Today is 2021-01-18

Recombinant COVID-19 Vaccine (Sf9 cells) Phase II Clinical Trial
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注册号:

Registration number:

ChiCTR2000039994 

最近更新日期:

Date of Last Refreshed on:

2020-11-17 

注册时间:

Date of Registration:

2020-11-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

重组新型冠状病毒肺炎(COVID-19)疫苗(Sf9)II期临床试验研究 

Public title:

Recombinant COVID-19 Vaccine (Sf9 cells) Phase II Clinical Trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

在18周岁及以上健康成年和老年受试者中开展重组新型冠状病毒肺炎疫苗(Sf9细胞)的单中心、随机、双盲、安慰剂对照的Ⅱ期临床试验 

Scientific title:

A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase II Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 cells), in Healthy Adults 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:

王玮 

研究负责人:

朱凤才 

Applicant:

Wei Wang 

Study leader:

Fengcai Zhu 

申请注册联系人电话:

Applicant telephone:

+86 13679077022 

研究负责人电话:

Study leader's telephone:

+86 13951994867 

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:

weiwang@scu.edu.cn 

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:

中国四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

江苏省南京市江苏路172号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan University  

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-A065-01 

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:

Huiyuan Cai 

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:

+86 25-83759406 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

ec@jscdc.cn 

研究实施负责(组长)单位:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University  

研究实施负责(组长)单位地址:

成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

江苏

市(区县):

南京

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

江苏省疾病预防控制中心

具体地址:

江苏省南京市江苏路172号

Institution
hospital:

Jiangsu Provincial Center for Diseases Control and Prevention

Address:

172 Jiangsu Road

经费或物资来源:

自筹 

Source(s) of funding:

no funding 

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周岁及以上健康成年和老年受试者(年龄≥18岁且<60岁以及≥60岁且≤85岁)按不同免疫程序(0、21天和0、14、28天)接种不同剂量(20μg、40μg)重组新型冠状病毒肺炎疫苗(Sf9细胞)的免疫原性和安全性。 

Objectives of Study:

To evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in healthy adults and elderly (aged 18-60 and 60-85 years) with different immune procedure (0, 21 days or 0, 14, 28 days) 

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,并且能完成约6个月的研究随访。 4.腋下体温≤37.0℃。 5.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 18 years and above; 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 study follow-up period (about 6 months); 4. Axillary temperature <=37.0 degree C; 5. General good health as established by medical history and physical examination. 

排除标准:

1.2019新型冠状病毒抗体(IgG和IgM)筛查阳性。 2.已知的HIV感染史。 3.有惊厥、癫痫、脑病和精神病等病史或家族史者。 4.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。 5.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。 6.急性发热性疾病者及传染病者。 7.有SARS病史者。 8.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。 9.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。 10.先天或获得性的血管性水肿/神经性水肿。 11.接受试验疫苗前1年有患荨麻疹。 12.无脾或功能性无脾。 13.患血小板减少症或其他凝血障碍(可能造成肌肉注射禁忌)。 14.晕针者。 15.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)。 16.接受试验疫苗前4个月内接受过血液制品。 17.接受试验疫苗前1个月内接受过其他研究药物。 18.接受试验疫苗前1个月内接受过减毒活疫苗。 19.接受试验疫苗前14天内接受过亚单位或灭活疫苗。 20.正在接受抗结核治疗。 21.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. Positive serum IgM and IgG to the SARS-CoV-2; 2. History of HIV infection 3. Family history of seizure, epilepsy, brain or mental disease. 4. Participant that has an allergic history to any ingredient of vaccines; 5. oman who is pregnant, breast-feeding or positive in pregnancy test on day of enrollment, or is planning to be pregnant during the next 6 months; 6. Any acute fever disease or infections; 7. Have a medical history of SARS; 8. Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and not well-controlled; 9. Major chronic illness, such as asthma, diabetes, or thyroid disease, and not well-controlled; 10. Hereditary angioneurotic edema or acquired angioneurotic edema; 11. Urticaria in last one year; 12. Asplenia or functional asplenia; 13. Platelet disorder or other bleeding disorder may cause injection contraindication; 14. Faint at the sight of blood or needles; 15. Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months; 16. Prior administration of blood products in last 4 months; 17. Prior administration of other research medicines in last 1 month; 18. Prior administration of attenuated vaccine in last 1 month; 19. Prior administration of subunit vaccine or inactivated vaccine in last 14 days; 20. Being treated for tuberculosis; 21. Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives. 

