 3. 根据病史、体格检查(如需要)和研究者的临床判断,确定符合纳入研究条件的健康受试者。 注:健康的、既往有稳定疾病(定义为在入组前6周内不需要显著改变治疗或因病情恶化而住院的疾病)的受试者也可以纳入。 4. 能够给予个人签署的知情同意,包括遵守知情同意书和本方案中列出的要求和限制。 5. SARS-CoV-2抗体筛查阴性。 6. 通过RT-PCR检测咽拭子的SARS-CoV-2检测结果为阴性(仅约前150例受试者)。 7. 胸部CT正常(无COVID-19的影像学特征,仅约前150例受试者)。 

Inclusion criteria

1. Male or female participants between the ages of 18 and 85 years, inclusive, at randomization; 2. Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures; 3. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study; Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included; 4. Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol; 5. SARS-CoV-2 antibody test screening is negative; 6. Negative SARS-CoV-2 test in throat swabs by RT-PCR (only for the first approximately 150 subjects); 7. Normal in chest CT scans (no imaging features of COVID-19, only for the first approximately 150 subjects). 

排除标准:

1. 其他医疗或精神状况,包括最近(过去一年内)或目前存在的自杀意念/行为,或可能增加参与研究的风险的实验室异常,或根据研究者的判断受试者不适合参与研究。 2. 已知感染了人体免疫缺陷病毒(HIV)、丙型肝炎病毒(HCV)或乙型肝炎病毒(HBV)。 3. 与疫苗相关的严重不良反应史和/或对研究疫苗的任何组分有严重过敏性反应(如全身过敏反应)史。 4. 接受预防COVID-19的药物。 5. 经病史和/或实验室/体检确定的已知或疑似免疫缺陷的免疫功能低下者。 6. 与延长出血相关的出血体质或状况,研究者认为肌肉注射是禁忌的。 7. 孕妇或哺乳期妇女。或一年内计划怀孕的妇女或其伴侣。 8. 以前接种过冠状病毒疫苗。 9. 接受免疫抑制治疗者,包括细胞毒性药物或全身皮质类固醇,如治疗癌症或自身免疫性疾病,或在整个研究期间计划接受治疗。如果为急性疾病的治疗而在短期内(<14天)使用了全身皮质类固醇,则在进行研究接种前,受试者应在皮质类固醇治疗停止至少28天后才可进入本研究。允许吸入/喷雾、关节内、骨内或局部(皮肤或眼睛)使用皮质类固醇。 10. 在研究接种前60天已接受或整个研究期间计划接受血液/血浆产品或免疫球蛋白。 11. 在进入研究前28天内和/或在研究参与期间参与其他涉及干预性研究。 12. 参与其他含脂质纳米颗粒的干预性研究。 13. 在筛选访视前30天内,接触过COVID-19确诊患者或者SARS-CoV-2检测阳性者。 14. 在筛选访视前14天内,任何SARS-CoV-2感染风险高的国家或地区(按照筛选访视时的定义)旅行史或居住史。 15. 具有COVID-19症状,如呼吸症状、发热、咳嗽、呼吸急促和呼吸困难。 16. 发热,腋窝温度≥37.3℃或口腔温度≥38.0℃。 17. 有SARS,SARS-CoV-2或MERS感染史。疑似SARS感染者应筛查SARS抗体。 18. 研究工作人员或直接参与研究的复星员工,研究者下属的研究中心员工及其各自的家庭成员。 

Exclusion criteria:

1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigators judgment, make the participant inappropriate for the study; 2. Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV); 3. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s); 4. Receipt of medications intended to prevent COVID-19; 5. Immunocompromised individuals with known or suspected immunodeficiency, determined by history and/or laboratory/physical examination; 6. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection; 7. Women who are pregnant or breastfeeding; 8. Previous vaccination with any coronavirus vaccine; 9. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted; 10. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study; 11. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation; 12. Previous participation in other studies involving study intervention containing lipid nanoparticles; 13. Have had contact with confirmed COVID-19 patients or persons tested positive for SARS-CoV-2 within the 30 days prior to Screening Visit; 14. Travel or live in any country or region with a high SARS-CoV-2 infection risk (as defined at Screening Visit) within the 14 days prior to Screening Visit; 15. Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath and breathing difficulties; 16. Fever, defined as axillary temperature >=37.3 degree C or oral temperature >= 38.0 degree C; 17. History of SARS, SARS-CoV-2 or MERS infection. Suspected SARS patients should be screened for SARS antibodies; 18. Investigator site staff or Fosun employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. 

研究实施时间:

Study execute time:

From2020-11-23To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2020-11-20To 2020-12-31 

干预措施:

Interventions:

组别:

1

样本量:

720

Group:

1

Sample size:

干预措施:

BNT162b2

干预措施代码:

Intervention:

BNT162b2

Intervention code:

组别:

2

样本量:

240

Group:

2

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):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

泰州市疫苗临床研究中心 

单位级别:

 

Institution
hospital:

Taizhou Vaccine Clinical Research Center  

Level of the institution:

 

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

涟水县疾病预防控制中心 

单位级别:

 

Institution
hospital:

Lianshui County Center for Disease Control and Prevention  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

SARS-CoV-2血清中和抗体的血清阳转率(SCR)

指标类型:

主要指标 

Outcome:

Seroconversion rates (SCR) of SARS-CoV-2 serum neutralizing titers

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SARS-CoV-2血清中和抗体滴度的几何平均滴度(GMT)

指标类型:

主要指标 

Outcome:

Geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing titers

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SARS-CoV-2 anti-S1 IgG抗体水平的SCR

指标类型:

次要指标 

Outcome:

SCR of SARS-CoV-2 anti-S1 IgG antibody

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SARS-CoV-2 anti-S1 IgG抗体水平的GMT

指标类型:

次要指标 

Outcome:

GMT of SARS-CoV-2 anti-S1 IgG antibody

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SARS-CoV-2血清中和抗体滴度的几何平均增长倍数(GMFR)

指标类型:

次要指标 

Outcome:

Geometric mean fold rise (GMFR) of SARS-CoV-2 serum neutralizing antibody titers

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SARS-CoV-2 anti-S1 IgG抗体水平的GMFR

指标类型:

次要指标 

Outcome:

GMFR of SARS-CoV-2 anti-S1 IgG antibody

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

局部事件

指标类型:

次要指标 

Outcome:

Local reactions

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全身事件

指标类型:

次要指标 

Outcome:

Systemic events

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血液和生化检查值异常

指标类型:

次要指标 

Outcome:

Abnormal hematology and chemistry laboratory values

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

次要指标 

Outcome:

Adverse events

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:

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:

使用后销毁

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 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):

由独立的随机化专业人员通过SAS9.4或以上版本生成受试者随机表,并导入交互响应技术(IRT)系统,仅授权人员才能访问。

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

The random table of subjects will be generated by an independent randomized professional through SAS9.4 or above, and will be imported to the interactive response technology (IRT) system, which could only be accessed by authorized personnel.

盲法:

Blinding:

是否共享原始数据:

IPD sharing

Yes

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:

EDC

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

EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-11-19
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