ChiCTR2100049530 版本V1.4 版本创建时间2022/03/04 19:48:50 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100049530 

最近更新日期：

Date of Last Refreshed on：

 2022-03-04 17:55:50 

注册时间：

Date of Registration：

 2021-08-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

重组新型冠状病毒疫苗（黑猩猩腺病毒载体）II期临床试验

Public title：

A Phase II Clinical Trial of the Recombinant SARS-CoV-2 Vaccine (Chimpanzee Adenoviral Vector)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价重组新型冠状病毒疫苗（黑猩猩腺病毒载体）（ChAdTS-S）在18~59岁、60岁及以上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 the Recombinant SARS-CoV-2 Vaccine (Chimpanzee Adenoviral Vector, ChAdTS-S) in Participants Aged 18 to 59 Years as well as 60 Years and Older

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：

Yang Shuyuan 

Study leader：

Yuan Lin 

申请注册联系人电话：

Applicant telephone：

 +86 18687832269

研究负责人电话：

Study leader's
telephone：

+86 871 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

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

Applicant address：

Yunnan University Science and Technology Park, High-tech Zone, Kunming,Yunnan

Study leader's address：

Yunnan University Science and Technology Park, High-tech Zone, Kunming,Yunnan

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：

Walvax Biotechnology Co., Ltd.

研究负责人所在单位：

云南省疾病预防控制中心

Affiliation of the Leader：

Yunnan Provincial Center for Disease Control and Prevention

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：

 批件2021-4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：

云南省疾病预防控制中心疫苗临床试验伦理委员会

Name of the ethic committee：

Ethics Committee of Vaccine Clinical Trials of Yunnan Provincial Center for Disease Control and Prevention

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-07-16 00:00:00

伦理委员会联系人：

高莉

Contact Name of the ethic committee：

Gao Li

伦理委员会联系地址：

云南省昆明市西山区东寺街158号

Contact Address of the ethic committee：

158 Dongsi Street, Xishan District, Kunming, Yunnan, 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：

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

Primary sponsor's address：

Yunnan University Science and Technology Park, High-tech Zone, Kunming,Yunnan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

云南

市(区县)：

昆明

Country：

China

Province：

Yunnan

City：

Kunming

单位(医院)：

云南沃森生物技术股份有限公司

具体地址：

高新区云南省大学科技园

Institution
hospital：

Walvax Biotechnology Co., Ltd.

Address：

Yunnan University Science and Technology Park, High-tech Zone

经费或物资来源：

申办者自筹

Source(s) of funding：

Self-funded

研究疾病：

新型冠状病毒肺炎(COVID-19)  

Target disease：

Corona Virus Disease 2019 (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：

2

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1.评估试验疫苗在18~59岁、60岁及以上健康人群中接种的免疫原性； 2.评估试验疫苗在18~59岁、60岁及以上健康人群中接种的安全性。  

Objectives of Study：

1.To evaluate the immunogenicity of the investigational vaccine in healthy participants aged 18-59 years as well as 60 years and older; 2.To evaluate the safety of the investigational vaccine in healthy participants aged 18-59 years as well as 60 years and older.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

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，具备使用体温计、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（仅限育龄女性，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个月内继续采用至少1种有效的避孕措施[有效的避孕措施包括：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、禁欲、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. Healthy subjects aged 18-59 years as well as 60 years and above who are capable of providing legal identities. Both males and females should be included;
2. The subjects shall fully understand the content of the informed consent form and the study procedure of this clinical trial. The subjects shall voluntarily sign the informed consent form. The subjects shall be capable of using the thermometer and scale, as well as filling in the Diary Card/Contact Card as required;
3. The subjects shall be able to communicate well with the investigators, as well as understand and comply with the requirements of this study;
4. For female subjects of childbearing potential, effective contraception should be used within 2 weeks prior to participation in this study and the pregnancy test is required to be negative (those with amenorrhea of at least 1 year or surgical sterilization verified by medical records could be exempted from the pregnancy test). Participants should voluntarily agree to continue using at least one effective method of contraception for 12 months after complete series (effective methods include oral contraceptives, injectable or implantable contraceptives, sustained-release topical contraceptives, hormonal patches, intrauterine device, sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.);
5. Axillary temperature <37.3℃ on the day of administration.

排除标准：

首剂接种排除标准：
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（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.接种当天处于月经期（月经来潮的第1天至第4天内）或处于哺乳期的女性，或从筛选期到全程免疫后12个月内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，或有疫情高中风险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 IgG、IgM特异性抗体阳性，或咽拭子标本SARS-CoV-2核酸阳性；
5.乙肝表面抗原定性、丙型肝炎病毒抗体、梅毒螺旋体特异性抗体、人类免疫缺陷病毒抗体检测阳性者；
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.既往有酒精或有任何疫苗或药物严重不良反应史（例如：过敏、荨麻疹、皮肤湿疹、过敏性紫癜、呼吸困难、血管神经性水肿等）；或有对乙酰氨基酚过敏史；
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。
第二剂接种排除标准：
如果在研究观察期间内出现以下任一情况，受试者需终止接种疫苗，但可以根据研究者判断继续其它研究步骤：
1.血妊娠试验阳性者（仅限育龄女性）；
2.第1剂疫苗接种后发生严重过敏反应或与疫苗接种有因果关系的严重不良事件（经研究者评估）；
3.第1剂接种后接种了除研究疫苗外的其他任何疫苗；
4.第1剂接种后有和新冠确诊病例密切接触史者；
5.在研究者认为不适合继续参加研究的其他原因。

Exclusion criteria：

Exclusion Criteria for Dose 1:
Subjects who meet any of the following exclusion criteria should be excluded from the study:
1. Individuals whose results from a complete physical examination do not meet the health standards, mainly include:
1) Abnormal vital signs with clinical significance (pulse < 50/min or > 100/min, systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg for a conscious adult);
2) BMI < 18 kg/m^2 or > 30 kg/m^2;
3) In the screening window period, the laboratory test value exceeds 1.2 ULN, and is determined by the investigator to be clinically significant;
2. Women in menstrual period at the day of administration, women in lactation period, or women who plan to conceive within 12 months from screening period to the end of complete series; men whose spouse plans to conceive, or those who plan to donate sperm and eggs;
3. Individuals with a history of vaccination with any COVID-19 vaccines;
4. Individuals with prior diagnosis as COVID-19 cases or suspected cases. Individuals who have a history of contact with COVID-19 cases or suspected cases within 1 month before signing the informed consent, or those who have overseas travel history or have traveled to areas with high incidence of COVID-19; COVID-19 infectors or carriers: those with positive results for serum SARS-CoV-2-specific antibodies or SARS-CoV-2 nucleic acid in throat swabs;
5. Individuals who are tested positive for hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum-specific antibody and human immunodeficiency virus antibody;
6. Individuals with a history of infections or diseases caused by SARS, MERS or other coronavirus;
7. Individuals who have acute diseases or are in acute attack of chronic diseases within 2 weeks prior to Dose 1, or have fever (axillary temperature ≥ 37.3℃) or upper respiratory tract infection within 7 days prior to Dose 1;
8. Individuals with a history of severe side effects induced by alcohol, any vaccine or any drug, (such as allergy, urticaria, eczema, dyspnea, angioneurotic edema, etc.); individuals with a history of allergy to acetaminophen;
9. Individuals who have been vaccinated with any vaccine within 1 month prior to Dose 1;
10. Individuals who cannot tolerate the venipuncture and who have fainting history during acupuncture or at the sight of blood;
11. Individuals who have hereditary bleeding tendency or coagulation dysfunction, or have history of thrombosis or bleeding, and those with abnormal detection results of coagulation-related measurements;
12. Individuals who have been diagnosed with congenital or acquired immunodeficiency (e.g., HIV infection);
13. Individuals who have asplenia or functional asplenia, or have other important organs removed by surgery for any reason;
14. Individuals who previously have serious diseases with abnormal clinical manifestations that needed to be excluded, including, but not limited to history of systemic diseases and malignant tumors for nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone system, excluding stable chronic diseases, such as diabetes, hypertension, etc.;
15. Individuals who have undergone any surgeries within 3 months prior to the signing of informed consent, or plan to have any surgeries during the trial period;
16. Individuals who had blood donation or blood loss (>=450 mL), blood transfusion or use of blood products within 3 months prior to the signing of the informed consent, or plan to donate blood during the trial period;
17. Individuals who used any investigational or unlicensed products (drug, vaccine, biological product or device) other than the study vaccine within 3 months prior to the signing of the informed consent, or plan to use the above-mentioned products during the study period;
18. Individuals who received immunosuppressive therapy within 6 months prior to signing the informed consent, such as long-term systemic glucocorticoid therapy (more than 2 weeks of continuous systemic glucocorticoid therapy, such as prednisone or similar drugs, within 6 months). Topical application (such as ointment, eye drops, inhalants or nasal sprays) is allowed. Topical medication should not exceed the dosage recommended in the prescribing information and the subjects should not have any signs of systemic exposure;
19. Individuals who have any other conditions that, in the opinion of the investigators, precludes study participation.

