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A Phase II clinical trial to evaluate the immunogenicity and safety of different doses of a novel coronavirus pneumonia (COVID-19) mRNA vaccine in population aged 18-59 years
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注册号:

Registration number:

ChiCTR2100041855 

最近更新日期:

Date of Last Refreshed on:

2021-03-26 

注册时间:

Date of Registration:

2021-01-08 

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岁人群中接种的免疫原性和安全性的II期临床试验 

Public title:

A Phase II clinical trial to evaluate the immunogenicity and safety of different doses of a novel coronavirus pneumonia (COVID-19) mRNA vaccine in population aged 18-59 years 

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岁人群中接种的免疫原性和安全性的II期临床试验 

Scientific title:

A Phase II clinical trial to evaluate the immunogenicity and safety of different doses of a novel coronavirus pneumonia (COVID-19) mRNA vaccine in population aged 18-59 years 

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 0871-68312889 

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:

ynwsysy@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:

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

Study leader's address:

Third 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:

GXIRB2020-0066-1 

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:

广西伦理审查委员会 

Name of the ethic committee:

Guangxi IRB 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-12-15 

伦理委员会联系人:

唐振柱 

Contact Name of the ethic committee:

Zhenzhu Tang 

伦理委员会联系地址:

广西南宁市金洲路18号 

Contact Address of the ethic committee:

18 Jinzhou Road, Nanning, Guangxi Zhuang Autonomous Region, 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:

云南沃森生物技术股份有限公司 

Primary sponsor:

Yunnan Walvax Biotechnology Co., Ltd.  

研究实施负责(组长)单位地址:

云南省昆明市高新区云南省大学科技园二期A3栋3楼  

Primary sponsor's address:

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

丰台区东大街20号院

Institution
hospital:

Academy of military medicine, Academy of Military Sciences, PLA

Address:

20 Dong Avenue, Fengtai District

国家:

中国

省(直辖市):

江苏

市(区县):

苏州

Country:

China

Province:

Jiangsu

City:

Suzhou

单位(医院):

苏州艾博生物科技有限公司

具体地址:

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, 218 Xinghu Street, Suzhou Industrial Park

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:

II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岁健康人群中接种的免疫原性; 2. 评估不同剂量试验疫苗在18~59岁健康人群中接种的安全性。 

Objectives of Study:

1. To explore the immunogenicity of different doses of the investigational vaccine in population aged 18-59 years 2. To evaluate the safety of different doses of the investigational vaccine in population aged 18-59 years 

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.能提供受试者法定身份证明的18~59岁健康人,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.在入选本项研究前2周内已采用有效的避孕措施,妊娠试验阴性(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),并自愿同意在全程免疫后12个月内继续采用有效的避孕措施,如口服避孕药、注射或埋置避孕、缓释局部避孕药、激素贴剂、宫内节育器(IUD)、绝育、安全套(男性)、隔膜、宫颈帽等; 5.接种当天腋下体温<37.3℃。 

Inclusion criteria

1. A healthy person aged 18-59 who can provide the legal identification of the subjects, both male and female; 2. The subjects who knew the content of informed consent and the vaccination situation voluntarily signed the informed consent, and had the ability to use the thermometer, scale and fill in the diary card and contact card as required; 3. Subjects who can communicate well with researchers and understand and comply with the requirements of this study; four The subjects who had used effective contraceptive measures within 2 weeks before being enrolled in this study had negative pregnancy test (those with amenorrhea for at least 1 year or surgical sterilization with medical records could be exempted from pregnancy test), and voluntarily agreed to continue to use effective contraceptive measures within 12 months after full immunization, such as oral contraceptive, injection or embedded contraceptive, slow-release local contraceptive, hormone patch, intrauterine contraceptive IUD, sterilization, condom (male), diaphragm, cervical cap, etc; 5. Subjects with axillary temperature < 37.3 degrees C on the day of inoculation. 

排除标准:

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.处于月经期(第1-4天),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.有新型冠状病毒疫苗接种史者; 4.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; 5.乙肝(HBV)、丙肝(HCV)、梅毒或HIV病原学或血清学检测阳性者; 6.既往有SARS、MERS等人冠状病毒感染史或疾病史; 7.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; 8.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; 9.接种首剂疫苗前1个月内接种过任何疫苗; 10.不能耐受静脉穿刺者,有晕针晕血史者; 11.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; 12.已被诊断为患有先天性或获得性的免疫缺陷(例如:HIV感染); 13.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; 14.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); 15.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); 16.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; 17.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; 18.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; 19.研究者认为不适宜参加试验者。  

Exclusion criteria:

