Today is 2020-09-23

A Phase I clinical trial of novel coronavirus pneumonia (COVID-19) mRNA Vaccine (BNT162b1) in China
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注册号:

Registration number:

ChiCTR2000034825 

最近更新日期:

Date of Last Refreshed on:

2020-09-10 

注册时间:

Date of Registration:

2020-07-21 

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(BNT162b1)中国I期临床试验 

Public title:

A Phase I clinical trial of novel coronavirus pneumonia (COVID-19) mRNA Vaccine (BNT162b1) 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(BNT162b1) 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I期研究 

Scientific title:

Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects: A Phase I, 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:

jszfc@jscdc.cn 

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, 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:

210009 

申请人所在单位:

100026 

Applicant's institution:

北京复星医药科技开发有限公司 

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:

SL2020-A038-06 

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:

2020-08-07 

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, 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 

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 RNA Pharmaceuticals GmbH

具体地址:

An der Goldgrube 12

Institution
hospital:

BioNTech RNA Pharmaceuticals GmbH

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:

I期临床试验 

Study phase:

研究目的:

主要目的: 在未感染SARS-CoV-2的中国健康人中,评价间隔21天给予不同剂量BNT162b1初次/加强(P/B)免疫,直至加强接种后28天的安全性和耐受性特征。 次要目的: 1)通过酶联免疫吸附法(ELISA),观察间隔21天给予两次BNT162b1的免疫原性(anti-S1和anti-RBD IgG抗体)。 2)通过基于真病毒的SARS-CoV-2中和抗体检测方法,观察BNT162b1 P/B免疫后健康人的免疫反应性。 3)观察直至研究结束,BNT162b1在中国健康人中接种的安全性。 4)对BNT162b1接种剂量队列(包括安慰剂和BNT162b1亚组)中健康人进行长达12个月随访,观察对BNT162b1的免疫应答持久性。 

Objectives of Study:

Primary objective To evaluate the safety and tolerability profiles of BNT162b1 prime/boost (P/B) immunization given 21 days apart from different doses in SARS-CoV-2 na?ve Chinese healthy subjects through 28 days after boost vaccination. Secondary objectives 1) To observe the immunogenicity (anti-S1 and anti-RBD IgG antibody) of two doses of BNT162b1 given 21 days apart measured by enzyme-linked immunosorbent assay (ELISA). 2) To observe the immunoreactivity of healthy subjects after BNT162b1 P/B immunization by the true virus-based SARS-CoV-2 neutralizing antibody assay. 3) To observe the safety of BNT162b1 vaccination in Chinese healthy subjects until the end of the study. 4) To conduct 12-month follow-up for healthy subjects in the BNT162b1 vaccination dose cohorts (including placebo and BNT162b1 subgroups), and observe the sustainability of the immune response to BNT162b1. 

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. 筛选访视时,受试者年龄≥18岁且≤55岁,体重指数(BMI)≥18且≤30,(老年受试者:年龄>55岁),男性或女性受试者。 2. 根据病史、体格检查(包括生命体征、ECG)和合格性筛选检查(血液学、生化和尿液分析)以及筛选访视时研究者的临床判断,确定入组试验时健康状况良好的个体。(老年受试者:确定入组试验时健康状况可以接受研究疫苗接种) 3. 开始试验程序前,受试者签署书面知情同意书(ICF)并注明日期。 4. 必须能够理解和遵循与试验有关的指示。 5. 必须愿意并能够遵守计划的访视、治疗时间表、实验室检查和试验的其他要求。 6. SARS-CoV-2抗体筛查阴性(指尖血)。 7. 胸部CT正常(老年受试者:无COVID-19的影像学特征)。 8. 腋下温度≤37.0oC。 9. 通过RT-PCR检测咽拭子的SARS-CoV-2检测结果为阴性。 10. 在筛选访视时,有生育能力的女性(WOCBP)血β-hCG检测必须呈阴性。绝经后(连续停经超过12个月)或永久绝育的女性将被视为没有生殖潜力。 11. WOCBP必须在筛选前14天已经采用了有效的避孕措施,并同意在试验期间继续采用有效的避孕措施,从筛选访视前14天持续到接受最后一次免疫后60天。 12. WOCBP必须同意在试验期间不捐赠卵子(卵细胞,卵母细胞)用于辅助生殖,从筛选访视开始持续到接受最后一次免疫后60天。 13. 与WOCBP有性行为的男性,如果没有接受输精管切除术,必须同意在试验期间与有生育潜力的女性伴侣采用有效的避孕方式,从筛选访视开始持续到接受最后一次免疫后60天。 14. 男性必须愿意避免捐精,从筛选访视开始持续到接受最后一次免疫后60天。 

