Today is 2023-01-29

Efficacy, safety and immunogenicity of a recombinant protein subunit vaccine (CHO cells) against COVID-19 in adults: an international multicenter, randomized, double-blind, placebo-controlled phase III study
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注册号:

Registration number:

ChiCTR2100050849 

最近更新日期:

Date of Last Refreshed on:

2022-05-08 

注册时间:

Date of Registration:

2021-09-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评价重组新型冠状病毒疫苗(CHO细胞)在18周岁及以上成年人中的保护效力、安全性和免疫原性的国际多中心、随机、双盲、安慰剂对照的III期临床试验 

Public title:

Efficacy, safety and immunogenicity of a recombinant protein subunit vaccine (CHO cells) against COVID-19 in adults: an international multicenter, randomized, double-blind, placebo-controlled phase III study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价重组新型冠状病毒疫苗(CHO细胞)在18周岁及以上成年人中的保护效力、安全性和免疫原性的国际多中心、随机、双盲、安慰剂对照的III期临床试验 

Scientific title:

Efficacy, safety and immunogenicity of a recombinant protein subunit vaccine (CHO cells) against COVID-19 in adults: an international multicenter, randomized, double-blind, placebo-controlled phase III 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:

魏文进 

研究负责人:

黄婷 

Applicant:

Wei Wenjin 

Study leader:

Huang Ting 

申请注册联系人电话:

Applicant telephone:

+86 18911290589 

研究负责人电话:

Study leader's telephone:

+86 13330993324 

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:

weiwenjin66@126.com 

研究负责人电子邮件:

Study leader's E-mail:

cocoht@163.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:

天津市北辰区淮河道12号 

研究负责人通讯地址:

四川省成都市武侯区中学路6号 

Applicant address:

38 Huaihe Road, Beichen District, Tianjin 

Study leader's address:

6 Zhongxue Road, Wuhou District, Chengdu, Sichuan 

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:

中逸安科生物技术股份有限公司 

Applicant's institution:

ZHONGYIANKE Biotech 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:

SC-0820212101 

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:

四川省疾病预防控制中心疫苗临床试验伦理委员会 

Name of the ethic committee:

Vaccine Clinical Trial Ethics Committee of Sichuan Center for Disease Control and Prevention 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-08-24 

伦理委员会联系人:

张骥 

Contact Name of the ethic committee:

Zhang Ji 

伦理委员会联系地址:

四川省成都市武侯区中学路6号 

Contact Address of the ethic committee:

6 Zhongxue Road, Wuhou District, Chengdu, Sichuan 

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:

四川省疾病预防控制中心 

Primary sponsor:

Sichuan Center for Disease Control and Prevention 

研究实施负责(组长)单位地址:

四川省成都市武侯区中学路6号 

Primary sponsor's address:

6 Zhongxue Road, Wuhou District, Chengdu, Sichuan 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

中逸安科生物技术股份有限公司

具体地址:

北辰区淮河道12号

Institution
hospital:

ZHONGYIANKE Biotech Co., Ltd

Address:

38 Huaihe Road, Beichen District

国家:

中国

省(直辖市):

辽宁

市(区县):

Country:

China

Province:

Liaoning

City:

单位(医院):

辽宁茂康源生物科技有限公司

具体地址:

东戴河新区A区昆山路西段5号

Institution
hospital:

Liaoning MAOKANGYUAN Biotech Co., Ltd

Address:

5 Kunshan Road West, Dongdaihe New District

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军军事科学院军事医学研究院

具体地址:

海淀区太平路27号

Institution
hospital:

Academy of Military Medical Sciences, Academy of Military Sciences

Address:

27 Taiping Road, Haidian 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:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

III期临床试验 

Study phase:

研究目的:

评价18周岁及以上成年人按0/28/56天免疫程序接种重组新型冠状病毒疫苗(CHO细胞)的保护效力、安全性和免疫原性。 

Objectives of Study:

To evaluate the efficacy, safety and immunogenicity of a recombinant protein subunit vaccine (CHO cells) against COVID-19 in adults aged 18 years and older following a 0/28/56-day regimen. 

