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A Phase II Clinical Trial of Influenza virus Vector COVID-19 Vaccine for intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1)
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注册号:

Registration number:

ChiCTR2000039715 

最近更新日期:

Date of Last Refreshed on:

2020-11-06 

注册时间:

Date of Registration:

2020-11-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

鼻喷流感病毒载体新冠肺炎(COVID-19)疫苗 (DelNS1-2019-nCoV-RBD- OPT1)Ⅱ期临床试验 

Public title:

A Phase II Clinical Trial of Influenza virus Vector COVID-19 Vaccine for intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1)  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

鼻喷流感病毒载体新冠肺炎疫苗 (DelNS1-2019-nCoV-RBD- OPT1)Ⅱ期临床试验 

Scientific title:

A Phase II Clinical Trial of Influenza virus Vector COVID-19 Vaccine for intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1)  

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:

叶祥忠 

研究负责人:

朱凤才 

Applicant:

Xiangzhong Ye 

Study leader:

Fengcai Zhu 

申请注册联系人电话:

Applicant telephone:

+86 010-59528966-5089 

研究负责人电话:

Study leader's telephone:

+86 025-83759418 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+86 025-83759529 

申请注册联系人电子邮件:

Applicant E-mail:

yexiangzhong@ystwt.com 

研究负责人电子邮件:

Study leader's E-mail:

jszfc@vip.sina.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:

北京市昌平区科学园路31号 

研究负责人通讯地址:

江苏省南京市鼓楼区江苏路172号 

Applicant address:

31 Science Park Road, Changping District, Beijing, China 

Study leader's address:

172 Jiangsu Road, Gulou District, Nanjing City, Jiangsu Province 

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:

210009 

申请人所在单位:

北京万泰生物药业股份有限公司 

Applicant's institution:

Beijing WANTAI Biological Pharmacy Enterprise 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:

JSJK2020-A061-01 

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:

江苏省疾病预防控制中心伦理审查委员会 

Name of the ethic committee:

Ethics Committee of Jiangsu Provincial Center for Disease Prevention and Control 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-10-29 

伦理委员会联系人:

蔡慧媛 

Contact Name of the ethic committee:

Huiyuan Cai 

伦理委员会联系地址:

江苏省南京市鼓楼区江苏路172号 

Contact Address of the ethic committee:

172 Jiangsu Road, Gulou District, Nanjing District, Jiangsu, 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:

江苏省疾病预防控制中心(江苏省公共卫生研究院) 

Primary sponsor:

Jiangsu Provincial Center For Disease Control and Prevention (Public Health Research Institute of Jiangsu Province) 

研究实施负责(组长)单位地址:

江苏省南京市鼓楼区江苏路172号 

Primary sponsor's address:

172 Jiangsu Road, Gulou District, Nanjing District, Jiangsu, 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):

昌平区

Country:

China

Province:

Beijing

City:

Changping District

单位(医院):

北京万泰生物医药股份有限公司

具体地址:

北京市昌平区科学园路31号

Institution
hospital:

Beijing WANTAI Biological Pharmacy Enterprise Co.,Ltd.

Address:

31 Science Park Road, Changping District, Beijing, China

经费或物资来源:

完全自筹 

Source(s) of funding:

Self financing 

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:

主要目的: 评价按照不同免疫程序接种鼻喷流感病毒载体新冠肺炎疫苗(DelNS1-2019-nCoV-RBD-OPT1)的免疫原性。 次要目的: 评价按照不同免疫程序接种鼻喷流感病毒载体新冠肺炎疫苗(DelNS1-2019-nCoV-RBD-OPT1)的安全性。 探索性目的: 健康人群中预存甲型H1N1流感病毒(A/California/4/2009, CA4)抗体对按照不同免疫程序接种鼻喷流感病毒载体新冠肺炎疫苗(DelNS1-2019-nCoV-RBD-OPT1)免疫原性的影响。 

Objectives of Study:

Primary purpose: To evaluate the immunogenicity of Influenza virus Vector COVID-19 Vaccine for intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1) according to different immunization procedures. Secondary purpose: To evaluate the safety of Influenza virus Vector COVID-19 Vaccine for intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1) according to different immunization procedures. Exploratory purpose: The effect of pre-existing H1N1 influenza virus (A/California/4/2009, CA4) antibodies on the immunogenicity of Influenza virus Vector COVID-19 Vaccine for intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1) according to different immunization procedures in healthy 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)入组时年龄满18周岁; 2)能遵守临床研究方案的要求完成所有试验程序,并且签署知情同意书; 3)2019年12月至今未去过出现疫情的地区,未接触新冠感染者或疑似病例,处于非隔离期内的人员,且同村/社区内未出现新冠感染者或疑似病例; 4)新型冠状病毒总抗体检测(胶体金法)阴性; 5)对于女性受试者,需在首剂疫苗接种后12个月内无妊娠计划并同意使用有效避孕措施; 

Inclusion criteria

1. Be at least 18 years old at the time of enrollment; 2. Be able to comply with the requirements of clinical research protocol, complete all trial procedures, and sign the informed consent form; 3. Since December 2019, those who have not been to an area where an epidemic has occurred, have not been in contact with a person with a SARS-CoV-2 infection or a suspected case, a person in a non-quarantine period, and there has been no SARS-CoV-2 infected person or a suspected case in the same village/community; 4. SARS-CoV-2 total antibody test (colloidal gold method) is negative; 5. For female subjects, they must have no pregnancy plan within 12 months after the first dose of vaccination and agree to use effective contraceptive measures. 