Inclusion criteria

1. Male or female subjects aged 18 to 55 years old with body mass index (BMI) 18 to 30 at the Screening Visit. For the elderly subjects, aged >55 years old at Screening Visit; 2. Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination (including vital signs, ECG) and eligibility screening test (hematology, blood chemistry and urine analysis) and clinical judgment of the investigator at Screening Visit. For the elderly subjects, individuals who are in a health condition that can receive the investigation vaccine; 3. The subject can provide with informed consent and signs and dates a written informed consent form (ICF) prior to the initiation of any trial procedures; 4. They must be able to understand and follow trial-related instructions; 5. They must be willing and able to comply with planned visits, treatment schedule, laboratory tests and other requirements of the trial; 6. Negative in antibodies screening of SARS-CoV-2 (fingerstick); 7. Normal in chest CT scans (no imaging features of COVID-19). For the elderly subjects, No imaging features of COVID-19 in chest CT; 8. Axillary temperature <=37.0 degree C; 9. Negative SARS-CoV-2 test in throat swabs by RT-PCR; 10. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (beta-hCG) in serum sample at Screening Visit. Women that are postmenopausal (Menopause>=12 consecutive months) or permanently sterilized will be considered as not having reproductive potential; 11. WOCBP must have used effective contraception 14 days prior to screening and agree to use effective contraception continuously during the trial period, from 14 days prior to Screening Visit to 60 days after the last immunization; 12. WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting from Screening Visit and continuously until 60 days after be given the last immunization; 13. Men who are sexually active with a WOCBP and have not had a vasectomy must agree to practice a effective form of contraception with their female partner of childbearing potential during the trial, starting from Screening Visit and continuously until 60 days after be given the last immunization; 14. Men must be willing to refrain from sperm donation, starting from Screening Visit and continuously until 60 days after receiving the last immunization. 

排除标准:

1. 老年组:筛选访视时通过体格检查和合格性筛查,发现基线实验室异常≥3级(根据附录B的分级标准); 2. 在初次接种前72小时内,由研究者确定,曾患有任何急性疾病,无论是否发烧。如果研究者认为,作为受试者参与试验,残余症状不会损害他们的健康,不会妨碍、限制或混淆试验方案规定的评估,则几乎痊愈仅剩轻微残余症状的急性疾病是允许的。 3. (成年组)在筛选访视当天或计划在试验期间母乳喂养的人,从筛选访视开始持续到接受最后一次免疫后至少90天。筛选访视访视1年内计划怀孕的女性或伴侣。 4. 已知对计划的研究用疫苗(包括任何辅料)有过敏、超敏反应或不耐受。 5. 曾经对疫苗接种有过敏或严重反应病史。 6. 在访视1前4周内接受过任何疫苗。 7. 受试者不同意在试验期间避免接种其他疫苗,从筛选访视开始持续至接受末次免疫接种后28天,紧急接种除外(例如狂犬病疫苗、破伤风疫苗)。 8. 在过去5年内有任何医疗状况(如自身免疫性疾病)或任何重大手术(例如,需要全身麻醉),如果研究者认为,作为受试者参与试验可能会损害他们的健康,或者可能会妨碍、限制或混淆试验方案规定的评估。(老年组:严重或危及生命) 9. 在试验期间有任何手术计划,从筛选访视开始持续到接受最后一次免疫后至少90天。 10. 在筛选访视前6个月内长期使用影响免疫功能的全身性药物,包括免疫抑制剂或其他免疫调节剂(连续超过14天),除非研究者认为药物不会妨碍、限制或混淆试验方案规定的评估,或可能危及受试者的安全。 11. 在筛选访视前3个月内使用任何免疫球蛋白和/或任何血液制品。 12. 在筛选访视前60天或5个半衰期内(以较长时间为准)使用另一种研究药物,包括疫苗。 13. 已知的艾滋病病史或HIV 筛查呈阳性。 14. 有HBV或HCV感染史。 15. 既往感染过SARS、SARS-CoV-2或MERS。疑似SARS感染者应筛查SARS抗体。 16. 曾参与一项涉及脂质纳米粒的研究试验。 17. 在其他研究试验的排除期,或同时参与另一项临床试验。 18. 与研究中心有任何从属关系(例如,是研究者的近亲或下属,如研究中心的雇员或学生)。 19. 在过去5年内,有药物滥用史或已知的医疗、心理或社会状况。研究者认为,如果作为受试者参与试验,上述情况可能会损害他们的健康,或可能会妨碍、限制或混淆试验方案规定的评估。 20. 有嗜睡症病史。 21. 在筛选访视前1年内有酗酒或吸毒史。 22. 根据筛选访视时的病史和/或体格检查判断,有后天或先天性的疑似免疫抑制病史。 23. 有任何异常或永久性身体艺术(例如纹身),研究者认为这将妨碍观察接种部位局部反应。 24. 在筛选访视前28天内有任何失血>400 mL(例如,捐献血液或血液制品或受伤),或计划在试验期间捐献血液或血浆(从筛选访视开始,持续到接受最后一次免疫后至少28天)。 25. 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。 26. 从筛选访视到接受最后一次免疫后14天,计划访问任何SARS-CoV-2感染风险高的国家或地区(按照筛选访视时的定义)。 27. 具有COVID-19症状,如呼吸症状、发烧、咳嗽、呼吸急促和呼吸困难。 28. 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。 29. 属于弱势人员,如士兵、被拘留者、CRO、申办方人员或其家属。 

Exclusion criteria:

1. For the elderly subjects, Baseline laboratory abnormalities with Grade >=3 (according to the grading criteria in appendix B) during screening visits, by physical examination and eligibility screening; 2. Have had any acute illness, as determined by the investigator, with or without fever, within 72 h prior to the prime vaccination. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the investigator, the residual symptoms will not compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments; 3. Are breastfeeding on the day of Screening Visit or who plan to breastfeed during the trial, starting from Screening Visit and continuously until at least 90 days after the last immunization. Women or partners who plan to become pregnant within 1 year post the screening visit; 4. Have a known allergy, hypersensitivity, or intolerance to the planned vaccine for trial including any excipients; 5. Had a history of hypersensitivity or serious reactions to vaccination; 6. Received any vaccination within 4 weeks prior to Visit 1. 7. Disagree for do not receive other vaccine during the trial, starting from Screening Visit and continuously until 28 days after receiving the last immunization, except emergency vaccination (e.g. rabies vaccine, tetanus vaccine); 8. Had any medical condition (e.g., autoimmune disease) or any major surgery (e.g., requiring general anesthesia) within the past 5 years, which in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments. For the elderly subjects, Had any serious or life-threatening medical condition (e.g., autoimmune disease, cardiovascular disease) within the past 5 years, which in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments; 9. Have any surgery planned during the trial, starting from Screening Visit and continuously until at least 90 days after the last immunization; 10. Had any chronic use (more than 14 continuous days) of any systemic medications that affects immune function, including immunosuppressant or other immune-modifying drugs, within 6 months prior to Screening Visit unless in the opinion of the investigator, the medication would not prevent, limit, or confound the protocol-specified assessments or could compromise safety of subjects; 11. Had administration of any immunoglobulins and/or any blood products within the 3 months prior to Screening Visit. 12. Had administration of another investigational product including vaccines within 60 days or 5 half-lives (whichever is longer), prior to Screening Visit; 13. With known history of AIDS or HIV test positive; 14. History of HBV or HCV infection, through medical inquiry; 15. History of SARS, SARS-CoV-2 or MERS infection. Suspected SARS patients should be screened for SARS antibodies. 16. Previously participated in a clinical trial involving lipid nanoparticles; 17. Are subject to exclusion periods of other clinical trials or simultaneous participation in another clinical trial; 18. Have any affiliation with the study site (e.g., are close relative of the investigator or dependent person, such as an employee or student of the study site); 19. Have a history of drug abuse or known medical, psychological, or social conditions within the past 5 years. In the opinion of the investigator, could comprise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments; 20. Have a history of narcolepsy; 21. Have history of alcohol abuse or drug addiction within 1 year prior to Screening Visit; 22. Have a history of or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination at Screening Visit; 23. Have any abnormality or permanent body art (e.g., tattoo), in the opinion of the investigator, would obstruct the ability to observe local reactions at the vaccination site; 24. Have had any blood loss >400 mL, e.g., due to donation of blood or blood products or injury, within the 28 days prior to Screening Visit or plan to donate blood or plasma during the trial, starting from Screening Visit and continuously until at least 28 days after be given the last immunization; 25. 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; 26. They plan to visit any country or region with a high SARS-CoV-2 infection risk (as defined at Screening Visit), from Screening Visit until 14 days after be given the last immunization; 27. Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath and breathing difficulties; 28. Have had contact with confirmed COVID-19 patients or persons tested positive for SARS-CoV-2 within the 30 days prior to Screening Visit; 29. Are vulnerable persons, e.g., soldiers, subjects in detention, CRO or Fosun staffs or their family members. 

