Today is 2021-07-30

Randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety and immunogenicity of mRNACOVID-19 vaccine in healthy susceptible populations aged 18 years and older people
download

注册号:

Registration number:

ChiCTR2100045984 

最近更新日期:

Date of Last Refreshed on:

2021-05-01 

注册时间:

Date of Registration:

2021-05-01 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

评价mRNA新型冠状病毒肺炎(COVID-19)疫苗在18岁及以上健康易感人群中接种的安全性及免疫原性的随机、双盲、安慰剂对照I期临床试验 

Public title:

Randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety and immunogenicity of mRNACOVID-19 vaccine in healthy susceptible populations aged 18 years and older people 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价mRNA新型冠状病毒肺炎(COVID-19)疫苗在18岁及以上健康易感人群中接种的安全性及免疫原性的随机、双盲、安慰剂对照I期临床试验 

Scientific title:

Randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety and immunogenicity of mRNACOVID-19 vaccine in healthy susceptible populations aged 18 years and older people 

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:

姚卫国 

研究负责人:

李兰娟,陈桂玲 

Applicant:

Weiguo Yao 

Study leader:

Lanjuan Li, Guiling Chen 

申请注册联系人电话:

Applicant telephone:

+86 18201871856 

研究负责人电话:

Study leader's telephone:

+86 18343113983 

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:

yaoweiguo@stemirna.com 

研究负责人电子邮件:

Study leader's E-mail:

chenguiling707@126.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:

上海市浦东新区川桥路1295号2幢402室 

研究负责人通讯地址:

浙江省杭州市东新路848号 

Applicant address:

Room 402, Building 2, 1295 Chuanqiao Road, Pudong New Area, Shanghai, China 

Study leader's address:

848 Dongxin Road, Hangzhou, Zhejiang, 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:

斯微(上海)生物科技有限公司 

Applicant's institution:

Stemirna Therapeutics 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:

2021伦审第(3)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:

树兰(杭州)医院临床试验伦理委员会 

Name of the ethic committee:

Shulan (Hangzhou) Hospital Clinical Trial Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-03-11 

伦理委员会联系人:

管文花 

Contact Name of the ethic committee:

Wenhua Guan 

伦理委员会联系地址:

中国-浙江省-杭州市-杭州市下城区东新路848号,树兰(杭州)医院1号楼门诊3楼03057房间  

Contact Address of the ethic committee:

Room 03057, 3rd Floor, Outpatient Clinic, Shulan (Hangzhou) Hospital, 848 Dongxin Road, Xiacheng District, Hangzhou, Zhejiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0571-56131318 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

yljdll@shulan.com 

研究实施负责(组长)单位:

树兰(杭州)医院 

Primary sponsor:

shulan (Hangzhou) Hospital 

研究实施负责(组长)单位地址:

浙江省杭州市东新路848号 

Primary sponsor's address:

848 Dongxin Road, Xiacheng District, Hangzhou, Zhejiang, 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):

浙江

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

树兰(杭州)医院

具体地址:

中国浙江省杭州市东新路848号

Institution
hospital:

8/5000 Shulan (Hangzhou) Hospital

Address:

848 Dongxin Road, Xiacheng District, Hangzhou

经费或物资来源:

上海市科学技术委员会 

Source(s) of funding:

Shanghai Municipal Science and Technology Commission 

研究疾病:

新冠 

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:

I期临床试验 

Study phase:

研究目的:

评价mRNA新型冠状病毒肺炎疫苗在18岁及以上健康易感人群中接种的安全性和免疫原性 

Objectives of Study:

To evaluate the safety and immunogenicity of mRNACOVID-19 vaccine in healthy susceptible populations aged 18 years and older people 

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岁及以上,能提供法定身份证明的中国人; 2. 根据病史和体检,经研究者判断确定为健康者,男女兼有; 3. 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,具有使用体温计、刻度尺和按要求填写日记卡和联系卡的能力。 

Inclusion criteria

1. Chinese aged 18 or above who can provide legal proof of identity; 2. According to the medical history and physical examination, the researcher determined that the patient was healthy, both male and female; 3. Having the ability to understand the study procedures, have informed consent, voluntarily signed informed consent, can comply with the requirements of the clinical study protocol, having the ability to use the thermometer, scale and fill in the diary card and contact card as required. 