排除标准:

1)腋下体温>37.0℃; 2)有重症急性呼吸综合征(SARS)或中东呼吸综合征(MERS)病史者; 3)女性尿妊娠试验阳性者,或正处于妊娠期、哺乳期妇女; 4)接种疫苗前3天内患有急性鼻窦炎、急性鼻炎,或慢性鼻窦炎、慢性鼻炎伴有急性发作期症状的受试者; 5)鼻腔内肉芽肿、鼻中隔偏曲、鼻息肉等经临床医生判断可能影响标本采集或疫苗接种的鼻腔内异常情况; 6)接种疫苗前3天内曾发热(腋下体温≥38.0℃)或过去5天内曾患有任何急性疾病且需要全身应用抗生素或抗病毒(包括但不限于使用奥司他韦(Tamiflu),扎那米韦(Relenza),金刚烷胺(Symmetrel)或金刚乙胺(Flumadine)等抗流感病毒药物)治疗者; 7)患有严重慢性内科疾病或使用药物后病情不能平稳控制者,如高血压(收缩压≥140mmHg或舒张压≥90mmHg)、糖尿病、哮喘、甲状腺疾病等; 8)患有免疫缺陷疾病,重要脏器有原发性疾病者、癌症、免疫性疾病(包括格林巴利综合症、系统性红斑狼疮、类风湿关节炎、任何情况导致的无脾或脾切除以及其他研究者认为可能对免疫应答反应有影响的免疫性疾病)等; 9)接种疫苗前3个月内接受过免疫球蛋白和/或血液制剂,或计划在研究期间内使用者; 10)接种疫苗前14 天内接受过亚单位或灭活疫苗,或前28天内接受过减毒活疫苗; 11)接种疫苗前1个月内接受过其他研究性药物或疫苗,或计划在研究期间使用其他研究性药物或疫苗者; 12)接种疫苗前7天内接受过任何鼻内药物治疗或鼻外科治疗; 13)接种疫苗前6个月内曾长期(持续14天以上)使用免疫抑制剂及其他免疫调节药物,或皮质类固醇药物的全身性用药(允许局部的软膏、滴眼液、吸入剂等用药,但不包含鼻喷剂); 14)有严重过敏史,包括既往接种疫苗有过严重的不良反应,如过敏、荨麻疹、呼吸困难、血管神经性水肿等,或对本试验用疫苗任一组分过敏者; 15)接种疫苗前14天内曾服用或计划试验期间使用阿司匹林、含有阿司匹林或水杨酸盐的药物者; 16)自述既往有凝血障碍或凝血功能异常者; 17)研究者经询问受试者病史及相关体检后判断,由于各种医疗、心理、社会条件、职业因素或其他条件,可能影响临床研究进行的。 

Exclusion criteria:

1) Axillary temperature>37.0 degree C; 2) Those with a history of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS); 3) Women with a positive urine pregnancy test, or women in pregnancy or lactation period; 4) Subjects suffering from acute sinusitis, acute rhinitis, or chronic sinusitis or chronic rhinitis with acute exacerbation symptoms within 3 days before vaccination; 5) Abnormalities in the nasal cavity, such as granulomas in the nasal cavity, deviation of the nasal septum, and nasal polyps, which may affect specimen collection or vaccination according to the clinician's judgment; 6) Those who had fever (axillary temperature >=38.0 degree C) within 3 days before vaccination or had any acute disease in the past 5 days and needed systemic antibiotic or antiviral treatment (including but not limited to the use of oseltamiflu (Tamiflu), Namivir (Relenza), amantadine (Symmetrel) or rimantadine (Flumadine) and other anti-influenza virus drugs); 7) People who suffer from severe chronic medical diseases or whose condition cannot be controlled smoothly after using drugs, such as hypertension (systolic blood pressure >=140mmHg or diastolic blood pressure >=90mmHg), diabetes, asthma, thyroid disease, etc.; 8) People with immunodeficiency diseases, primary diseases of important organs, cancer, immune diseases (including Guillain Barre syndrome, systemic lupus erythematosus, rheumatoid arthritis, asthenia or splenectomy due to any condition and other immune diseases that researchers believe may have an impact on the immune response), etc.; 9) Received immunoglobulin and/or blood preparations within 3 months before vaccination, or plan to use them during the study period; 10) Received subunit or inactivated vaccine within 14 days before vaccination, or received live attenuated vaccine within 28 days before vaccination; 11) Those who have received other research drugs or vaccines within 1 month before vaccination, or plan to use other research drugs or vaccines during the study period; 12) Have received any intranasal drug treatment or nasal surgery within 7 days before vaccination; 13) Long-term use of immunosuppressants and other immunomodulatory drugs, or systemic use of corticosteroid drugs (topical ointment, eye drops, inhalers, etc. are allowed, but nasal spray is not included) within 6 months before vaccination; 14) People who have a history of severe allergies, including those who have had serious adverse reactions from previous vaccination, such as allergies, urticaria, dyspnea, angioedema, etc., or allergic to any component of the vaccine used in this study; 15) Those who have taken aspirin, drugs containing aspirin or salicylate within 14 days before vaccination or planned to use them in this study; 16) those who reported having coagulation disorder or abnormal coagulation function in the past; 17) The investigator judged after inquiring the subject's medical history and related physical examinations that various medical, psychological, social conditions, occupational factors, or other conditions may affect the conduct of clinical research. 

研究实施时间:

Study execute time:

From2020-11-17To 2021-12-17 

征募观察对象时间:

Recruiting time:

From2020-11-17To 2021-12-17 

干预措施:

Interventions:

组别:

试验组(0、14天免疫程序)

样本量:

240

Group:

Experimental group

Sample size:

干预措施:

0、14天接种试验疫苗

干预措施代码:

Intervention:

0,14 day immunization procedure

Intervention code:

组别:

对照组(0、14天免疫程序)

样本量:

120

Group:

Control group

Sample size:

干预措施:

0、14天接种安慰剂对照疫苗

干预措施代码:

Intervention:

0,14 day placebo of immunization procedure

Intervention code:

组别:

试验组(0、21天免疫程序)

样本量:

240

Group:

Experimental group

Sample size:

干预措施:

0、21天接种试验疫苗

干预措施代码:

Intervention:

0, 21 day immunization procedure

Intervention code:

组别:

对照组(0、21天免疫程序)

样本量:

120

Group:

Controll group (0,21 day immunization procedure)

Sample size:

干预措施:

0、21天接种安慰剂对照疫苗

干预措施代码:

Intervention:

0,21 day placebo of immunization procedure

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏省 

市(区县):

东台市 

Country:

China 

Province:

Jiangsu Province 

City:

Dongtai 

单位(医院):

江苏省东台市疾病预防控制中心 

单位级别:

市疾病预防控制中心 

Institution
hospital:

Dongtai Center for Disease Control and Prevention  

Level of the institution:

CDC 

测量指标:

Outcomes:

指标中文名:

末剂疫苗接种后1m血清新型冠状病毒总抗体、IgG抗体、中和抗体(若抗新冠病毒总抗体阳性,则进一步检测IgG和中和抗体的阳转率和抗体水平)

指标类型:

主要指标 

Outcome:

Serum total antibodies, IgG antibodies, and neutralizing antibodies of SARS-CoV-2 one month after the last dose of vaccination (if the total antibodies against SARS-CoV-2 are positive, the positive conversion rate and antibody levels of IgG and neutralizing antibodies will be further tested)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

末剂疫苗接种后1m鼻咽拭子新型冠状病毒总抗体、IgA抗体、中和抗体(若抗新冠病毒总抗体阳性,则进一步检测IgA抗体和中和抗体)的阳转率和抗体水平

指标类型:

主要指标 

Outcome:

The positive conversion rate and antibody level of SARS-CoV-2 total antibody, IgA antibody, and neutralizing antibody in nasopharyngeal swabs (if the total anti- SARS-CoV-2 antibody is positive, the IgA antibody and neutralizing antibody will be further tested) one month after the last dose of vaccination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

末剂疫苗接种后14d全血新冠病毒刺突蛋白特异性细胞免疫应答水平

指标类型:

主要指标 

Outcome:

The specific cellular immune response level of SARS-CoV-2 spike protein in whole blood 14 days after the last dose of vaccination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

每剂接种后14d内的局部和全身不良反应/事件

指标类型:

次要指标 

Outcome:

Local and systemic adverse reactions/events within 14 days after each dose

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

每剂接种后42d内的所有不良反应/事件

指标类型:

次要指标 

Outcome:

All adverse reactions/events within 42 days after each dose

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

整个研究期(全程接种后12m)内严重不良事件(SAE)

指标类型:

次要指标 

Outcome:

Serious adverse events (SAE) during the entire study period (12 months after the full vaccination)

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:

鼻咽拭子

组织:

Sample Name:

Nasopharyngeal swab

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 ≥60 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):

应用SAS 9.4软件,按照分层区组随机方法进行随机。

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

Randomize according to the stratified block random method with SAS 9.4 software.

盲法:

双盲

Blinding:

Double blind

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):

根据要求

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

upon request

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:

eCRF,EDC系统

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

eCRF,EDC system

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-11-06
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