研究实施时间:

Study execute time:

From2020-07-20To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2020-07-20To 2020-12-31 

干预措施:

Interventions:

组别:

1

样本量:

24

Group:

1

Sample size:

干预措施:

成年组-低剂量

干预措施代码:

Intervention:

Adult-Low dose

Intervention code:

组别:

2

样本量:

24

Group:

2

Sample size:

干预措施:

成年组-高剂量

干预措施代码:

Intervention:

Adult-High dose

Intervention code:

组别:

3

样本量:

24

Group:

3

Sample size:

干预措施:

成年组-安慰剂

干预措施代码:

Intervention:

Adult-Placebo

Intervention code:

组别:

4

样本量:

24

Group:

4

Sample size:

干预措施:

老年组-低剂量

干预措施代码:

Intervention:

Elderly-Low dose

Intervention code:

组别:

5

样本量:

24

Group:

5

Sample size:

干预措施:

老年组-高剂量

干预措施代码:

Intervention:

Elderly-High dose

Intervention code:

组别:

6

样本量:

24

Group:

6

Sample size:

干预措施:

老年组-安慰剂

干预措施代码:

Intervention:

Elderly-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):

泰州中国医药城疫苗工程中心 

单位级别:

国家级医药高新区 

Institution
hospital:

China Medical City, the Vaccine Engineering Center  

Level of the institution:

National Medical high-tech Zone 

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

泰州市疾病预防控制中心 

单位级别:

地市级 

Institution
hospital:

Taizhou Center for Disease Control and Prevention  

Level of the institution:

Prefectural 

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

泰州市人民医院 

单位级别:

三级甲等 

Institution
hospital:

Taizhou People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

征集性局部反应发生率

指标类型:

主要指标 

Outcome:

Occurrence of solicited local reactions

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:

During the 14-day post injection

Measure method:

Observation and test

指标中文名:

征集性全身反应发生率

指标类型:

主要指标 

Outcome:

Occurrence of solicited systematic reactions

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:

During the 14-day post injection

Measure method:

Observation and test

指标中文名:

接种相关AE发生率

指标类型:

主要指标 

Outcome:

Occurrence of AE associated with vaccination

Type:

Primary indicator 

测量时间点:

初次接种后21天和加强接种后28天期间

测量方法:

观察、检测

Measure time point of outcome:

During the 21-day period after prime vaccination and the 28-day period after boost dose

Measure method:

Observation and test

指标中文名:

接种相关AE发生率

指标类型:

次要指标 

Outcome:

The proportion of subjects experiencing AE

Type:

Secondary indicator 

测量时间点:

初次接种后3、6和12个月期间

测量方法:

观察、检测

Measure time point of outcome:

Up to Month 3, 6 and 12

Measure method:

Observation and test

指标中文名:

血常规、生化和尿常规异常指标发生率

指标类型:

次要指标 

Outcome:

The proportion of of subjects experiencing abnormal markers of hematology, blood chemistry and urine analysis

Type:

Secondary indicator 

测量时间点:

初次接种后24小时、第7天和加强接种后第7天

测量方法:

检测

Measure time point of outcome:

At Hour 24 and Day 7 after prime vaccination and at Day 7 after boost dose

Measure method:

test

指标中文名:

Anti-S1 IgG抗体的几何平均滴度(GMT)

指标类型:

次要指标 

Outcome:

Geometric mean titer (GMT) of anti-S1 IgG antibody

Type:

Secondary indicator 

测量时间点:

初次接种后第7天、第21天和加强接种后第7天、第21天,初次接种后第3、6和12个月

测量方法:

检测

Measure time point of outcome:

At Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12

Measure method:

test

指标中文名:

Anti-RBD IgG抗体的几何平均滴度(GMT)

指标类型:

次要指标 

Outcome:

Geometric mean titer (GMT) of anti-RBD IgG antibody

Type:

Secondary indicator 

测量时间点:

初次接种后第7天、第21天和加强接种后第7天、第21天,初次接种后第3、6和12个月

测量方法:

检测

Measure time point of outcome:

At Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12

Measure method:

test

指标中文名:

SARS-CoV-2中和抗体GMT

指标类型:

次要指标 

Outcome:

GMT of SARS-CoV-2 neutralizing antibody

Type:

Secondary indicator 

测量时间点:

初次接种后第7天、第21天和加强接种后第7天、第21天,初次接种后第3、6和12个月

测量方法:

检测

Measure time point of outcome:

At Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12

Measure method:

test

指标中文名:

Anti-S1 IgG抗体滴度的增加倍数

指标类型:

次要指标 

Outcome:

Fold increase in antibody anti-S1 IgG antibody titers

Type:

Secondary indicator 

测量时间点:

初次接种后第7天、第21天和加强接种后第7天、第21天,初次接种后第3、6和12个月

测量方法:

检测

Measure time point of outcome:

At Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12

Measure method:

test

指标中文名:

Anti-RBD IgG抗体滴度的增加倍数

指标类型:

次要指标 

Outcome:

Fold increase in antibody anti-RBD IgG antibody titers

Type:

Secondary indicator 

测量时间点:

初次接种后第7天、第21天和加强接种后第7天、第21天,初次接种后第3、6和12个月

测量方法:

检测

Measure time point of outcome:

At Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12

Measure method:

test

指标中文名:

SARS-CoV-2中和抗体滴度增加倍数

指标类型:

次要指标 

Outcome:

Fold increase in SARS-CoV-2 neutralizing antibody titers

Type:

Secondary indicator 

测量时间点:

初次接种后第7天、第21天和加强接种后第7天、第21天,初次接种后第3、6和12个月

测量方法:

检测

Measure time point of outcome:

At Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12

Measure method:

test

指标中文名:

血清阳转率(SCR)

指标类型:

次要指标 

Outcome:

? Seroconversion rates (SCR)

Type:

Secondary indicator 

测量时间点:

初次接种后第7天、第21天和加强接种后第7天、第21天

测量方法:

检测

Measure time point of outcome:

At Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination

Measure method:

test

指标中文名:

SAE发生率

指标类型:

次要指标 

Outcome:

The proportion of subjects experiencing SAEs

Type:

Secondary indicator 

测量时间点:

初次接种后21天和加强接种后28天期间,以及初次接种后3、6和12个月期间

测量方法:

报告

Measure time point of outcome:

At Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12

Measure method:

Report

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:

结束

Completed

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:

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):

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

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-07-21
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