ChiCTR2200057278 版本V1.0 版本创建时间2022/3/6 17:27:42 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR2200057278 

最近更新时间:

Date of Last Refreshed on:

2022/3/6 17:27:17 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

不同新型冠状病毒疫苗加强免疫后的免疫原性研究 

Public title:

Immunogenicity Study on Booster Immunization of different COVID-19 vaccines 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

灭活疫苗、腺病毒载体新冠疫苗、重组蛋白新冠疫苗加强免疫后的免疫原性研究 

Scientific title:

Immunogenicity Study on Booster Immunization of Inactivated COVID-19 Vaccine, Ad5-vectored COVID-19 Vaccine and Recombinant Protein Subunit COVID-19 Vaccine  

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

侯利华 

研究负责人:

孙玉发 

Applicant:

Hou Lihua 

Study leader:

Sun Yufa 

申请注册联系人电话:

Applicant telephone:

010-66948565 

研究负责人电话:

Study leader's telephone:

010-63815273 

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:

houlihua@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

dafa20136725@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:

丰台区东大街20号 

研究负责人通讯地址:

北京市西城区府右街 

Applicant address:

No. 20 Dongdajie Street,Fengtai District, Beijing, China 

Study leader's address:

Fuyou Street,Xicheng District,Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100071 

研究负责人邮政编码:

Study leader's postcode:

100035 

申请人所在单位:

军事科学院军事医学研究院生物工程研究所 

Applicant's institution:

Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China  

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:

202201 

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:

中国人民解放军305医院医学伦理委员会 

Name of the ethic committee:

Ethic Committee of 305 Hospitsal of PLA 

伦理委员会批准日期:

Date of approved by ethic committee:

2022-01-06 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

中共中央办公厅警卫局保健处 

Primary sponsor:

Health Service Department of the Guard Bureau of the General Office of the Central Committee of the Communist Party of China 

研究实施负责(组长)单位地址:

北京市西城区府右街 

Primary sponsor's address:

Fuyou Street,Xicheng 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):

丰台区

Country:

China

Province:

Beijing

City:

Fengtai District

单位(医院):

军事科学院军事医学研究院生物工 程研究所

具体地址:

丰台区东大街20号

Institution
hospital:

Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

Address:

No. 20 Dongdajie Street,Fengtai District, Beijing, China

经费或物资来源:

国家科技部重点研发计划 

Source(s) of funding:

Ministry of Science and Technology of China 

研究疾病:

新型冠状病毒病 

Target disease:

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:

IV期临床试验 

Study phase:

研究目的:

评价18至59周岁健康成人加强接种不同新冠疫苗的免疫原性 

Objectives of Study:

Evaluation of immunogenecity of booster vaccination with different COVID-19 vaccines in healthy adults aged between 18 and 59 years. 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1. 18-59岁的健康受试者,至少6个月前接种过灭活新冠疫苗、Ad5载体疫苗或重组蛋白亚单位疫苗。 2.受试者可以提供知情同意书并签署知情同意书(ICF)。 3.受试者能够并愿意遵守本试验的要求,能够完成本研究的6个月随访。 4.身体健康,符合接种要求的人员 

Inclusion criteria

1.Healthy subjects aged 18-59 years, who have been vaccinated with the inactive COVID-19 vaccine, Ad5-Vectored Vaccine or the recombinant protein subunit vaccine at least 6 months ago. 2.The subject can provide with informed consent and sign informed consent form (ICF). 3.The subjects are able to and willing to comply with the requirements of this trial and could complete the 6-month follow-up of the study. 4.Individuals who are in good health condition and meet the requirements of vaccination 

排除标准:

1.有惊厥、癫痫、脑病、精神病的病史或家族史。 2.对疫苗的任何成分过敏,或曾对疫苗有过敏史或严重反应史。 3.尿妊娠试验阳性、怀孕或哺乳的妇女,或有六个月内怀孕计划的妇女。 4.患有急性发热性疾病和传染病。 5.有严重的慢性病或病情无法控制。 6.先天性或后天性血管性水肿/神经性水肿。 7.过去6个月内有免疫抑制治疗、抗过敏治疗、细胞毒治疗或吸入糖皮质激素(不包括用于过敏性鼻炎的糖皮质激素喷雾治疗和无皮炎的急性糖皮质激素治疗)。 8.在注射研究疫苗前4个月内接受过血液制品。 9.接受抗结核治疗。 10.由于各种医学、心理、社会或其他条件,无法遵守方案,或根据研究者的判断无法理解知情同意书。  

Exclusion criteria:

1.have the medical history or family history of convulsion, epilepsy, encephalopathy and psychosis. 2.be allergic to any component of the vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination. 3.women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months. 4.have acute febrile diseases and infectious diseases. 5.have severe chronic diseases or condition in progress cannot be controlled. 6.congenital or acquired angioedema / neuroedema. 7.have the history of immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy or inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and acute corticosteroid therapy without dermatitis) over the past 6 months. 8.have received blood products within 4 months before injection of investigational vaccines. 9.under anti-tuberculosis treatment. 10.not be able to follow the protocol, or not be able to understand the informed consent according to the investigator's judgment, due to various medical, psychological, social or other conditions. 

研究实施时间:

Study execute time:

From2021-12-20To 2022-07-31 

干预措施:

Interventions:

组别:

Ad5-nCoV-IM

样本量:

230

Group:

Ad5-nCoV-IM

Sample size:

干预措施:

肌肉注射腺病毒载体新冠疫苗

干预措施代码:

A

Intervention:

Intramuscular Ad5-nCoV

Intervention code:

组别:

Ad5-nCoV-IH

样本量:

230

Group:

Ad5-nCoV-IH

Sample size:

干预措施:

雾化吸入腺病毒载体新冠疫苗

干预措施代码:

B

Intervention:

Aerosol Ad5-nCoV

Intervention code:

组别:

ZF2001

样本量:

230

Group:

ZF2001

Sample size:

干预措施:

肌肉注射重组蛋白疫苗

干预措施代码:

C

Intervention:

Intramuscular ZF2001

Intervention code:

组别:

ICV

样本量:

230

Group:

ICV

Sample size:

干预措施:

肌肉注射灭活疫苗

干预措施代码:

D

Intervention:

Intramuscular inactivated vaccine

Intervention code:

组别:

Ad5-nCoN-IH-M

样本量:

80

Group:

Ad5-nCoN-IH-M

Sample size:

干预措施:

雾化吸入Ad5-nCoV

干预措施代码:

D

Intervention:

Aerosol Ad5-nCoV

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(区县):

西城区 

Country:

China 

Province:

Beijing 

City:

Xicheng District 

单位(医院):

中共中央办公厅警卫局保健处 

单位级别:

无 

Institution
hospital:

Health Service Department of the Guard Bureau of the General Office of the Central Committee of the Communist Party of China  

Level of the institution:

None 

国家:

中国 

省(直辖市):

北京市 

市(区县):

丰台区 

Country:

China 

Province:

Beijing 

City:

Fengtai District 

单位(医院):

军事科学院军事医学研究院生物工程研究所 

单位级别:

无 

Institution
hospital:

Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China  

Level of the institution:

None 

测量指标:

Outcomes:

指标中文名:

加强免疫后14天的抗SARS-CoV-2中和抗体

指标类型:

主要指标 

Outcome:

Neutralizing antibodies against SARS-CoV-2 virus on day 14 after the booster dose.

Type:

Primary indicator 

测量时间点:

加强免疫后14天

测量方法:

假病毒中和抗体检测

Measure time point of outcome:

Day 14

Measure method:

Pseudovirus NAb test

指标中文名:

加强免疫后14天的抗SARS-CoV-2 S蛋白结合抗体

指标类型:

主要指标 

Outcome:

Binding antibodies against SARS-CoV-2 Spike on day 14 after the booster dose.

Type:

Primary indicator 

测量时间点:

加强免疫后14天

测量方法:

ELISA

Measure time point of outcome:

Day 14

Measure method:

ELISA

指标中文名:

加强免疫后28天、3月、6月的抗SARS-CoV-2中和抗体

指标类型:

次要指标 

Outcome:

Neutralizing antibodies against SARS-CoV-2 virus on day 28, 3 month, 6 month after the booster dose.

Type:

Secondary indicator 

测量时间点:

加强免疫后28天、3月、6月

测量方法:

假病毒中和抗体检测

Measure time point of outcome:

Day 28, 3 month and 6 month

Measure method:

Pseudovirus NAb test

指标中文名:

加强免疫后7天、28天、3月、6月的抗SARS-CoV-2 S蛋白结合抗体

指标类型:

次要指标 

Outcome:

Binding antibodies against SARS-CoV-2 spike on day 7,day 28, 3 month, 6 month after the booster dose

Type:

Secondary indicator 

测量时间点:

加强免疫后7天、28天、3月、6月

测量方法:

ELISA

Measure time point of outcome:

Day 7,day 28, 3 month and 6 month

Measure method:

ELISA

指标中文名:

加强免疫后14天、28天的特异性T细胞免疫反应

指标类型:

次要指标 

Outcome:

Specific T cell responses on day 14 and 28 after the booster vaccination

Type:

Secondary indicator 

测量时间点:

加强免疫后14天、28天

测量方法:

IFN-r ELISPot

Measure time point of outcome:

Day 14 and Day 28

Measure method:

IFN-r ELISPot

指标中文名:

加强免疫后14天、28天的特异性记忆B细胞免疫反应

指标类型:

次要指标 

Outcome:

Specific memory B cell responses on day 14 and 28 after the booster vaccination

Type:

Secondary indicator 

测量时间点:

加强免疫后14天、28天

测量方法:

ELISpot

Measure time point of outcome:

Day 14 and Day 28

Measure method:

ELIspot

指标中文名:

加强免疫14天、28天后唾液中抗SARS-CoV-2 S蛋白SIgA抗体

指标类型:

附加指标 

Outcome:

sIgA antibodies against SARS-CoV-2 spike on day 14 and day 28after the booster dose

Type:

Additional indicator 

测量时间点:

加强免疫后14天、28天

测量方法:

ELISA

Measure time point of outcome:

Day 14 and Day 28

Measure method:

ELISA

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:

唾液

组织:

Sample Name:

Saliva

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 59 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):

本研究不采用随机方法。

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

Randomization is not used in this study

UTN(全球唯一识别码):

盲法:

非盲态试验

Blinding:

No blinding

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

0

Data collection Institution:

资料管理单位:

No

Data management Institution:

No

资料分析单位:

No

Data analysis Institution:

No

注册人:

Name on Registration:

 2022-03-06