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周岁以上的成年人,性别不限; 2. 能够理解并自愿签署知情同意书; 3. 经查问病史、体检和临床判定为健康或医学状况稳定。医学状况稳定定义为入组前3个月内不存在因疾病恶化导致治疗发生显著改变或住院; 4. 育龄期女性在接种前的妊娠试验结果呈阴性;且自愿同意从签署知情同意书开始至研究结束期间采取有效的避孕措施(有效的避孕措施包括:口服避孕药(不包括紧急避孕药)、注射或埋置避孕、缓释局部避孕药、激素贴剂、宫内节育器、绝育、禁欲、安全套(男性)、隔膜、宫颈帽等)。 

Inclusion criteria

1. Subjects aged 18 years and older; 2. Subjects capable of understanding and voluntarily signing the informed consent; 3. Subjects with general good health as judged by medical history and physical examination. General good health was defined as no significant change of treatment or hospitalization due to disease deterioration within 3 months prior to enrollment; 4. Women of childbearing age presented with a negative pregnancy test result prior to vaccination, and who voluntarily agree to take effective contraceptive measures (including: oral contraceptives (excluding emergency contraceptives), injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices, sterilization, abstinence, condoms (male), diaphragms, cervical caps, etc.) from the time of signing the informed consent until the end of the study. 

排除标准:

1. 有COVID-19病史,或筛选时SARS-CoV-2核酸和抗体检测其中之一阳性者(仅中国以外地区); 2. 入组前72小时内怀疑或确诊发热(腋温≥37.3℃/口温≥37.5℃),或入组当天腋下体温≥37.3℃/口温≥37.5℃; 3. 有严重急性呼吸综合征(SARS)、中东呼吸综合征(MERS)等人冠状病毒感染史或疾病史; 4. 任何确诊或疑似免疫抑制或免疫缺陷状态,已知的HIV感染史、无脾或功能性无脾; 5. 存在严重或不可控或需住院治疗的心血管疾病、糖尿病、神经系统疾病(如格林巴利综合征)、血液和淋巴系统疾病、免疫系统疾病、肝肾疾病、呼吸系统疾病(如活动性结核、肺纤维化)、代谢及骨骼等系统疾病,或恶性肿瘤; 6. 近3天内各种急性疾病或慢性疾病急性发作; 7. 有遗传性出血倾向,或凝血功能障碍,或有血栓或出血性病史,或需要持续使用抗凝药; 8. 既往有严重过敏史(包括药物和疫苗),或对试验疫苗的任何成分,包括铝制剂有严重过敏史,例如:过敏性休克、过敏性喉头水肿、过敏性紫癜、血小板减少性紫癜、局部过敏坏死反应(Arthus反应)、呼吸困难、血管神经性水肿等; 9. 有新型冠状病毒疫苗接种史(含附条件批准/紧急使用疫苗和试验疫苗); 10. 试验疫苗接种前3个月内注射过免疫球蛋白和/或其他血液制品; 11. 试验疫苗接种前28天内接受过减毒活疫苗,或接种前14天内接受过亚单位或灭活疫苗; 12. 曾参与或研究期间参加任何其他COVID-19预防性药物试验(注:如果因COVID-19住院,则允许参加COVID-19治疗试验,应尽快通知研究团队); 13. 过去6个月内长期使用(连续使用>14天)糖皮质激素(剂量≥20 mg/天,强的松或相当剂量)或其他免疫抑制剂,但以下情况允许入组:允许吸入或局部使用外用类固醇,或短期使用(疗程≤14天)口服类固醇; 14. 哺乳期女性; 15. 可疑或已知的严重酒精(酗酒)或药物依赖; 16. 可能影响试验参与情况的精神病史,精神病家族史; 17. 计划研究结束前从本地区永久搬迁或在研究访视期间长期(影响预定访视时间)离开本地; 18. 研究者认为不适宜参加试验的其他情况。 

Exclusion criteria:

1. History of COVID-19, or positive results for either SARS-CoV-2 nucleic acid and antibody tests at screening (outside China only); 2. Suspected or confirmed fever (axillary temperature >= 37.3 degrees/oral temperature >= 37.5 degrees) within 72 hours prior to or on the day of enrollment; 3. History of human coronavirus infection/diseases, such as severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS); 4. Any confirmed or suspected immunosuppression or immunodeficiency status, known history of HIV infection, absence or functional absence of spleen caused by any condition; 5. Presence of severe, uncontrollable or hospitalized cardiovascular diseases, diabetes, neurological diseases (e.g., Green-Barry syndrome), blood and lymphatic diseases, immune diseases, liver and kidney diseases, respiratory diseases (e.g., active tuberculosis, pulmonary fibrosis), metabolic and skeletal diseases, or malignant tumors; 6. Any acute diseases or acute attacks of chronic diseases 3 days prior to enrollment; 7. Genetic predisposition of bleeding, or history of coagulation disorders, thrombotic or bleeding disorders, or conditions that needs continuous anticoagulant usage; 8. History of severe allergy to drugs and vaccines, or to any component of the test vaccine (including the aluminum adjuvant), such as anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, Arthus reaction, dyspnea, angioneurotic edema, etc.; 9. Receipt of any SARS-COV-2 vaccine (including conditional approved/emergency use authorized vaccines or experimental vaccines); 10. Receipt of immunoglobulin and/or other blood products within 3 months prior to vaccination; 11. Receipt of live attenuated vaccine within 28 days prior to vaccination and other vaccines within 14 days prior to vaccination; 12. Previously or currently participation of any other COVID-19 prophylactic drug trials during the study (if subjects underwent hospitalization owning to COVID-19, participation in a treatment trial is permitted, but should notify the investigators immediately); 13. Long-term receipt (> 14 consecutive days) of glucocorticoid (reference value for dose: >= 20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 6 months, with exception of inhaled or topical corticosteroids, or short-term use (<= 14 consecutive days) of oral corticosteroids; 14. Lactating females; 15. Suspected or known history of severe alcohol (alcoholism) or drug dependence; 16. History or family history of psychiatric illness that may affect trial outcomes; 17. Planned permanent relocation from the study sites during the study or prolonged absence from the local area (affecting the scheduled visit time) during the study visits; 18. Other circumstances which the investigator considers inappropriate for participating in the trial. 