研究实施时间:

Study execute time:

From2020-11-17To 2021-11-18 

征募观察对象时间:

Recruiting time:

From2020-11-17To 2020-12-18 

干预措施:

Interventions:

组别:

1

样本量:

100

Group:

1

Sample size:

干预措施:

18-59岁,试验疫苗 20μg 免疫程序 0,21天

干预措施代码:

Intervention:

18-59 years group, 20 ug vaccine injection on day 0, day 21

Intervention code:

组别:

2

样本量:

100

Group:

2

Sample size:

干预措施:

60-85岁,试验疫苗 20μg 免疫程序 0,21天

干预措施代码:

Intervention:

60-85 years groupm 20 ug vaccine injection on day 0, day 21

Intervention code:

组别:

3

样本量:

100

Group:

3

Sample size:

干预措施:

18-59岁,试验疫苗 40μg 免疫程序 0,21天

干预措施代码:

Intervention:

18-59 years group, 40 ug vaccine injection on day 0, day 21

Intervention code:

组别:

4

样本量:

100

Group:

4

Sample size:

干预措施:

60-85岁,试验疫苗 40μg 免疫程序 0,21天

干预措施代码:

Intervention:

60-85 years group, 40 ug vaccine injection on day 0, day 21

Intervention code:

组别:

5

样本量:

100

Group:

5

Sample size:

干预措施:

18-59岁,试验疫苗 20μg 免疫程序 0,14,28天

干预措施代码:

Intervention:

18-59 years group, 20 ug vaccine injection on day 0, day 14, day 28

Intervention code:

组别:

6

样本量:

100

Group:

6

Sample size:

干预措施:

60-85岁,试验疫苗 20μg 免疫程序 0,14,28天

干预措施代码:

Intervention:

60-85 years group, 20 ug vaccine injection on day 0, day 14, day 28

Intervention code:

组别:

7

样本量:

100

Group:

7

Sample size:

干预措施:

18-59岁,试验疫苗 40μg 免疫程序 0,14,28天

干预措施代码:

Intervention:

18-59 years group, 40 ug vaccine injection on day 0, day 14, day 28

Intervention code:

组别:

8

样本量:

100

Group:

8

Sample size:

干预措施:

60-85岁,试验疫苗 40μg 免疫程序 0,14,28天

干预措施代码:

Intervention:

60-85 years group, 40 ug vaccine injection on day 0, day 14, day 28

Intervention code:

组别:

9

样本量:

20

Group:

9

Sample size:

干预措施:

18-59岁,安慰剂0.5mL,免疫程序 0,21天

干预措施代码:

Intervention:

18-59 years. placebo 0.5 ml injection on day 0, day 21

Intervention code:

组别:

10

样本量:

20

Group:

10

Sample size:

干预措施:

60-85岁,安慰剂0.5mL,免疫程序 0,21天

干预措施代码:

Intervention:

60-85 years, placebo 0.5 ml injection on day 0, day 21

Intervention code:

组别:

11

样本量:

20

Group:

11

Sample size:

干预措施:

18-59岁,安慰剂1.0mL,免疫程序 0,21天

干预措施代码:

Intervention:

18-59 years group, placebo 1.0 ml injection on day 0, day 21

Intervention code:

组别:

12

样本量:

20

Group:

12

Sample size:

干预措施:

60-85岁,安慰剂1.0mL,免疫程序 0,21天

干预措施代码:

Intervention:

60-85 years group, placebo 1.0 ml injection on day 0, day 21

Intervention code:

组别:

13

样本量:

20

Group:

13

Sample size:

干预措施:

18-59岁,安慰剂0.5mL,免疫程序 0,14,28天

干预措施代码:

Intervention:

18-59 years, placebo 0.5 ml injection on day 0, day 14, day 28

Intervention code:

组别:

14

样本量:

20

Group:

14

Sample size:

干预措施:

60-85岁,安慰剂0.5mL,免疫程序 0,14,28天

干预措施代码:

Intervention:

60-85 years group, placebo 0.5 ml injection on day 0, day 14, day 28

Intervention code:

组别:

15

样本量:

20

Group:

15

Sample size:

干预措施:

18-59岁,安慰剂1.0mL,免疫程序 0,14,28天

干预措施代码:

Intervention:

18-59 years group, placebo 1.0 ml injection on day 0, day 14, day 28

Intervention code:

组别:

16

样本量:

20

Group:

16

Sample size:

干预措施:

60-85岁,安慰剂1.0mL,免疫程序 0,14,28天

干预措施代码:

Intervention:

60-85 years, placebo 1.0 ml injection on day 0, day 14, day 28

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):

南京 

Country:

China 

Province:

Jiangsu 

City:

nanjing 

单位(医院):

江苏省疾病预防控制中心 

单位级别:

省级疾病预防控制中心 

Institution
hospital:

Jiangsu Provincial Center for Diseases Control and Prevention  

Level of the institution:

Provincial Center for Diseases Control and Prevention  

测量指标:

Outcomes:

指标中文名:

各研究组末次免疫后1个月抗2019新型冠状病毒的S-RBD蛋白特异性抗体(ELISA法)的几何平均滴度(GMT)

指标类型:

主要指标 

Outcome:

GMT of anti-RBD specific antibody at Month 1 after boost vaccination.

Type:

Primary indicator 

测量时间点:

末次免疫后1个月

测量方法:

Measure time point of outcome:

Month 1 after boost vaccination

Measure method:

指标中文名:

各研究组每次免疫后0-7天不良反应(AR)发生率

指标类型:

主要指标 

Outcome:

Occurrence of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo

Type:

Primary indicator 

测量时间点:

每次免疫后0-7天

测量方法:

Measure time point of outcome:

within 7 days after each dose

Measure method:

指标中文名:

各研究组首次至末次免疫后1个月不良事件(AE)发生率

指标类型:

次要指标 

Outcome:

Occurrence of AE up to Month 1 after prime and boost vaccination.

Type:

Secondary indicator 

测量时间点:

首次至末次免疫后1个月

测量方法:

Measure time point of outcome:

Month 1 after prime and boost vaccination

Measure method:

指标中文名:

各研究组首次至末次免疫后1个月严重不良事件(SAE)发生率

指标类型:

次要指标 

Outcome:

The proportion of SAEs up to Month 1 after prime and boost vaccination

Type:

Secondary indicator 

测量时间点:

首次至末次免疫后1个月

测量方法:

Measure time point of outcome:

Month 1 after prime and boost vaccination

Measure method:

指标中文名:

各研究组首次至末次免疫后第6个月严重不良事件发生率

指标类型:

次要指标 

Outcome:

The proportion of SAEs in the 6th month after prime and boost vaccination

Type:

Secondary indicator 

测量时间点:

首次至末次免疫后第6个月

测量方法:

Measure time point of outcome:

the 6th month after prime and boost vaccination

Measure method:

指标中文名:

各研究组末次免疫后1个月抗2019新型冠状病毒特异性中和抗体(真病毒和假病毒中和试验法)的几何平均滴度(GMT)

指标类型:

次要指标 

Outcome:

GMT of SARS-CoV-2 neutralizing antibody at Month 1 after boost vaccination.

Type:

Secondary indicator 

测量时间点:

末次免疫后1个月

测量方法:

Measure time point of outcome:

Month 1 after boost vaccination

Measure method:

指标中文名:

各研究组末次免疫后第14天抗2019新型冠状病毒的S-RBD蛋白特异性抗体(ELISA法)的几何平均滴度(GMT)

指标类型:

次要指标 

Outcome:

GMT of anti-RBD specific antibody at Day 14 after boost vaccination.

Type:

Secondary indicator 

测量时间点:

末次免疫后第14天

测量方法:

Measure time point of outcome:

Day 14 after boost vaccination

Measure method:

指标中文名:

各研究组末次免疫后第14天、30天抗2019新型冠状病毒的S-RBD蛋白特异性抗体(ELISA法)的阳转率

指标类型:

次要指标 

Outcome:

seroconversion in anti-RBD specific antibody titers, at Day 14, Day 30 after boost vaccination.

Type:

Secondary indicator 

测量时间点:

末次免疫后第14天、30天

测量方法:

Measure time point of outcome:

Day 14 and Day 30 after boost vaccination

Measure method:

指标中文名:

各研究组末次免疫后第14天、30天抗2019新型冠状病毒的S-RBD蛋白特异性抗体(ELISA法)的几何平均增长倍数(GMI)

指标类型:

次要指标 

Outcome:

GMI of anti-RBD specific antibody at Day 14, Day 30 after boost vaccination.

