Today is 2020-08-11

A Phase I clinical trial to evaluate the safety, tolerance and preliminary immunogenicity of different doses of a SARS-CoV-2 mRNA vaccine in population aged 18-59 years and 60 years and above
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注册号:

Registration number:

ChiCTR2000034112 

最近更新日期:

Date of Last Refreshed on:

2020-07-09 

注册时间:

Date of Registration:

2020-06-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评价不同剂量新型冠状病毒(COVID-19)mRNA疫苗在18~59岁、60岁及以上人群中接种的安全性、耐受性及初步免疫原性的I期临床试验 

Public title:

A Phase I clinical trial to evaluate the safety, tolerance and preliminary immunogenicity of different doses of a SARS-CoV-2 mRNA vaccine in population aged 18-59 years and 60 years and above 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价不同剂量新型冠状病毒mRNA疫苗在18~59岁、60岁及以上人群中接种的安全性、耐受性及初步免疫原性的I期临床试验 

Scientific title:

A Phase I clinical trial to evaluate the safety, tolerance and preliminary immunogenicity of different doses of a SARS-CoV-2 mRNA vaccine in population aged 18-59 years and 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:

杨舒媛 

研究负责人:

袁琳 

Applicant:

Shuyuan Yang 

Study leader:

Lin Yuan 

申请注册联系人电话:

Applicant telephone:

+86 18687832269 

研究负责人电话:

Study leader's telephone:

+86 13888316530 

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:

ynwsysy@walvax.com 

研究负责人电子邮件:

Study leader's E-mail:

ynwsyl@walvax.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:

云南省昆明市高新区云南省大学科技园二期A3栋3楼 

研究负责人通讯地址:

云南省昆明市高新区云南省大学科技园二期A3栋3楼 

Applicant address:

3rd Floor, Building A3, Phase 2, Yunnan University Science Park, High & New Technology Development Zone, Kunming, Yunnan, China 

Study leader's address:

3rd Floor, Building A3, Phase 2, Yunnan University Science Park, High & New Technology Development Zone, Kunming, Yunnan, 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:

云南沃森生物技术股份有限公司 

Applicant's institution:

Yunnan Walvax Biotechnology 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:

2020伦审第(18)号、GXIRB2020-0046 

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 Ethics Committee for Clinical Trials 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-06-19 

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:

浙江省杭州市下城区东新路848号 

Contact Address of the ethic committee:

848 Dongxin Road, Xiacheng District, Hangzhou, Zhejiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

树兰(杭州)医院、广西壮族自治区疾病预防控制中心 

Primary sponsor:

Shulan (Hangzhou) Hospital; Center for Disease Control and Prevention of Guangxi Zhuang Autonomous Region 

研究实施负责(组长)单位地址:

浙江省杭州市下城区东新路848号、广西南宁市金洲路18 号 

Primary sponsor's address:

848 Dongxin Road, Xiacheng District, Hangzhou, Zhejiang; 18 Jinzhou Road, Nanning, Guangxi Zhuang Autonomous Region, 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):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军军事科学院军事医学研究院

具体地址:

北京市丰台区东大街20号院

Institution
hospital:

Academy of Military Medicine, Academy of Military Science of the Chinese People's Liberation Army

Address:

20 Dongdajie, Fengtai District

国家:

中国

省(直辖市):

江苏省

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

苏州艾博生物科技有限公司

具体地址:

江苏省苏州市工业园区星湖街218号B1楼501室

Institution
hospital:

Suzhou Abogen Biosciences Co., Ltd.

Address:

Room 501, Building B1, No. 218 Xinghu Street, Suzhou Industrial Park, Jiangsu

国家:

中国

省(直辖市):

云南省

市(区县):

Country:

China

Province:

Yunnan

City:

单位(医院):

云南沃森生物技术股份有限公司

具体地址:

云南省昆明市高新区云南省国家大学科技园二期A3栋3楼

Institution
hospital:

Yunnan Walvax Biotechnology Co., Ltd.

Address:

3rd Floor, Building A3, Phase 2, Yunnan University Science Park, High & New Technology Development Zone, Kunming

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 

Target disease:

COVID-19 Pneumonia 

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:

1、评估不同剂量试验疫苗在18~59岁、60岁及以上人群中接种的安全性、耐受性及初步免疫原性。 2、探索推荐剂量试验疫苗的免疫持久性及针对S蛋白RBD段特异性细胞免疫应答情况。 

Objectives of Study:

1. To evaluate the safety, tolerance and preliminary immunogenicity of different doses of the investigational vaccine in population aged 18-59 years, and 60 years and above. 2. To explore the immune persistence of the investigational vaccine at recommended dose and the specific cellular immune response to the RBD of S protein. 

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:

受试者须符合所有下列入选标准: 1.能提供受试者法定身份证明的18~59岁、60岁及以上健康成年人,男女兼有; 2.受试者了解知情同意书内容及本次接种的疫苗情况,自愿签署知情同意书,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; 3.能够和研究者进行良好的沟通,并且理解和遵守本项研究的各项要求; 4.接种当天腋下体温≤37.3℃。 

Inclusion criteria

1. Healthy adults aged 18-59 years, or 60 years and above who can provide legal identity certificate of their own, both males and females are acceptable; 2. Subjects who understand the contents of the informed consent form and the background of the investigational vaccine, agree to sign the informed consent form voluntarily, and are able to use thermometer and scale, and may fill in the diary card and contact card as required; 3. Subjects who are able to have good communicate with investigator(s), understand and comply with the requirements of this study; 4. Axillary temperature≤ 37.3 ℃ on the day of vaccination. 

排除标准:

符合以下任一条排除标准的受试者不得入组: 1.全面体检不符合健康标准者,主要包括: (1)生命体征异常且有临床意义者(清醒状态脉搏<50次/分或>100次/分、收缩压≥140mmHg或舒张压≥90mmHg); (2)体重指数(BMI)<18 kg/m2或>30 kg/m2; (3)筛选窗口期内实验室检查值超出正常参考范围上限值或下限值的1.2倍,并且经研究者判断有临床意义者; 2.妊娠试验阳性的女性(处于月经期或闭经至少1年或有病历记录的外科绝育者可免除妊娠试验),或处于哺乳期女性,或从筛选期到全程免疫后12个月内计划怀孕的女性、伴侣计划怀孕的男性,或计划捐精捐卵者; 3.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,或咽拭子标本SARS-CoV-2核酸阳性; 4.乙肝(HBV)、丙肝(HCV)、梅毒或HIV病原学或血清学检测阳性者; 5.既往有SARS、MERS等人冠状病毒感染史或疾病史; 6.接种首剂疫苗前2周内发生急性疾病者或处于慢性病急性发作期,或接种首剂疫苗前7天内曾有发热(腋下体温>37.3℃)或上呼吸道感染的症状; 7.有任何疫苗或药物严重副反应史,例如:过敏、荨麻疹、皮肤湿疹、呼吸困难、血管神经性水肿等; 8.接种首剂疫苗前1个月内接种过任何疫苗; 9.不能耐受静脉穿刺者,有晕针晕血史者; 10.有遗传性出血倾向或凝血功能障碍,或有血栓或出血性病史,且凝血功能相关指标检测结果异常; 11.已被诊断为患有先天性或获得性的免疫缺陷(例如:HIV感染); 12.无脾、功能性无脾,以及由于任何原因手术摘除其他重要器官; 13.既往有临床表现异常、需排除的严重疾病,包括但不限于神经系统、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); 14.签署知情同意书前3个月内接受过外科手术者,或者计划在试验期间或试验结束后3个月内进行手术者(包括整容手术、牙科手术和口腔手术); 15.签署知情同意书前3个月内献血或失血(≥450 mL),接受输血或使用血制品者,或在试验期间计划献血者; 16.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; 17.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; 18.研究者认为不适宜参加试验者。  

Exclusion criteria:

Subjects who meet any of the following exclusion criteria may not be enrolled: 1. Subjects who do not meet the health standards as assessed through comprehensive physical examination, mainly including: (1) With abnormal and clinically significant vital signs (pulse rate under conscious state < 50 beats/min or > 100 beats/min, systolic blood pressure < 140 mmHg or diastolic blood pressure < 90 mmHg); (2) Body mass index (BMI) < 18 kg/m2 or > 30 kg/m2; (3) With laboratory values exceeding the upper or lower limit of normal reference range by 1.2 times during the screening time window and are adjudicated to be clinically significant by the investigators; 2. Women with positive pregnancy test (which may be exempt for women in menstrual phase or with amenorrhea for at least 1 year or who have medical records of surgical sterilization), or in lactation period, or who plan to conceive within 12 months from the screening period to completion of immunizations; males whose spouse plans to conceive; males or females who plan to donate sperm or eggs; 3. Subjects who have been diagnosed as confirmed or suspected cases of COVID-19 pneumonia, who have contact with confirmed or suspected cases of COVID-19 within 1 month before signing the informed consent form, or who have traveled abroad or in areas with high epidemic incidence, or who are infected with COVID-19 or are COVID-19 carriers: positive for serum anti-SARS-CoV-2 specific antibody, or positive for SARS-CoV-2 nucleic acid in throat swab specimens; 4. Positive results of etiological or serological tests for hepatitis B (HBV), hepatitis C (HCV), syphilis or HIV; 5. With prior history of human coronavirus infection or disease such as SARS and MERS; 6. Subjects who develop acute diseases or are in acute attack of chronic diseases within 2 weeks before the first dose of investigational vaccine, or who have fever (axillary temperature > 37.3 degree C) or upper respiratory tract infection within 7 days before the first dose of investigational vaccine; 7. With any history of serious side effects due to vaccines or drugs, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema, etc. 8. Have received any vaccine within 1 month before the first dose of investigational vaccine; 9. Subjects who cannot tolerate venipuncture, or have a history of needle or blood phobia; 10. With inherited bleeding tendency or coagulation dysfunction, or have a history of thrombosis or hemorrhagic disease, and have abnormal findings of coagulation function related indicators; 11. Have been diagnosed with congenital or acquired immunodeficiency (e.g., HIV infection); 12. Asplenia, functional asplenia, or have had surgical removal of other important organs for any reason; 13. With prior abnormal clinical manifestations and serious diseases that preclude the subjects from participating in the study, including but not limited to disorders of nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolic and skeletal diseases and history of malignant tumors (excluding patients with history of well-controlled chronic disease, such as diabetes, hypertension, etc.); 14. Have undergone surgery within 3 months before signing the informed consent form, or plan to undergo surgery (including cosmetic, dental and oral surgery) during the trial or within 3 months after the end of the trial; 15. Have donated blood or blood loss (> 450 mL) within 3 months before signing the informed consent form, recipients of blood transfusion or users of blood products, or plan to donate blood during the trial; 16. Have used any investigational or unlicensed products (drug, vaccine, biological product or device) other than the investigational vaccine within 3 months prior to signing the informed consent form, or plan to use them during the study; 17. Have received immunosuppressive therapy within 6 months before signing informed consent form, such as long-term systemic glucocorticoid therapy (such as prednisone or similar medications, for more than 2 consecutive weeks within 6 months), while local medications (such as ointment, eye drops, inhalant or nasal spray) are allowed, with dose not exceeding the recommended dose as indicated in package insert, and not to be applied in those who have signs of systemic exposure; 18. Subjects who are ineligible to participate in the trial as considered by the investigators. 

研究实施时间:

Study execute time:

From2020-06-25To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2020-06-25To 2021-10-31 

干预措施:

Interventions:

组别:

低剂量组

样本量:

56

Group:

Low dose group

Sample size:

干预措施:

接种对应剂量试验疫苗或安慰剂

干预措施代码:

Intervention:

Investigational vaccine or placebo of corresponding dose

Intervention code:

组别:

中剂量组

样本量:

56

Group:

Medium dose group

Sample size:

干预措施:

接种对应剂量试验疫苗或安慰剂

干预措施代码:

Intervention:

Investigational vaccine or placebo of corresponding dose

Intervention code:

组别:

高剂量组

样本量:

56

Group:

High dose group

Sample size:

干预措施:

接种对应剂量试验疫苗或安慰剂

干预措施代码:

Intervention:

Investigational vaccine or placebo of corresponding dose

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

树兰(杭州)医院 

单位级别:

三级甲等 

Institution
hospital:

Shulan (Hangzhou) Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广西壮族自治区 

市(区县):

 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region 

City:

 

单位(医院):

永福县疾病预防控制中心 

单位级别:

CDC 

Institution
hospital:

Yongfu County Center for Disease Control and Prevention  

Level of the institution:

CDC 

测量指标:

Outcomes:

指标中文名:

特异性IgG抗体

指标类型:

次要指标 

Outcome:

Specific IgG antibody

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中和抗体

指标类型:

次要指标 

Outcome:

Neutralizing antibody

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

细胞免疫

指标类型:

次要指标 

Outcome:

Cellular immunity

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:

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 80 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):

非盲随机化统计师应用SAS统计软件(9.4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):

SAS statistical software (version 9.4) is used by an unblinded randomization statistician to generate a randomized blinding code using block randomization.

盲法:

Not stated

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

手动上传

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

manual

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:

使用电子数据采集(EDC)系统对用于统计分析的必要数据进行采集。

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

Electronic Data Collection (EDC) system is employed to collect data necessary to statistical analysis.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-06-24
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