Today is 2020-12-02

A Phase I 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:

ChiCTR2000037782 

最近更新日期:

Date of Last Refreshed on:

2020-09-08 

注册时间:

Date of Registration:

2020-09-01 

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疫苗 (DelNS1-2019-nCoV-RBD- OPT1)Ⅰ期临床试验 

Public title:

A Phase I 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)Ⅰ期临床试验 

Scientific title:

A Phase I 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 13693666659 

研究负责人电话:

Study leader's telephone:

+86 13951994867 

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:

102206 

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-A039-01 

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:

2020-08-31 

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, 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 Distinct

单位(医院):

北京万泰生物药业股份有限公司

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

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:

I期临床试验 

Study phase:

研究目的:

主要目的: 评价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: 1)初步评价鼻喷流感病毒载体新冠肺炎疫苗(DelNS1-2019-nCoV-RBD-OPT1)的免疫原性; 2)健康人群中预存甲型H1N1流感病毒(A/California/4/2009, CA4)抗体对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; 3)鼻喷流感病毒载体新冠肺炎疫苗(DelNS1-2019-nCoV-RBD-OPT1)接种后的疫苗株排毒情况。 

Objectives of Study:

Primary purpose: Influenza virus Vector COVID-19 Vaccine for intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1) was evaluated for its safety. Exploratory purpose: 1) Influenza virus Vector COVID-19 Vaccine for intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1) was immunized; 2) The effect of pre-existing antibodies against influenza A (H1N1) virus (A/California/4/2009, CA4) on the immunogenicity of Influenza virus Vector COVID-19 Vaccine for intranasal Spray(DelNS1-2019-nCoV-RBD-OPT1) in healthy population; 3) The virus excretion of the vaccine strain after Influenza virus Vector COVID-19 Vaccine for intranasal Spray(DelNS1-2019-nCoV-RBD-OPT1) vaccination. 

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)新型冠状病毒核酸检测阴性; 4)新型冠状病毒血清总抗体检测阴性; 5)肺部CT影像学正常(无新型冠状病毒肺炎影像学特征); 6)HIV筛查结果阴性; 7)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) Aged >=18 years old at the time of enrollment; 2) Be able to comply with the requirements of the clinical research protocol, complete all trial procedures, and sign the informed consent form; 3) The nucleic acid test of SARS-CoV-2 is negative; 4) The serum total antibody test of SARS-CoV-2 is negative; 5) The lung CT imaging is normal (no imaging features of COVID-19); 6) The HIV screening result is negative; 7) 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)接种疫苗前21天有新冠病毒肺炎患者密切接触史; 3)有重症急性呼吸综合征(SARS)或中东呼吸综合征(MERS)病史者; 4)女性血妊娠试验阳性者,或正处于妊娠期、哺乳期妇女; 5)嗜烟者或试验前3个月每日吸烟量多于5支者; 6)有过敏性鼻炎病史者; 7)接种疫苗前3天内患有急性鼻窦炎或慢性鼻窦炎伴有急性发作期症状的受试者; 8)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; 9)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; 10)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; 11)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; 12)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; 13)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; 14)接种疫苗前6个月内接种过流感疫苗者; 15)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; 16)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; 17)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); 18)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; 19)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; 20)自述既往有凝血障碍或凝血功能异常者; 21)血常规、血生化、凝血功能及尿常规检测结果经临床医生判定具有临床意义; 22)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) Subaxillary body temperature >37.0 degree C; 2) A history of close contact with patients with COVID-19 within 21 days before vaccination; 3) Those with a history of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS); 4) Women with positive blood pregnancy test, or women in pregnancy or lactation period; 5) Smokers or those who smoked more than 5 cigarettes a day in the three months before the trial; 6) Those with a history of allergic rhinitis; 7) Subjects suffering from acute sinusitis or chronic sinusitis with acute exacerbation symptoms within 3 days before vaccination; 8) Abnormalities in the nasal cavity, such as granulomas in the nasal cavity, deviation of the nasal septum, and nasal polyps, which may affect the specimen collection or vaccination according to the clinician's judgment; 9) Those who had fever (Subaxillary body temperature ≥ 38.0 ℃) 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 anti-influenza virus drugs such as Tamiflu, Relenza, Symmetrel or flumadine); 10) 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.; 11) People with immunodeficiency diseases, primary diseases of vital organs, cancer, immune diseases (including Guillain Barre syndrome, systemic lupus erythematosus, rheumatoid arthritis, no spleen or splenectomy due to any condition, and other immune diseases that researchers believe may have an impact on the immune response), etc.; 12) Have received immunoglobulin and / or blood preparations within 3 months before vaccination, or plan to use them during the study period; 13) Received subunit or inactivated vaccine within 14 days before vaccination, or received live attenuated vaccine within 28 days before vaccination; 14) Those who have received influenza vaccine within 6 months before vaccination; 15) 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; 16) Have received any intranasal drug treatment or nasal surgery within 7 days before vaccination; 17) long term (lasting more than 14 days) use of immunosuppressants and other immunomodulatory drugs, or systemic use of corticosteroids (topical ointment, eye drops, inhalers, etc. are allowed, but nasal spray is not included) within 6 months before vaccination; 18) 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 those who are allergic to any component of the vaccine used in this trial; 19) Those who have taken aspirin, drugs containing aspirin or salicylate within 14 days before vaccination or plan to use them in this trial; 20) Those who reported having coagulation disorder or abnormal coagulation function in the past; 21) The results of blood routine, blood biochemistry, coagulation function and urine routine tests are judged by clinicians to have clinical significance; 22) 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:

From2020-09-01To 2021-10-01 

征募观察对象时间:

Recruiting time:

From2020-09-01To 2021-10-01 

干预措施:

Interventions:

组别:

试验组

样本量:

48

Group:

Experimental group

Sample size:

干预措施:

接种试验疫苗

干预措施代码:

Intervention:

vaccination

Intervention code:

组别:

安慰剂对照组

样本量:

12

Group:

Placebo control group

Sample size:

干预措施:

接种安慰剂对照疫苗

干预措施代码:

Intervention:

vaccination

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

东台市 

Country:

China 

Province:

Jiangsu 

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:

每剂次接种后14天内的局部和全身不良反应/事件

指标类型:

主要指标 

Outcome:

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

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

每剂次接种后 30天内的所有不良反应/事件

指标类型:

主要指标 

Outcome:

All adverse reactions/events within 30 days after each dose

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

整个研究期内的严重不良事件(SAE)

指标类型:

主要指标 

Outcome:

Serious adverse events (SAE) throughout the study period

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疫苗接种前与接种后3天的实验室指标变化(血常规、血生化、凝血功能及尿常规)

指标类型:

次要指标 

Outcome:

Changes in laboratory indicators before vaccination and 3 days after vaccination (blood routine, blood biochemistry, coagulation function and urine routine)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清抗新型冠状病毒总抗体、IgG抗体、中和抗体的阳转率、抗体水平及免疫持久性

指标类型:

附加指标 

Outcome:

Serum anti-SARS-CoV-2 total antibody, IgG antibody, neutralizing antibody positive conversion rate, antibody level and immunity persistence

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

鼻咽拭子抗新型冠状病毒总抗体、IgA抗体的阳转率、抗体水平及免疫持久性

指标类型:

附加指标 

Outcome:

Nasopharyngeal swab anti-SARS-CoV-2 total antibody, IgA antibody positive conversion rate, antibody level and immune persistence

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全血新型冠状病毒刺突蛋白特异性细胞免疫应答水平(PBMC刺激培养后分泌IL-2、IFN-γ和TNF-α的阳性率及相对水平)

指标类型:

附加指标 

Outcome:

The level of specific cellular immune response of SARS-CoV-2 spike protein in whole blood (the positive rate and relative level of IL-2, IFN-gama and TNF-alpha secreted after PBMC stimulation and culture)

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清抗骨架甲型H1N1流感病毒(CA4 )IgG抗体的阳转率、抗体水平及免疫持久性

指标类型:

附加指标 

Outcome:

The positive conversion rate, antibody level and immunity persistence of serum anti-skeleton H1N1 influenza virus (CA4) IgG antibody

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

鼻咽拭子抗骨架甲型H1N1流感病毒(CA4 )IgA抗体的阳转率、抗体水平及免疫持久性

指标类型:

附加指标 

Outcome:

Nasopharyngeal swab anti-skeletal influenza A H1N1 (CA4) IgA antibody positive conversion rate, antibody level and immune persistence

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

人体预存甲型H1N1流感病毒(CA4 )血清HI(血凝抑制)抗体阳性率和抗体水平与新冠病毒特异性免疫应答各项指标的相关性

指标类型:

附加指标 

Outcome:

Correlation between the positive rate of serum HI (hemagglutination inhibition) antibody and antibody level of pre-existing influenza A H1N1 virus (CA4) in human body and various indicators of SARS-CoV-2 specific immune response

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

鼻咽拭子和血清疫苗株排毒水平(RNA含量)

指标类型:

附加指标 

Outcome:

Nasopharyngeal swab and serum vaccine strain detoxification level (RNA content)

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

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:

标本中文名:

咽拭子

组织:

Sample Name:

Throat swab

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

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:

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):

采用区组随机设计,每个随机区组包含若干个随机编号,每个随机编号对应三支相同的试验疫苗或安慰剂疫苗(其中一支为备用疫苗)。各阶段受试者在完成首剂疫苗接种前的相关访视流程后,根据到达接种点的顺序,按照4:1的比例随机分配至试验臂和安慰剂对照臂。

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

A block random design is adopted. Each random block contains several random numbers, and each random number corresponds to three identical test vaccines or placebo vaccines (one of which is a backup vaccine).

盲法:

双盲

Blinding:

Double blind

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

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:

EDC系统

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

EDC system

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-09-01
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