1. Those who do not meet the health standards in the comprehensive physical examination mainly include: (1) Patients with abnormal vital signs and clinical significance (awake pulse < 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) 2 times of the upper or lower limit of the normal reference range, and the clinical significance was judged by the researchers. 2. Women who are in menstrual period (day 1-4) or lactation period, or women who plan to get pregnant within 12 months from screening period to full immunization, men who plan to get pregnant with their partners, or those who plan to donate sperm and eggs; 3. subjects with a history of New Coronavirus vaccination; 4. there were cases of suspected cases of New Coronavirus pneumonia and suspected cases, and 1 months before signing the informed consent. There were people who had contact with COVID-19 cases and suspected cases, or those with high incidence or overseas travel experience; or those with COVID-19 infection or carriers: Serum Anti SARS-CoV-2 specific antibody positive or SARS-CoV-2 nucleic acid positive in throat swabs. 5. Patients with positive etiological or serological tests for hepatitis B (HBV), hepatitis C (HCV), syphilis or HIV; 6. Patients with previous history of SARS, mers and other coronavirus infection or diseases; 7. Patients with acute disease or acute attack of chronic disease within 2 weeks before the first dose of vaccine, or with fever (axillary temperature > 37.3 degrees C) or upper respiratory tract infection within 7 days before the first dose of vaccine; 8. Subjects with any history of severe adverse reactions of vaccine or drug, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema, etc.; 9. Subjects who had received any vaccine within one month before the first dose of vaccine; 10. Patients who can't tolerate venipuncture and have a history of needle and blood sickness; 11. Patients with hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis or bleeding, and abnormal detection results of coagulation function related indicators; 12. Patients who have been diagnosed with congenital or acquired immunodeficiency (e.g. HIV infection); 13. Subjects without spleen, functional spleen, and other important organs removed for any reason; 14. Patients with previous severe diseases with abnormal clinical manifestations that need to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bone and other system diseases and history of malignant tumor (excluding chronic disease with stable control, such as diabetes, hypertension, etc.); 15. Patients who had undergone surgery within 3 months before signing the informed consent, or planned to undergo surgery (including cosmetic surgery, dental surgery and oral surgery) during the trial period or within 3 months after the end of the trial; 16. Subjects who donated or lost blood (>= 450 ml) within 3 months before signing the informed consent, who received blood transfusion or used blood products, or planned to donate blood during the trial; 17. Any research or unregistered products (drugs, vaccines, biological products or devices) other than the research vaccine were used or planned to be used during the research period within 3 months before signing the informed consent form; eighteen For the subjects who received immunosuppressive therapy within 6 months before signing the informed consent, if they received systemic glucocorticoid therapy for a long time (for more than 2 consecutive weeks within 6 months, such as prednisone or similar drugs), but local medication (such as ointment, eye drops, inhalant or nasal spray) is allowed, the local medication shall not exceed the recommended dosage in the manual The patients who have any signs of systemic exposure; 19. The researchers considered it unsuitable to participate in the trial. 

研究实施时间:

Study execute time:

From2021-01-11To 2022-03-31 

征募观察对象时间:

Recruiting time:

From2021-01-11To 2021-02-28 

干预措施:

Interventions:

组别:

A

样本量:

120

Group:

A

Sample size:

干预措施:

新型冠状病毒 mRNA 疫苗 5ug/0.5ml

干预措施代码:

Intervention:

COVID-19 mRNA vaccine 5ug/0.5ml

Intervention code:

组别:

B

样本量:

120

Group:

B

Sample size:

干预措施:

新型冠状病毒 mRNA 疫苗 10ug/0.5ml

干预措施代码:

Intervention:

COVID-19 mRNA vaccine 10ug/0.5ml

Intervention code:

组别:

C

样本量:

120

Group:

C

Sample size:

干预措施:

新型冠状病毒 mRNA 疫苗15ug/0.5ml

干预措施代码:

Intervention:

COVID-19 mRNA vaccine 15ug/0.5ml

Intervention code:

组别:

D

样本量:

60

Group:

D

Sample size:

干预措施:

接种 安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广西壮族自治区 

市(区县):

永福 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region 

City:

Yongfu 

单位(医院):

永福县CDC 

单位级别:

疾病预防控制中心 

Institution
hospital:

Yongfu CDC  

Level of the institution:

CDC 

国家:

中国 

省(直辖市):

山西 

市(区县):

襄汾 

Country:

China 

Province:

Shanxi 

City:

Xiangfen 

单位(医院):

襄汾县CDC 

单位级别:

疾病预防控制中心 

Institution
hospital:

Xiangfen CDC  

Level of the institution:

CDC 

测量指标:

Outcomes:

指标中文名:

IgG抗体

指标类型:

主要指标 

Outcome:

IgG 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:

中和抗体

指标类型:

主要指标 

Outcome:

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:

细胞免疫

指标类型:

附加指标 

Outcome:

Cellular immunity

Type:

Additional 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:

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):

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:

因试验疫苗与安慰剂存在液体颜色的固有差别,试验难以做到双盲,故执行接种操作的研究者为非盲态,但其不可向其他参与试验的相关工作人员透露受试者分组信息。为确保受试者处于盲态,执行接种操作的窗口应尽可能保证一对一接种,避免受试者在该环节聚集,以规避受试者从试验用品颜色猜测组别从而导致安全性评价偏倚的风险。已授权进行疫苗接种的研究者不得再授权诸如受试者血样采集或安全性随访等可能导致盲态破坏的工作,以保证受试者安全性随访及免疫原性采血工作的盲态维持。

Blinding:

Blind method for subjects.

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

No

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 请阅读网页注册指南中关于 原始数据共享 的内容。

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

Manual upload

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:

 2021-01-08
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