Exclusion Criteria for Dose 2:
If any of the following conditions occur during the observation period, the subjects should be terminated for subsequent doses, but other study procedures can be continued in the opinion of the investigator:
1. Female subjects who are tested positive in the blood pregnancy test;
2. Subjects who have serious allergic reactions or serious adverse events with causal relationship to vaccination after Dose 1 (as deemed by the investigators);
3. Subjects who are administered with any vaccine other than the investigational vaccine after Dose 2;
4. Subjects who have close contact with COVID-19 cases after Dose 1;
5. Subjects who have any other conditions that, in the opinion of the investigators, precludes further participation in the study.

研究实施时间：

Study execute time：

从 From 2021-08-04 00:00:00至 To 2022-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-08-04 00:00:00 至 To 2021-10-30 00:00:00

干预措施：

Interventions：

组别：

18-59岁组

样本量：

 180

Group：

18-59 years group

Sample size：

干预措施：

接种5×10^10vp试验疫苗或安慰剂

干预措施代码：

Intervention：

Investigational vaccine or placebo at the dose of 5×10^10vp

Intervention code：

组别：

≥60岁组

样本量：

 180

Group：

>=60 years group

Sample size：

干预措施：

接种5×10^10vp试验疫苗或安慰剂

干预措施代码：

Intervention：

Investigational vaccine or placebo at the dose of 5×10^10vp

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 云南 

市(区县)：

 昆明 

Country：

China

Province：

Yunnan

City：

Kunming

单位(医院)：

 祥云县疾病预防控制中心 

单位级别：

  

Institution
hospital：

Center for Disease Control and Prevention of Xiangyun County

Level of the institution：

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：

假病毒中和抗体

指标类型：

主要指标

Outcome：

Neutralizing antibody as measured by pseudovirus neutralization assay

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

真病毒中和抗体

指标类型：

主要指标

Outcome：

Neutralizing antibody as measured by wild-type virus neutralization assay

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

腺病毒载体（ChAdTS）中和抗体

指标类型：

次要指标

Outcome：

Netralizing antibodies against the adenovirus vector(ChAdTS)

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-mediated 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 samples

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 samples

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 岁 years
最大 Max age 80 岁 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)：

Randomization codes will be generated by an unblinded statistician responsible for randomization using SAS statistical software (version 9.4) with the block randomization method.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Not stated

Blinding：

Not stated

是否共享原始数据：

IPD sharing

否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

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.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-08-02 14:17:47