Type:

Secondary indicator 

测量时间点:

末次免疫后第14天、30天

测量方法:

Measure time point of outcome:

Day 14 and Day 30 after boost vaccination

Measure method:

指标中文名:

各研究组末次免疫后第14天抗2019新型冠状病毒特异性中和抗体(真病毒和假病毒中和试验法)的几何平均滴度(GMT)

指标类型:

次要指标 

Outcome:

GMT of SARS-CoV-2 neutralizing antibody at Day 14 after boost vaccination.

Type:

Secondary indicator 

测量时间点:

末次免疫后第14天

测量方法:

Measure time point of outcome:

Day 14 after boost vaccination

Measure method:

指标中文名:

各研究组末次免疫后第14天、30天抗2019新型冠状病毒特异性中和抗体(真病毒和假病毒中和试验法)的阳转率

指标类型:

次要指标 

Outcome:

seroconversion in SARS-CoV-2 neutralizing antibody titers, at Day 14, Day 30 after boost vaccination.

Type:

Secondary indicator 

测量时间点:

末次免疫后第14天、30天

测量方法:

Measure time point of outcome:

Day 14 and Day 30 after boost vaccination

Measure method:

指标中文名:

各研究组末次免疫后第14天、30天抗2019新型冠状病毒特异性中和抗体(真病毒和假病毒中和试验法)的几何平均增长倍数(GMI)

指标类型:

次要指标 

Outcome:

GMFI of SARS-CoV-2 neutralizing antibody at Day 14, Day 30 after prime and boost vaccination.

Type:

Secondary indicator 

测量时间点:

末次免疫后第14天、30天

测量方法:

Measure time point of outcome:

Day 14 and Day 30 after boost vaccination

Measure method:

指标中文名:

抗2019新型冠状病毒的S-RBD蛋白特异性抗体(ELISA法)与特异性中和抗体(真病毒和假病毒中和试验法)的一致性分析。

指标类型:

附加指标 

Outcome:

The consistency analysis of the specific antibody (ELISA) and the specific neutralizing antibody (eucivirus and pseudovirus neutralization assays) against SARS-CoV-2 S-RBD protein

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

各研究组间抗2019新型冠状病毒的真病毒中和抗体几何平均滴度(GMT)和 S-RBD蛋白特异性抗体的几何平均滴度(GMT)比值。

指标类型:

附加指标 

Outcome:

The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody in each study groups

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

各研究组末次免疫后抗2019新型冠状病毒的S-RBD蛋白特异性抗体第6个月的持久性(GMT、阳转率、GMI)

指标类型:

附加指标 

Outcome:

The persistence (GMT,GMI,positive conversion rate) of specific antibodies against SARS-CoV-2 S-RBD protein at 6months after vaccination in each study group

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

2019新型冠状病毒的S-RBD蛋白所结合的IgG抗体的种类

指标类型:

附加指标 

Outcome:

Typing of IgG antibodies against the S-RBD protein of SARS-CoV-2 after immunization in each study group.

Type:

Additional 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

使用后保存 

说明

Fate of sample:

Preservation 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:

标本中文名:

咽拭子

组织:

Sample Name:

throat swab

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:

肛拭子

组织:

Sample Name:

anal swab

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 85 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):

本研究采用分层区组随机方法。由随机专员采用SAS软件以分层区组随机化方法产生随机编码,每个剂量组内试验苗与安慰剂对照苗按5:1的比例设置。

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

Stratified blocked randomization will be used to divide participants into experimental group and control group, which will be performed by statistic software SAS by a special personnel.

盲法:

本次临床试验实施过程中,应保持双盲状态,即研究者和受试者均不知道受试者接种的是试验疫苗还是安慰剂对照。 首次分析交由独立的统计方完成,统计方独立揭盲进行统计分析,并向申办方和研究者提交首次分析报告,首次分析报告中不得透露受试者个人的分组信息。现场将仍然维持双盲状态,整个临床试验开展期间不得泄露盲底。

Blinding:

Double blind

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

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):

Not stated

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

Not stated

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:

 2020-11-17
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