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研究者撤销 评估不同技术路线新型冠状病毒疫苗序贯或同源加强免疫的安全性及有效性的前瞻性、多中心、随机对照、开放标签、盲终点评价临床试验
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注册号:

Registration number:

ChiCTR2200062207 

最近更新日期:

Date of Last Refreshed on:

2022-08-01 

注册时间:

Date of Registration:

2022-07-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

研究者撤销 评估不同技术路线新型冠状病毒疫苗序贯或同源加强免疫的安全性及有效性的前瞻性、多中心、随机对照、开放标签、盲终点评价临床试验 

Public title:

Canceled by the investigator Prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation clinical trial to assess the safety and efficacy of sequential or homologous booster immunization with COVID-19 vaccines by different technical routes 

注册题目简写:

NA 

English Acronym:

NA 

研究课题的正式科学名称:

不同技术路线新型关账疫苗疫苗序贯或同源加强免疫的安全性和有效性研究:一项开放标签随机对照试验  

Scientific title:

Safety and efficacy of sequential or homologous boosting of COVID-19 vaccines by different technical routes: an open-label randomized controlled trial 

研究课题代号(代码):

Study subject ID:

NA 

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:

NA 

申请注册联系人:

张勇 

研究负责人:

武桂珍 

Applicant:

Zhang Yong 

Study leader:

Wu Guizhen 

申请注册联系人电话:

Applicant telephone:

18612855285 

研究负责人电话:

Study leader's telephone:

13601201889 

申请注册联系人传真 :

Applicant Fax:

NA 

研究负责人传真:

Study leader's fax:

NA 

申请注册联系人电子邮件:

Applicant E-mail:

zhangyong8@ivdc.chinacdc.cn 

研究负责人电子邮件:

Study leader's E-mail:

wugz@ivdc.chinacdc.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

NA 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

NA 

申请注册联系人通讯地址:

北京市昌平区昌百路155号 

研究负责人通讯地址:

北京市昌平区昌百路155号 

Applicant address:

No. 155 Changbai Road, Changping District, Beijing 

Study leader's address:

No. 155 Changbai Road, Changping District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

102206 

研究负责人邮政编码:

Study leader's postcode:

102206 

申请人所在单位:

中国疾病预防控制中心病毒病预防控制所 

Applicant's institution:

National Institute for Viral Disease Control and Prevention,China CDC 

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:

IVDC2022第009号 

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:

中国疾病预防控制中心病毒病预防控制所伦理审查委员会 

Name of the ethic committee:

Ethical committee of National Institute for Viral Disease Control and Prevention, China CDC 

伦理委员会批准日期:

Date of approved by ethic committee:

2022-07-25 

伦理委员会联系人:

赵秀军 

Contact Name of the ethic committee:

Zhao Xiujun 

伦理委员会联系地址:

北京市昌平区昌百路155号 

Contact Address of the ethic committee:

No. 155 Changbai Road, Changping District, Beijing 

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-58900663 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

zhaoxj@ivdc.chincdc.cn 

研究实施负责(组长)单位:

中国疾病预防控制中心病毒病预防控制所 

Primary sponsor:

National Institute for Viral Disease Control and Prevention,China CDC 

研究实施负责(组长)单位地址:

北京市昌平区昌百路155号 

Primary sponsor's address:

No. 155 Changbai Road, Changping District, Beijing 

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

市(区县):

Country:

China

Province:

BeiJing

City:

单位(医院):

中国疾病预防控制中心病毒病预防控制所

具体地址:

北京市昌平区昌百路155号

Institution
hospital:

National Institute for Viral Disease Control and Prevention,China CDC

Address:

No. 155 Changbai Road, Changping District, Beijing

经费或物资来源:

政府资助 

Source(s) of funding:

Government Fundament 

研究疾病:

新型冠状病毒肺炎 

Target disease:

Corona Virus Disease 2019,COVID-19 

研究疾病代码:

NA 

Target disease code:

NA 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

比较不同生产单位生产的不同技术路线的新冠疫苗用于已完成2剂/3剂原型株新冠灭活疫苗基础免疫或加强免疫接种的受试者加强接种的有效性及安全性,为未来新冠疫苗免疫加强策略的制定提供依据 

Objectives of Study:

To compare the safety and immunogenicity of heterologous and homologous boost immunization against COVID-19 with different platforms SARS-CoV-2 vaccines produced by different manufacturers for subjects who have completed basic immunization (two dose) or booster immunization (three dose) with COVID-19 prototype inactivated vaccines, and to provide a basis for the development of future vaccination strategies for COVID-19 

药物成份或治疗方案详述:

NA 

Description for medicine or protocol of treatment in detail:

NA 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 年龄范围:18岁及以上人群; 2. 体温正常; 3.符合以下条件之一: (1)已完成新冠原型株灭活疫苗基础免疫(2针)后6-15个月; (2)已完成新冠原始株灭活疫苗加强免疫(3针)后6-9个月。 4.完成上述基础免疫或加强免疫所用疫苗为国药中生北京所和科兴中维2家生产单位所生产的原型株新冠灭活疫苗中的1种,且全程均接种同种疫苗。 5. 18岁以上女性受试者入组时没有怀孕(尿妊娠检测阴性)、未在哺乳期且在入组后的前7个月内无生育计划并采取有效避孕措施;在入选前2周内已采取有效的避孕措施; 6. 在整个研究随访期间,能够且愿意完成整个规定研究计划; 7. 本人有能力了解研究程序,经知情同意,自愿签署知情同意书,能够遵守临床研究方案的要求。 

Inclusion criteria

1.Age>=18 years. 2.Normal body temperature. 3.Meets one of the following conditions: (1)6-15 months after completion of basic (2 doses) immunization with inactivated vaccine of COVID-19 prototype strain. (2)6-9 months after completion of booster (3 doses) immunization with inactivated vaccine of COVID-19 prototype strain. 4.The vaccine administered previously was one of the CoronaVac inactivated SARS-CoV-2 vaccine (Sinovac Research and Development Co., Ltd.) or BBIBP-CorV (Sinopharm, China National Biotec Group Co.), and the same vaccine was administered throughout the whole vaccination. 5.Female subjects 18 years of age or older who are not pregnant (negative urine pregnancy test) at enrollment, are not lactating and have no childbearing plans and are using effective contraception within the first 7 months of enrollment, and have used effective contraception within 2 weeks prior to enrollment. 6.The subjects are capable and willing to complete the entire study plan throughout the study follow-up period. 7.The subjects can understand and comply with the study protocol, and sign the informed consent form voluntarily 

排除标准:

符合以下任一标准的受试者应从本研究中排除: 1. 患有严重慢性疾病或不能控制的疾病; 2. 未控制的神经性疾患、癫痫者; 3. 1周内接种过灭活疫苗或4周内接种过减毒疫苗者; 4. 患有先天性或获得性免疫缺陷者; 5. 严重过敏体质或明确存在对拟接种的疫苗组分过敏者; 6. 血小板减少症或凝血功能异常病史; 7. 恶性肿瘤患者等预期寿命<1年者; 8. 拒绝签署知情同意,或不能遵照方案要求完成随访; 9. 有新型冠状病毒感染史; 10. 妊娠或哺乳期女性,具有潜在生育能力但不能或不愿意在研究期间使用有效避孕措施的女性受试者; 11. 3个月内参加过其他临床试验或正在参加其他临床试验的受试者; 12. 研究者认为存在其他不适宜参与研究的情况 

Exclusion criteria:

1.Serious chronic disease that cannot be controlled. 2.Uncontrolled neurological disorders or epilepsy. 3.Vaccinated with any inactivated vaccine within 1 week or attenuated vaccine within 4 weeks. 4.Congenital or acquired immune deficiency. 5.Definite allergy to the component of the study vaccines. 6.Thrombocytopenia or abnormal coagulation. 7.Life expectancy <1 year. 8.Refuse to sign informed consent or fail to complete follow-up as required by the protocol. 9.Pregnant or lactating women, potentially fertile female subjects who are unable or unwilling to use effective contraception during the study period. 10.Virologically documented (PCR or serology) history of COVID-19. 11.Subjects who have participated in or are currently participating in other clinical trials within 3 months. 12.Other conditions that the investigator considers inappropriate to participate in this study 

研究实施时间:

Study execute time:

From2022-07-26To 2023-12-31 

征募观察对象时间:

Recruiting time:

From2022-07-28To 2022-08-31 

干预措施:

Interventions:

组别:

对照组

样本量:

152

Group:

Control group

Sample size:

干预措施:

注射疫苗-原型株灭活疫苗(国药中生北京所)和原型株灭活疫苗(科兴中维)

干预措施代码:

NA

Intervention:

inject vaccine

Intervention code:

组别:

试验组

样本量:

1064

Group:

Experimental group

Sample size:

干预措施:

注射疫苗-Omicron变异株灭活疫苗(国药中生北京所) Omicron变异株灭活疫苗(科兴中维) Omicron变异株灭活疫苗(国药中生武汉所) 重组蛋白疫苗(神州细胞二价苗) 重组蛋白疫苗(神州细胞四价苗) 重组蛋白疫苗(四川三叶草生物) 重组蛋白疫苗(国药中生研究院) 重组蛋白疫苗(上海泽润生物) 重组蛋白疫苗(成都威斯克生物) mRNA疫苗(康希诺生物) mRNA疫苗(斯微(上海)生物) mRNA疫苗(武汉瑞科吉生物) mRNA疫苗(石药集团) mRNA疫苗(艾博生物)

干预措施代码:

NA

Intervention:

inject vaccine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

市(区县):

朝阳区 

Country:

China 

Province:

BeiJing 

City:

Chaoyang 

单位(医院):

北京市朝阳区疾病预防控制中心 

单位级别:

市级 

Institution
hospital:

Beijing Chaoyang Center for Disease Prevention and Control  

Level of the institution:

Municipal 

国家:

中国 

省(直辖市):

山东 

市(区县):

青岛 

Country:

China 

Province:

Shan Dong 

City:

Qing Dao 

单位(医院):

青岛市疾病预防控制中心 

单位级别:

市级 

Institution
hospital:

Qingdao Municipal Center for Disease Control&Prevention  

Level of the institution:

Municipal 

国家:

中国 

省(直辖市):

福建 

市(区县):

 

Country:

China 

Province:

Fu Jian 

City:

 

单位(医院):

福建省疾病预防控制中心 

单位级别:

省级 

Institution
hospital:

Fujian Provincial Center for Disease Control and Prevention  

Level of the institution:

Provincial 

国家:

中国 

省(直辖市):

北京市 

市(区县):

延庆区 

Country:

China 

Province:

Beijing 

City:

Yanqing 

单位(医院):

北京市延庆区疾病预防控制中心 

单位级别:

市级 

Institution
hospital:

Beijing Yanqing District Center for Disease Control and Prevention  

Level of the institution:

Municipal 

测量指标:

Outcomes:

指标中文名:

SARS-CoV-2毒株(如Delta、Omicron BA.2、Omicron BA.4和Omicron BA.5)的中和抗体滴度和几何平均滴度(GMT)

指标类型:

主要指标 

Outcome:

Mean titer and Geometric mean titer (GMT) of neutralizing antibody against SARS-CoV-2(Delta , Omicron BA.2, BA.4, and Omicron BA.5 variant ) [Time Frame: 28 days after study vaccination]

Type:

Primary indicator 

测量时间点:

接种疫苗后28天

测量方法:

Measure time point of outcome:

28 days after study vaccination

Measure method:

指标中文名:

SARS-CoV-2变异株(Delta、Omicron BA.2、Omicron BA.4和Omicron BA.5)的中和抗体滴度

指标类型:

次要指标 

Outcome:

Mean titer of neutralizing antibody against SARS-CoV-2(Delta , Omicron BA.2, BA.4, and Omicron BA.5 variant )

Type:

Secondary indicator 

测量时间点:

疫苗接种后7天、14天、28天、3个月、6个月、12个月

测量方法:

Measure time point of outcome:

day 7, 14, 28 and month 3, 6, and 12 after study vaccination

Measure method:

指标中文名:

SRA-CoV-2变异株(Delta、Omicron BA.2、Omicron BA.4和Omicron BA.5)的几何平均滴度(GMT)

指标类型:

次要指标 

Outcome:

Geometric mean titer (GMT) of neutralizing antibody against SARS-CoV-2(Delta , Omicron BA.2, BA.4, and Omicron BA.5 variant )

Type:

Secondary indicator 

测量时间点:

疫苗接种后7天、14天、28天、3个月、6个月、12个月

测量方法:

Measure time point of outcome:

Day 7, 14, 28 and month 3, 6, and 12 after study vaccination

Measure method:

指标中文名:

特异性IFN-γ等细胞因子分泌水平(纳入队列为已完成新冠原始株灭活疫苗加强免疫(3针))

指标类型:

次要指标 

Outcome:

SARS-CoV-2-induced IFN-γ release(only for subjects who have completed booster immunization (three dose))

Type:

Secondary indicator 

测量时间点:

疫苗接种后7天、14天、28天、3个月、6个月、12个月

测量方法:

Measure time point of outcome:

Day 7, 14, 28 and month 3, 6, and 12 after study vaccination

Measure method:

指标中文名:

SARS-CoV-2感染率

指标类型:

次要指标 

Outcome:

Percentage of participants infected with SARS-Cov-2

Type:

Secondary indicator 

测量时间点:

疫苗接种后7天、14天、28天、3个月、6个月、12个月

测量方法:

Measure time point of outcome:

Day 7, 14, 28 and month 3, 6, and 12 after study vaccination

Measure method:

指标中文名:

重型和危重型COVID-19发生率

指标类型:

次要指标 

Outcome:

Percentage of participants who develop severe and critical COVID-19

Type:

Secondary indicator 

测量时间点:

疫苗接种后7天、14天、28天、3个月、6个月、12个月

测量方法:

Measure time point of outcome:

Day 7, 14, 28 and month 3, 6, and 12 after study vaccination

Measure method:

指标中文名:

COVID-19死亡率

指标类型:

次要指标 

Outcome:

Percentage of participants who dead from COVID-19

Type:

Secondary indicator 

测量时间点:

疫苗接种后7天、14天、28天、3个月、6个月、12个月

测量方法:

Measure time point of outcome:

Day 7, 14, 28 and month 3, 6, and 12 after study vaccination

Measure method:

指标中文名:

不良反应发生率

指标类型:

次要指标 

Outcome:

Percentage of participants with adverse drug reaction

Type:

Secondary indicator 

测量时间点:

疫苗接种后7天、14天、28天、3个月、6个月、12个月

测量方法:

Measure time point of outcome:

Day 7, 14, 28 and month 3, 6, and 12 after study vaccination

Measure method:

指标中文名:

不良事件及严重不良事件发生率

指标类型:

次要指标 

Outcome:

Percentage of participants with adverse events or serious adverse events

Type:

Secondary indicator 

测量时间点:

疫苗接种后7天、14天、28天、3个月、6个月、12个月

测量方法:

Measure time point of outcome:

Day 7, 14, 28 and month 3, 6, and 12 after study vaccination

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:

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):

统计学专家用随机区组的方法产生随机序列

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

The statistician uses the random block method to generate random sequences

盲法:

NA

Blinding:

NA

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否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):

暂不共享

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

Temporarily not Shared

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:

 2022-07-29
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