排除标准:

1. 曾诊断新型冠状病毒肺炎病例、疑似病例,签署知情同意书前1个月内有和新冠病毒确诊病例及疑似病例接触史者,或有疫情高发区或境外旅行经历者;或新冠病毒感染者或携带者:血清抗SARS-CoV-2特异性抗体阳性,或鼻咽拭子标本SARS-CoV-2核酸阳性; 2. 乙肝表面抗原定性、丙型肝炎病毒核心抗原、丙型肝炎病毒抗体、梅毒螺旋体特异性抗体、人免疫缺陷病毒抗体检测阳性者; 3. 有SARS/MERS病毒感染史(自报,现场问询); 4. 接种过其他新型冠状病毒疫苗; 5. 对乙酰氨基酚有过敏史者; 6. 女性血妊娠试验阳性或怀孕、哺乳期者,或在14个月内有怀孕计划的女性、伴侣有怀孕计划的男性; 7. 有过敏、惊厥、癫痫、脑病和精神等病史或家族史者; 8. 既往有任何药品或疫苗接种过敏史(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)或对新型冠状病毒疫苗已知成份过敏; 9. 有医院诊断的血小板减少或其他凝血障碍病史; 10. 有医院诊断的已知免疫学功能损伤或低下者; 11. 3个月内接受过全血、血浆和免疫球蛋白治疗者,3个月内献血或失血(≥450ml),或试验期间计划献血者; 12. 临床研究接种前检测血生化、血常规、尿常规相关指标异常有临床意义者; 13. 接种前14天内出现发热(腋温≥37.3℃)、干咳、乏力、鼻塞、流涕、咽痛、肌痛、腹泻、呼吸急促、呼吸困难症状者; 14. 接种前1个月内接种过减毒活疫苗,接种前14天内接受过其他疫苗; 15. 接种时腋下体温≥37.3℃者; 16. 签署知情同意书前6个月内接受免疫抑制剂治疗,如长期应用全身糖皮质激素治疗(6个月内连续2周以上应用了全身性糖皮质激素治疗,例如强的松或同类药物),但允许局部用药(如软膏、滴眼液、吸入剂或鼻喷剂),局部用药不得超过说明书中推荐的剂量或有任何全身性暴露体征者; 17. 神经系统、心血管系统、血液和淋巴系统、免疫系统、肾脏、肝脏、胃肠道、呼吸系统、代谢及骨骼等系统疾病及恶性肿瘤病史者(不包括控制稳定的慢性病史,如糖尿病、高血压等); 18. 研究者认为与预防接种有关的禁忌症。 19. 签署知情同意书前3个月内使用了任何除本研究疫苗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。 

Exclusion criteria:

1. Have been diagnosed with a COVID-19 case or suspected case, had contact with a confirmed or suspected case of Novel Coronavirus within one month before signing the informed consent, or have traveled to areas with high epidemic incidence or abroad; Or novel coronavirus infection or carrier: serum anti-SARS-CoV-2 specific antibody positive, or nasopharyngeal swab specimens SARS-CoV-2 nucleic acid positive; 2. Patients with HBV surface antigen characterization, hepatitis C virus core antigen, hepatitis C virus antibody, treponema pallidum specific antibody, human immunodeficiency virus antibody detection positive; 3. Have a history of SARS/MERS virus infection (self-report, on-site inquiry); 4. Have received other Novel Coronavirus vaccines; 5. Have a history of allergy to acetaminophen; 6. Female with positive blood pregnancy test, pregnant or lactating, or female who plans to become pregnant within 14 months, or male whose partner plans to become pregnant; 7. Patients with a history or family history of allergies, convulsions, epilepsy, encephalopathy and mental illness; 8. Previous allergic history of any drug or vaccine vaccination (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema, or abdominal pain) or allergy to known components of Novel Coronavirus vaccine; 9. A history of thrombocytopenia or other coagulation disorders diagnosed in the hospital; 10. Patients with known immunological impairment or low function diagnosed by hospital; 11. Patients who have received whole blood, plasma and immunoglobulin treatment within 3 months, who have donated or lost blood within 3 months (≥450ml), or who plan to donate blood during the trial; 12. In clinical studies, abnormal blood biochemical, blood routine and urine routine indexes were detected before inoculation, which had clinical significance; 13. Patients with fever (armpit temperature ≥37.3℃), dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, tachypnea, dyspnea within 14 days before inoculation; 14. Have received live attenuated vaccine within one month prior to vaccination and other vaccines within 14 days prior to vaccination; 15. Armpit temperature >=37.3 degree C at the time of inoculation; 16. Immunosuppressive therapy within 6 months prior to signing the informed consent, such as long-term systemic glucocorticoid therapy (systemic glucocorticoid therapy, such as prednisone or similar drugs, for more than 2 consecutive weeks within 6 months), but topical medication (such as ointment, eye drops, inhalants or nasal sprays) is allowed. Topical medication should not exceed the recommended dose in the instructions or there are any signs of systemic exposure; 17. Patients with a history of diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolic system and skeletal system or malignant tumors (excluding chronic history with stable control, such as diabetes, hypertension, etc.); 18. Contradictions considered by the investigator to be associated with vaccination. 19. Any investigational or unregistered product (drug, vaccine, biological product or device) other than the study vaccine was used or planned to be used during the study period during the 3 months prior to signing the informed consent. 

研究实施时间:

Study execute time:

From2021-03-25To 2022-05-25 

征募观察对象时间:

Recruiting time:

From2021-03-26To 2021-07-23 

干预措施:

Interventions:

组别:

低剂量成年组

样本量:

30

Group:

Low dose adult group

Sample size:

干预措施:

mRNA新型冠状病毒肺炎疫苗/安慰剂

干预措施代码:

Intervention:

mRNA COVID-19 vaccine/Placebo

Intervention code:

组别:

中剂量成年组

样本量:

30

Group:

Medium-dose adult group

Sample size:

干预措施:

mRNA新型冠状病毒肺炎疫苗/安慰剂

干预措施代码:

Intervention:

mRNA COVID-19 vaccine/Placebo

Intervention code:

组别:

次高剂量成年组

样本量:

30

Group:

Secondary high-dose adult group

Sample size:

干预措施:

mRNA新型冠状病毒肺炎疫苗/安慰剂

干预措施代码:

Intervention:

mRNA COVID-19 vaccine/Placebo

Intervention code:

组别:

高剂量成年组

样本量:

30

Group:

High dose adult group

Sample size:

干预措施:

mRNA新型冠状病毒肺炎疫苗/安慰剂

干预措施代码:

Intervention:

mRNA COVID-19 vaccine/Placebo

Intervention code:

组别:

低剂量老年组

样本量:

30

Group:

Low dose older group

Sample size:

干预措施:

mRNA新型冠状病毒肺炎疫苗/安慰剂

干预措施代码:

Intervention:

mRNA COVID-19 vaccine/Placebo

Intervention code:

组别:

中剂量老年组

样本量:

30

Group:

Medium-dose older group

Sample size:

干预措施:

mRNA新型冠状病毒肺炎疫苗/安慰剂

干预措施代码:

Intervention:

mRNA COVID-19 vaccine/Placebo

Intervention code:

组别:

次高剂量老年组

样本量:

30

Group:

Secondary high-dose older group

Sample size:

干预措施:

mRNA新型冠状病毒肺炎疫苗/安慰剂

干预措施代码:

Intervention:

mRNA COVID-19 vaccine/Placebo

Intervention code:

组别:

高剂量成年组

样本量:

30

Group:

High dose older group

Sample size:

干预措施:

mRNA新型冠状病毒肺炎疫苗/安慰剂

干预措施代码:

Intervention:

mRNA COVID-19 vaccine/Placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

安全性指标

指标类型:

主要指标 

Outcome:

Security Index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫原性指标

指标类型:

次要指标 

Outcome:

immunogenicity index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性指标

指标类型:

主要指标 

Outcome:

Security Index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫原性指标

指标类型:

次要指标 

Outcome:

Immunogenicity indicators

Type:

Secondary 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:

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

尿

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后保存 

说明

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 ~ 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):

由随机化统计师应用SAS统计软件(9.4或以上版本),采用区组随机化方法产生随机化盲底。

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

Randomized blind bottom was generated by block randomization using SAS statistical software (version 9.4 or above) by randomized statisticians.

盲法:

Not stated

Blinding:

Not stated

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):

不适用

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

NA

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:

不适用

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

NA

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2021-05-01
return list