研究实施时间:

Study execute time:

From2021-09-02To  

征募观察对象时间:

Recruiting time:

From2021-09-02To  

干预措施:

Interventions:

组别:

疫苗组

样本量:

7000

Group:

Vaccine group

Sample size:

干预措施:

在0,28,56天各接种疫苗1剂,共3剂

干预措施代码:

Intervention:

Three doses of experimental vaccine at the schedule of day 0, 28, 56

Intervention code:

组别:

安慰剂组

样本量:

7000

Group:

Placebo group

Sample size:

干预措施:

在0,28,56天各接种安慰剂1剂,共3剂

干预措施代码:

Intervention:

Three doses of placebo at the schedule of day 0, 28, 56

Intervention code:

组别:

疫苗组(中国队列,免疫原性桥接)

样本量:

600

Group:

Vaccine(China cohort, for immunogenicity bridging)

Sample size:

干预措施:

在0,28,56天各接种疫苗1剂,共3剂

干预措施代码:

Intervention:

Three doses of experimental vaccine at the schedule of day 0, 28, 56

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

攀枝花 

Country:

China 

Province:

Sichuan 

City:

Panzhihua 

单位(医院):

攀枝花市疾病预防控制中心 

单位级别:

 

Institution
hospital:

Panzhihua Municipal Center for Disease Control and Prevention  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

预防病毒学确诊(RT-PCR阳性)的症状性COVID-19的保护效力(保护效力终点)

指标类型:

主要指标 

Outcome:

Protective efficacy of symptomatic, virologically confirmed (RT-PCR positive) COVID-19 cases (efficacy endpoint)

Type:

Primary indicator 

测量时间点:

全程免疫后28天

测量方法:

Measure time point of outcome:

28 days after full immunization

Measure method:

指标中文名:

AE发生率(安全性研究终点)

指标类型:

主要指标 

Outcome:

The incidence of adverse events (AE) (safety endpoint)

Type:

Primary indicator 

测量时间点:

首剂接种至全免后30天内

测量方法:

Measure time point of outcome:

From the first vaccination to 30 days after full Immunization

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血样

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:

尿样

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:

正在进行

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):

本试验国外研究部分采用分层区组随机化方法,按中心、年龄(18~59岁、≥60岁)分层,使用交互式网络应答随机系统(IWRS)完成受试者和试验用疫苗的随机分配。由随机化统计师采用SAS 9.4或以上版本的软件生成受试者随机表和疫苗随机表,并由系统工程师导入IWRS系统。参加本试验的各中心的研究人员在筛选成功受试者后,登录IWRS系统获取受试者随机号;研究者在疫苗接种前,登陆IWRS系统获取疫苗编号,并按照疫苗编号接种疫苗;若出现疫苗破损等情况,研究者可从IWRS系统获取新的疫苗编号,取用新的疫苗编号进行接种。国内研究部分为单臂设计,随机化与盲法不适用。

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

The trial used a block randomization method, stratified by center and age (18-59 years, >=60 years). The randomization of subjects and experimental vaccines was completed using an Interactive Web Response System (IWRS). Randomization tables were generated by an independent statistician using SAS statistical software.

盲法:

双盲

Blinding:

Double blind

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

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):

不准备共享原始数据 请阅读网页注册指南中关于 原始数据共享 的内容。

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

No scheduled individual participant data (IPD) sharing

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:

CRF和EDC系统

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

Case Record Form and Electronic Data Capture System

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-09-05
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