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A randomized, double-blind, placebo-controlled phase I clinical trial for evaluation of the safety and tolerability of recombinant novel coronavirus vaccines (CHO cells) in healthy people aged 60 years and above
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注册号:

Registration number:

ChiCTR2000035691 

最近更新日期:

Date of Last Refreshed on:

2020-08-16 

注册时间:

Date of Registration:

2020-08-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

随机、双盲、安慰剂对照评价重组新型冠状病毒疫苗(CHO细胞)在60周岁及以上健康人群中安全性和耐受性的Ⅰ期临床试验 

Public title:

A randomized, double-blind, placebo-controlled phase I clinical trial for evaluation of the safety and tolerability of recombinant novel coronavirus vaccines (CHO cells) in healthy people aged 60 years and above 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

随机、双盲、安慰剂对照评价重组新型冠状病毒疫苗(CHO细胞)在60周岁及以上健康人群中安全性和耐受性的Ⅰ期临床试验 

Scientific title:

A randomized, double-blind, placebo-controlled phase I clinical trial for evaluation of the safety and tolerability of recombinant novel coronavirus vaccines (CHO cells) in healthy people aged 60 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:

钟再新 

研究负责人:

李放军 

Applicant:

Zhong Zaixin 

Study leader:

Li Fangjun 

申请注册联系人电话:

Applicant telephone:

+86 18130032795 

研究负责人电话:

Study leader's telephone:

+86 13574109585 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+86 0731 84305903 

申请注册联系人电子邮件:

Applicant E-mail:

zhongzaixin@zhifeishengwu.com 

研究负责人电子邮件:

Study leader's E-mail:

646022285@qq.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:

安徽省合肥市蜀山区科学大道93号 

研究负责人通讯地址:

长沙市芙蓉中路一段450号 

Applicant address:

93 Science Avenue, Shushan District, Hefei, Anhui, China 

Study leader's address:

450 Section 1, Furong Middle Road, Changsha, Hu'nan, 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:

410005 

申请人所在单位:

安徽智飞龙科马生物制药有限公司 

Applicant's institution:

Anhui Zhifeilongkoma Biopharmaceutical 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:

湘疾控IRB2020020 

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:

湖南省疾病预防控制中心伦理委员会 

Name of the ethic committee:

Ethics Committee of Hu'nan Provincial Center for Disease Control and Prevention 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-08-11 

伦理委员会联系人:

张博夫 

Contact Name of the ethic committee:

Zhang Bofu 

伦理委员会联系地址:

长沙市芙蓉中路一段450号 

Contact Address of the ethic committee:

450 Section 1, Furong Middle Road, Changsha, Hu'nan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0731-84305972 

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:

湖南省疾病预防控制中心 

Primary sponsor:

Hunan Provincial Center for Disease Control and Prevention 

研究实施负责(组长)单位地址:

长沙市芙蓉中路一段450号 

Primary sponsor's address:

450 Section 1, Furong Middle Road, Changsha, Hu'nan, 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):

湖南省

市(区县):

长沙市

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

湖南省疾病预防控制中心

具体地址:

长沙市芙蓉中路一段450号

Institution
hospital:

Hunan Provincial Center for Disease Control and Prevention

Address:

450 Section 1, Furong Middle Road

经费或物资来源:

单位自筹 

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:

预防性研究 

Study type:

Prevention 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

主要目的: 评价不同剂量重组新型冠状病毒疫苗(CHO细胞)在60周岁及以上健康人群中应用的安全性和耐受性。 次要目的: 初步探索重组新型冠状病毒疫苗(CHO细胞)不同剂量的免疫原性和持久性。 

Objectives of Study:

main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccines (CHO cells) in healthy people aged 60 years and above. Secondary purpose: Preliminary exploration of the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells). 

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≥60周岁的完全民事行为能力人; 2)受试者自愿同意参加研究,并签署知情同意书,且能提供有效身份证明;理解和遵守试验方案要求;有能力了解(非文盲)研究程序,并能参加计划的随访; 3)腋下体温<37.3℃; 4)育龄女性受试者、男性受试者同意在研究进行期间采取有效避孕措施。 

Inclusion criteria

1) Persons with full capacity for civil conduct aged >=60 years; 2) Subjects voluntarily agree to participate in the research and sign an informed consent form, and can provide valid identification; understand and comply with the requirements of the trial protocol; have the ability to understand (non-illiterate) research procedures and participate in the planned follow-up; 3) Axillary body temperature <37.3 Degree C; 4) Female subjects and male subjects of childbearing age agree to take effective contraceptive measures during the study period. 

排除标准:

1)筛选前体格检查和实验室检查结果异常且经临床医生判定有临床意义,或筛选前收缩压≥160mmHg且/或舒张压≥100mmHg; 2)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;或既往有任何疫苗或药物使用后出现上述严重副反应史; 3)有SARS和SARS-CoV-2病史者(满足下列任一条:①既往有SARS和SARS-CoV-2感染或发病史;②本次SRAS-CoV-2流行期间,有与新冠确诊患者/疑似患者接触史); 4)首剂疫苗接种前24小时内曾服用退热药或止痛药; 5)在首剂疫苗接种前14天以内接种亚单位疫苗和/或灭活疫苗,在30天以内接种减毒活疫苗; 6)患有以下疾病者: ①急性(72小时内)发热性疾病者; ②在过去7天内患消化系统疾病(如,腹泻、腹痛、呕吐等); ③患有先天畸形或发育障碍、遗传缺陷,严重营养不良等; ④先天性或获得性的免疫缺陷或自身免疫疾病史或在6个月内接受免疫调节剂治疗,如激素;或单克隆抗体;或胸腺肽;或干扰素等;但允许局部用药(如软膏、滴眼液、吸入剂或鼻喷剂); ⑤已知被诊断为患有感染性疾病,例如:结核、病毒性肝炎现患者和/或人类免疫性缺陷病毒HIV抗体阳性或梅毒特异性抗体阳性者; ⑥神经性疾病或神经发育不良(例如,偏头痛,癫痫,中风,最近三年的癫痫发作,脑病,局灶性神经功能缺损,格林-巴利综合征,脑脊髓炎或横贯性脊髓炎;精神病病史或家族史; ⑦功能性无脾,以及任何原因导致的无脾或脾切除; ⑧有严重慢性疾病或病情处于进展期不能平稳控制,如糖尿病、甲状腺疾病; ⑨严重肝、肾疾病;当前需要日常药物治疗的呼吸道疾病(例如,慢性阻塞性肺疾病[COPD],哮喘)或最近5年内对呼吸道疾病加重(例如,哮喘加重)的任何治疗;患有严重的心血管疾病(例如充血性心力衰竭,心肌病,缺血性心脏病,心律失常、传导阻滞、心肌梗塞、肺心病)或心肌炎或心包炎的病史; ⑩有血小板减少症、任何凝血功能障碍或接受抗凝血剂治疗等; ?肿瘤患者; 7)3个月内曾经接受过血液或血液相关制品,包括免疫球蛋白;或在研究期间有计划使用; 8)已经怀孕(包括尿妊娠试验阳性),或处在哺乳期者; 9)3个月内使用了任何除研究产品之外的研究性或未注册产品(药物、疫苗、生物制品或器械),或计划在研究期间使用; 10)研究者认为,受试者存在任何疾病或状况可能会使受试者处于无法接受的风险;受试者无法满足方案要求;干扰对疫苗反应的评估的情况。 

Exclusion criteria:

1) The results of physical examination and laboratory examination before screening are abnormal and clinically significant as judged by clinicians, or systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg before screening; 2) A history of severe allergies to any component of the test vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction), dyspnea, blood vessels Neuroedema, etc.; or any previous history of serious side effects after the use of any vaccine or drug; 3) People with a history of SARS and SARS-CoV-2 (meet any of the following: ①Have a history of SARS and SARS-CoV-2 infection or onset; ②During this SRAS-CoV-2 epidemic, there are patients who have been diagnosed with the new crown/ Suspected patient contact history); 4) Have taken antipyretic or analgesic within 24 hours before the first dose of vaccination; 5) Inoculate subunit vaccine and/or inactivated vaccine within 14 days before the first dose of vaccine, and inoculate live attenuated vaccine within 30 days; 6) People suffering from the following diseases: ① Acute (within 72 hours) feverish illness; ②Suffering from digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days; ③Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; ④Congenital or acquired immunodeficiency or autoimmune disease history or receiving immunomodulator treatment within 6 months, such as hormones; or monoclonal antibodies; or thymosin; or interferon, etc.; but local medication (such as ointment, Eye drops, inhalation or nasal spray); ⑤ Known to have been diagnosed with infectious diseases, such as: tuberculosis, viral hepatitis and/or human immunodeficiency virus HIV antibody positive or syphilis specific antibody positive; ⑥ Neurological diseases or neurodevelopmental dysfunction (for example, migraine, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis; History of mental illness or family history; ⑦Functional asplenia, as well as any cause of aspleen or splenectomy; ⑧Severe chronic diseases or conditions that cannot be controlled smoothly in the advanced stage, such as diabetes and thyroid disease; ⑨Severe liver and kidney diseases; respiratory diseases that currently require daily drug treatment (for example, chronic obstructive pulmonary disease [COPD], asthma) or any treatment for exacerbation of respiratory diseases (for example, asthma exacerbation) in the last 5 years; suffering from severe History of cardiovascular disease (such as congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, pulmonary heart disease) or myocarditis or pericarditis; ⑩Have thrombocytopenia, any coagulation dysfunction or receive anticoagulant treatment, etc.; ?Tumor patients; 7) Have received blood or blood-related products, including immunoglobulin, within 3 months; or plan to use it during the research period; 8) Those who are already pregnant (including a positive urine pregnancy test), or are breastfeeding; 9) Any research or unregistered products (drugs, vaccines, biological products or devices) other than research products have been used within 3 months, or planned to be used during the research period; 10) The investigator believes that any disease or condition in the subject may put the subject at an unacceptable risk; the subject cannot meet the requirements of the protocol; it interferes with the assessment of the vaccine response. 

研究实施时间:

Study execute time:

From2020-08-20To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2020-08-20To 2021-12-31 

干预措施:

Interventions:

组别:

3组

样本量:

50

Group:

three Groups

Sample size:

干预措施:

高、低剂量加安慰剂对照

干预措施代码:

Intervention:

High and low dose groups, placebo control

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南省 

市(区县):

湘潭县 

Country:

China 

Province:

Hu'nan 

City:

Xiangtan County 

单位(医院):

湘潭县疾病预防控制中心 

单位级别:

CDC 

Institution
hospital:

Xiangtan County Center for Disease Control and Prevention  

Level of the institution:

CDC 

测量指标:

Outcomes:

指标中文名:

SARS-CoV-2中和抗体

指标类型:

主要指标 

Outcome:

SARS-CoV-2 neutralizing antibody

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

S蛋白结合抗体(IgG)

指标类型:

主要指标 

Outcome:

S protein binding antibody (IgG)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

RBD蛋白结合抗体(IgG)检测

指标类型:

主要指标 

Outcome:

RBD protein binding antibody (IgG) detection.

Type:

Primary 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:

标本中文名:

尿

组织:

Sample Name:

Pee

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 60 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):

本研究在各阶段内采用区组随机化的方法,按照4:1将受试者随机分配至试验疫苗组或安慰剂组。由随机化统计师采用SAS软件产生各剂量组内的受试者随机表。研究编号为01-50。试验现场研究者严格按照筛选合格的受试者的入组顺序依次分配研究编号,根据编号获取和接种试验用疫苗。 本试验准备备用疫苗50支,在各阶段内采用区组随机化的方法,按照4:1将备用疫苗编号分配至试验疫苗组或安慰剂组。由随机化统计师采用SAS统计软件产生备用疫苗随机分配表。当研究需要使用备用疫苗时,由研究者登陆备用疫苗获取系统获取相应编号的备用疫苗(研究者看到的只是研究编号,试验用疫苗和备用疫苗的真实组别事先导入系统,在试验全程中始终处于盲态;当备用苗数量不够时,可随时追加)。 随机化统计师制作疫苗编盲盲底,盲底一式两份,分为正本和副本,申办者专人和主要研究者各保存一份。

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

In this study, the method of block randomization was adopted in each stage, and subjects were randomly assigned to the experimental vaccine group or the placebo group according to 4:1. The randomized statistician uses SAS software to generate a random table of subjects in each dose group.

盲法:

本研究采用双盲设计,由随机化统计师与其他编盲人员进行疫苗编盲,即按照盲底将打印好的疫苗标签粘贴于每份疫苗指定位置。由随机化统计师督导疫苗编盲,指导编盲操作人员按照盲底进行贴签。完成编盲后,盲底应由随机化统计师封存。整个编盲过程须有文字记录。编盲人员不得参加本临床试验的其他相关工作,同时也不得向参加本临床试验工作的任何人员泄露盲底。

Blinding:

This study adopts a double-blind design. Randomization statisticians and other blind-editing personnel will perform vaccine blinding, that is, paste the printed vaccine label on the designated position of each vaccine according to the blind bottom. The randomization statistician supervises the blinding of vaccines, and guides the blinding operators to label according to the blinds. After completing the blind programming, the blind bottom should be sealed by the randomization statistician. There must be written records of the entire editing process.

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):

中国知网

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

https://www.cnki.net/

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

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-08-16
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