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The Impact of Timing of Vaccination on the Immune Reaction to Vaccine against SARS-CoV-2
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注册号:

Registration number:

ChiCTR2100045109 

最近更新日期:

Date of Last Refreshed on:

2021-05-17 

注册时间:

Date of Registration:

2021-04-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

接种时间对新冠疫苗免疫应答的影响 

Public title:

The Impact of Timing of Vaccination on the Immune Reaction to Vaccine against SARS-CoV-2  

注册题目简写:

IMPROVE-2 

English Acronym:

IMPROVE-2 

研究课题的正式科学名称:

接种时间对新冠疫苗免疫应答的影响 

Scientific title:

The Impact of Timing of Vaccination on the Immune Reaction to Vaccine against SARS-CoV-2  

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:

刘贻豪 

研究负责人:

彭穗 

Applicant:

Yihao Liu 

Study leader:

Sui Peng 

申请注册联系人电话:

Applicant telephone:

+86 13512767300 

研究负责人电话:

Study leader's telephone:

+86 13660652577 

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:

liuyih3@mail2.sysu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

pengsui@vip.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:

广东省广州市中山二路58号 

研究负责人通讯地址:

广东省广州市中山二路58号 

Applicant address:

58 Second Zhongshan Road, Guangzhou, Guangdong, China  

Study leader's address:

58 Second Zhongshan Road, Guangzhou, Guangdong, 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:

中山大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital, Sun Yat-Sen 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:

[2021]254 

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:

中山大学附属第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital, Sun Yat-Sen University  

伦理委员会批准日期:

Date of approved by ethic committee:

2021-04-06 

伦理委员会联系人:

林海峰 

Contact Name of the ethic committee:

Haifeng Lin 

伦理委员会联系地址:

广东省广州市中山二路58号 

Contact Address of the ethic committee:

58 Second Zhongshan Road, Guangzhou, Guangdong, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 20 87755766 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

linhf7@mail.sysu.edu.cn 

研究实施负责(组长)单位:

中山大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital, Sun Yat-Sen University  

研究实施负责(组长)单位地址:

广东省广州市中山二路58号 

Primary sponsor's address:

58 Second Zhongshan Road, Guangzhou, Guangdong, 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong Province

City:

Guangzhou

单位(医院):

中山大学附属第一医院

具体地址:

广东省广州市中山二路58号

Institution
hospital:

The First Affiliated Hospital, Sun Yat-Sen University

Address:

58 Second Zhongshan Road, Guangzhou, Guangdong, China

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:

其它 

Study phase:

N/A 

研究目的:

探讨上午或下午接种新冠疫苗对疫苗接种效果的影响。 

Objectives of Study:

To explore the immune response to an inactivated vaccine against SARS-CoV-2 vaccinating in the morning or afternoon 

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18岁-59岁。 

Inclusion criteria

aged 18-59 years old 

排除标准:

1) 对疫苗中任何成分过敏者,或既往发生过疫苗严重过敏反应者,如急性过敏反应、荨麻疹、皮肤湿疹、呼吸困难、血管神经性水肿或腹痛者; 2)发热者、患急性疾病、严重慢性疾病、处于慢性疾病的急性发病期者; 3)妊娠期妇女和哺乳期妇女,接种 3 个月内有生育计划; 4)有惊厥、癫痫、脑病或精神疾病史或家族史者;患未控制的癫痫和其他进行性神经系统疾病者,有格林巴利综合症病史者; 5)已被诊断为患有先天性或获得性免疫缺陷、HIV感染、淋巴瘤、白血病或其他自身免疫疾病; 6)已知或怀疑患有严重呼吸系统疾病、严重心血管疾病、肝肾疾病、恶性肿瘤者 7)有新冠病毒感染史者; 8)正在或者入组前一个月内服用可能影响免疫功能的药物,如免疫抑制剂或免疫增强剂或糖皮质激素(≥10mg强的松或其他等效糖皮质激素); 9)临床医师或接种工作人员认为不适合接种者。 

Exclusion criteria:

1. Those who are allergic to any component of the vaccine, and those who have history of severe allergic reactions to the vaccine, such as acute allergic reactions, urticaria, skin eczema, dyspnea, angioedema or abdominal pain; 2. Those with fever or those who suffer from acute diseases or severe chronic diseases in the acute stage of onset; 3. Pregnant women, lactating women, or having a pregnancy plan within 3 months; 4. Patients with a history or family history of convulsions, epilepsy, encephalopathy or mental illness; Patients with uncontrolled epilepsy and other progressive neurological diseases; Patients with a history of Guillain-Barré syndrome; 5. Those who have been diagnosed with congenital or acquired immunodeficiency HIV infected lymphoma leukemia or other autoimmune diseases; 6. Those who have severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases and malignant tumors; 7. A history of COVID-19 infection; 8. Patients who take medicine affecting the immune function, such as immunosuppressant agents or immunopotentiators or glucocorticoids (>=10mg prednisone or other equivalent glucocorticoids) within one month before enrollment; 9. Those who are considered unsuitable for vaccination by clinicians. 

研究实施时间:

Study execute time:

From2021-04-09To 2022-04-09 

征募观察对象时间:

Recruiting time:

From2021-04-09To 2022-05-09 

干预措施:

Interventions:

组别:

干预组

样本量:

236

Group:

Intervention group

Sample size:

干预措施:

上午接种疫苗

干预措施代码:

Intervention:

vaccinated in the morning

Intervention code:

组别:

对照组

样本量:

236

Group:

Control group

Sample size:

干预措施:

下午接种疫苗

干预措施代码:

Intervention:

vaccinated in the afternoon

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital, Sun Yat-Sen University  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

新冠病毒RBD特异性抗体水平

指标类型:

主要指标 

Outcome:

SARS-CoV-2 RBD specific antibody level

Type:

Primary indicator 

测量时间点:

基线和接种新冠疫苗第二剂后28天

测量方法:

化学发光免疫分析

Measure time point of outcome:

baseline and 28 days after the second dose of vaccination

Measure method:

Chemiluminescence analysis,CLIA

指标中文名:

不良反应

指标类型:

副作用指标 

Outcome:

Adverse reaction

Type:

Adverse events 

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

保存于中山一院生物样本库3年

Fate of sample:

Preservation 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):

受试者的随机化分组将在中山大学第一附属医院临床研究中心进行。采用分层区组随机的方法将受试者1:1随机分配到2个组。随机化分层因素是:年龄、性别。

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

The randomization will be carried out in the Clinical Trail Unit of the First Affiliated Hospital, Sun Yat-sen University.The subjects will be assigned into two groups at a 1:1 ratio by the method of stratified block randomization. Randomization stratified factors are age and gender.

盲法:

N/A

Blinding:

N/A

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

Yes

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):

试验完成后6个月内公开在Dryad https://datadryad.org/stash。

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

The IPD will be shared on Dryad(https://datadryad.org/stash) within 6 months after the end of the trail.

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:

所有临床资料和检测结果脱敏后将统一录到电子数据库,由专人负责管理。

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

All clinical data and laboratory examination will be uniformly recorded into the electronic database after desensitization. The database is managed by a special personnel.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-04-07
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