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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:

2021-02-11 

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 10-59528966-5089 

研究负责人电话:

Study leader's telephone:

+86 25-83759418 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+86 25-83759529 

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, Jiangsu, 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:

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, 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, 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:

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:

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. Subjects over 18 years old at the time of enrollment; 2. The subjects who can comply with the requirements of the clinical study protocol, complete all the trial procedures, and sign the informed consent form; 3. Since December 2019, the subjects who have not been to the epidemic area, have not contacted the new coronal infection or suspected cases, and are in the non isolation period, and there are no new coronal infection or suspected cases in the same village / community; 4. New Coronavirus total antibody test (colloidal gold method) negative subjects; 5. For female subjects, they should have no pregnancy plan within 12 months after the first dose of vaccine 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. Subjects with axillary body temperature above 37.0 degrees C; 2. Patients with history of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (mers); 3. Female subjects with positive urine pregnancy test, or pregnant or lactating women; 4. Subjects with acute sinusitis or acute rhinitis within 3 days before vaccination, or subjects with chronic sinusitis or chronic rhinitis accompanied with acute attack symptoms; 5. Patients with intranasal granuloma, nasal septum deviation, nasal polyps and other abnormal conditions that may affect specimen collection or vaccination judged by clinicians; 6. Subjects who had fever within 3 days before vaccination (axillary temperature >= 38.0 degrees C) or who had any acute disease in the past 5 days and needed systemic application of antibiotics or antiviral drugs (including but not limited to the use of antiviral drugs such as Tamiflu, Relenza, symmetry or flumadine); 7. Subjects with severe chronic medical diseases or whose condition can not be controlled smoothly after using drugs, such as hypertension (systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg), diabetes, asthma, thyroid diseases, etc; 8. Patients with immune deficiency diseases, including primary diseases, cancer, immune diseases (including Guillain Barre syndrome, systemic lupus erythematosus, rheumatoid arthritis, splenectomy or splenectomy caused by any condition, and other immune diseases that researchers think may affect immune response), etc; 9. Subjects who received immunoglobulin and / or blood preparations within 3 months before vaccination, or planned to use them during the study period; 10. Subjects who received subunit or inactivated vaccine within 14 days before vaccination, or who received live attenuated vaccine within 28 days before vaccination; 11. Subjects who have received other research drugs or vaccines within one month before vaccination, or who plan to use other research drugs or vaccines during the research period; 12. Subjects who received any intranasal medication or nasal surgery within 7 days before vaccination; 13. Subjects who used immunosuppressants and other immunomodulatory drugs for a long time (lasting for more than 14 days) within 6 months before vaccination, or systemic use of corticosteroids (local ointment, eye drops, inhalers, etc. are allowed, but nasal spray is not included); 14. Subjects with a history of severe allergy, including those who have had severe adverse reactions such as allergy, urticaria, dyspnea, angioneurotic edema, etc., or who are allergic to any component of the vaccine used in this trial; 15. Subjects who had taken or planned to use aspirin, drugs containing aspirin or salicylate within 14 days before vaccination; 16. Subjects who reported coagulation disorders or coagulation dysfunction in the past; 17. After inquiring about the subjects' medical history and related physical examination, the researcher judged that various medical, psychological, social, occupational or other conditions may affect the progress 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 

市(区县):

东台 

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:

Jiangsu Dongtai Center for Disease Control and Prevention  

Level of the institution:

CDC 

测量指标:

Outcomes: