注册号: Registration number: |
ChiCTR2100051391 |
最近更新日期: Date of Last Refreshed on: |
2022-12-04 |
注册时间: Date of Registration: |
2021-09-22 |
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)III期临床试验 |
Public title: |
A Phase III Clinical Trial of Influenza Virus Vector COVID-19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1) |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
评价鼻喷流感病毒载体新冠肺炎疫苗(DelNS1-2019-nCoV-RBD-OPT1)在18 岁及以上成人受试者中的保护效力、安全性的国际多中心、随机、双盲、安慰剂对照的III期临床试验 |
Scientific title: |
A Global, Multi-center, Randomized, Double-blind, Placebo Controlled Phase III Clinical Trial to Evaluate the Protective Efficacy and Safety of Influenza Virus Vector COVID-19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1) in Adults Aged 18 Years and Older |
研究课题代号(代码): Study subject ID: |
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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: |
Ye Xiangzhong |
Study leader: |
Zhu Fengcai |
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: |
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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): |
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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 Kexueyuan Road, Changping District, Beijing |
Study leader's address: |
172 Jiangsu Road, Gulou District, Nanjing, Jiangsu |
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: |
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申请人所在单位: |
北京万泰生物药业股份有限公司 |
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Applicant's institution: |
Beijing Wantai Biological Pharmacy Enterprise Co.,Ltd. |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
201/CN-HDDD |
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: |
卫生部国家生物医学研究伦理委员会 |
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Name of the ethic committee: |
MINISTRY OF HEALTH NATIONAL ETHICS COMMITTEE IN BIOMEDICAL RESEARCH |
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伦理委员会批准日期: Date of approved by ethic committee: |
2022-10-17 | ||
伦理委员会联系人: |
张越勇 |
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Contact Name of the ethic committee: |
Yueyong Zhang |
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伦理委员会联系地址: |
No138A江武街 - 巴丁区 - 河内市 |
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Contact Address of the ethic committee: |
138A Giang Vo St., Ba Dinh Dist., Ha Noi City |
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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: |
N/A |
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Primary sponsor: |
N/A |
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研究实施负责(组长)单位地址: |
N/A |
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Primary sponsor's address: |
N/A |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹 |
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Source(s) of funding: |
Self-raised |
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研究疾病: |
新型冠状病毒肺炎(COVID-19) |
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Target disease: |
Novel Coronavirus Pneumonia (COVID-19) |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
III期临床试验 | ||||||||||||||||||||||
Study phase: |
3 |
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研究目的: |
主要目的: 1.评价DelNS1-2019-nCoV-RBD-OPT1预防病毒学确诊(RT-PCR阳性)的症状性COVID-19的保护效力; 2.评价DelNS1-2019-nCoV-RBD-OPT1的安全性。 次要目的: 1.分别评价既往无或有新型冠状病毒疫苗免疫史受试者中DelNS1-2019-nCoV-RBD-OPT1预防病毒学确诊(RT-PCR阳性)的症状性COVID-19的保护效力; 2.评价DelNS1-2019-nCoV-RBD-OPT1预防重型COVID-19的保护效力; 3.评价不同年龄组中DelNS1-2019-nCoV-RBD-OPT1预防任何严重程度的症状性COVID-19的保护效力; 4.评价DelNS1-2019-nCoV-RBD-OPT1预防病毒学确诊(RT-PCR阳性)的COVID-19死亡的保护效力; 5.评价慢性疾病患者中DelNS1-2019-nCoV-RBD-OPT1预防任何严重程度的症状性COVID-19的保护效力。 |
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Objectives of Study: |
Primary objective: 1.To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 for preventing virologically confirmed (RT-PCR-positive) symptomatic COVID-19; 2.To evaluate the safety of DelNS1-2019-nCoV-RBD-OPT1. Secondary objectives: 1. To respectively evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 for preventing virologically confirmed (RT-PCR-positive) symptomatic COVID-19 in subjects with and without COVID-19 vaccination history; 2.To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against severe COVID-19; 3.To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against symptomatic COVID-19 of any severity in different age groups; 4.To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against virologically -confirmed (RT-PCR-positive) COVID-19 deaths; 5.To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against symptomatic COVID-19 of any severity in patients with chronic diseases. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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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.未接种过任何新型冠状病毒疫苗(已上市的或在研的),或者已接种其他的新型冠状病毒疫苗(已上市的或在研的)至少1剂,且最后1剂接种时间距离本研究受试者签署知情同意日期>=6个月; 4.艾滋病病毒(HIV)筛查阴性者(按照试验所在国的相关政策进行,如有的国家HIV检测需要有资质,则以问询为主,同时需要注意保护受试者隐私); 5.具有生育能力的男性和育龄期女性自愿从签署知情书开始至末次疫苗接种完成后3个月使用适当的避孕措施,包括禁欲或有效的避孕措施(如宫内或植入式避孕装置,口服避孕药,子宫隔膜或避孕套与避孕凝胶结合使用);育龄期女性在接种日的妊娠试验结果呈阴性; 6.健康受试者或存在轻度基础疾病的受试者[入选本研究前至少3个月处于病情未加重(无须入院治疗或治疗方案无重大调整等)的稳定状态]。 |
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Inclusion criteria |
1.Aged >= 18 years old at the time of enrollment; 2.Be able to comply with the requirements of clinical study protocol and complete all trial procedures, and sign informed consent form; 3.Subjects who have not received any COVID-19 vaccine (marketed or investigational), those who have received at least one dose of other COVID-19 vaccines (marketed or investigational) with an interval of >= 6 months between the last dose and the date when the subjects sign the informed consent for this study; 4.Patients who are negative for HIV screening (depending on the relevant policy of the country where the trial is conduct, if qualification for HIV testing is required in the country, this information will be obtained mainly by inquiry while protecting the candidates privacy); 5.Fertile males and females of childbearing potential who are willing to take appropriate contraceptive measures from signing inform consent form to 3 months after the last dose, including abstinence or effective contraceptive measures (e.g., intrauterine or implantable contraceptive devices, oral contraception, combination of contraceptive diaphragm or condom with contraceptive gel); women of childbearing potential should be negative for pregnancy test on the day of vaccination; 6.Healthy people or people with a mild underlying disease that has remained stable without exacerbation (not requiring hospitalization or without major modification of the treatment regimen) within at least 3 months prior to inclusion in the study. |
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排除标准: |
1.既往COVID-19感染病史或筛选时SARS-CoV-2 RT-PCR检测阳性; 2.筛选时SARS-CoV-2特异性总抗体胶体金试剂检测结果阳性的受试者[仅适用于无新型冠状病毒疫苗(已上市的或在研的)接种史的受试者]; 3.妊娠或哺乳期女性; 4.接种疫苗当天或前3天内发热(口温>=37.5℃/耳温≥37.5℃/腋温>=37.3℃); 5.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; 6.患有免疫缺陷疾病、重要脏器疾病、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)等导致免疫功能低下者; 7.首剂疫苗接种前6个月内长期服用(定义为14天以上)免疫抑制剂或其他免疫调节药物(对于皮质类固醇,如>=10 mg/天强的松或相当剂量;允许使用吸入和局部类固醇); 8.有出血性疾病史(如因子缺乏症、血小板减少症等凝血功能障碍性疾病),或有出血倾向者,或需要持续使用抗凝药; 9.接种研究疫苗前3个月内注射过免疫球蛋白和/或任何血液制品; 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个月内接受过其他药物临床试验,或计划在研究期间参加其他药物临床试验; 12.严重过敏反应史或既往免疫接种有严重不良反应,或对研究疫苗的任何成分过敏; 13.研究者认为不适合鼻喷给药的患者(如有严重鼻炎、鼻腔畸形等); 14.计划研究结束前从本地区永久搬迁或在研究访视期间长期(影响预定的访视时间)离开本地; 15.研究者认为不适宜参加试验的其他情况。 |
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Exclusion criteria: |
1.Prior history of COVID-19, or SARS-CoV-2 RT-PCR-positive at screening; 2.Positive test of total SARS-CoV-2 specific antibody using colloidal gold reagent [Only applicable to subjects without vaccination history of COVID-19 vaccine (marketed or investigational)]; 3.Pregnant or lactating women; 4.Fever on the day of vaccination or within 3 days prior to vaccination (oral temperature >= 37.5 ℃/ear temperature >= 37.5℃ /axillary temperature >= 37.3 ℃); 5.Patients who had any acute disease in the past 5 days that requires systemic antibiotic or antiviral treatment (including but not limited to the use of anti-influenza virus drugs such as Tamiflu, Relenza, Symmetrel or Flumadine); 6.Patients who had low immune function caused by immunodeficiency diseases, diseases of important organs, cancer, and immune diseases (e.g. Guillain Barre syndrome, systemic lupus erythematosus, rheumatoid arthritis, alienia or splenectomy caused by any condition, and other immune disease that may affect immune response at the investigators discretion); 7.Long-term use (defined as >= 14 days) of immunosuppressants or other immunomodulators (for glucocorticoids, e.g., >= 10 mg/day prednisone or equivalent dose; inhaled and topical steroids are allowed) within 6 months prior to the first vaccination; 8.History of hemorrhagic diseases (e.g., factor deficiency, thrombocytopenia or other coagulation disorders), or hemorrhagic tendency, or continuous requirement of anticoagulants; 9.Having received immunoglobulins and/or blood products within 3 months before receiving the investigational vaccine; 10.Received subunit or inactivated vaccine within 14 days before vaccination, or received live attenuated vaccine within 28 days before vaccination; 11.Participation in a clinical trial of another product within 1 month prior to vaccination, or planning to participate in a clinical trial of another product during the study; 12.Having a history of severe allergic reactions or severe adverse reactions from previous immunizations, or allergy to any component of the investigational vaccine; 13.Patients deemed by the investigator as unsuitable for using nasal spray (those with severe rhinitis or nasal deformities, etc.); 14.Planning to relocate permanently from the current area prior to the completion of the study or to leave the current area for a long period (preventing compliance with the prescribed visit schedule) during the study visits; 15.Other conditions that the investigators consider unsuitable for this clinical study. |
研究实施时间: Study execute time: |
从From2021-12-16至To 2023-06-30 |
征募观察对象时间: Recruiting time: |
从From2021-12-13至To 2022-05-31 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
结束 Completed |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
按照分层区组随机方法进行随机 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
To carry out randomization according to the stratified block randomization method. |
盲法: |
双盲。 |
Blinding: |
Double blind. |
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): |
未说明。 |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Not stated. |
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. |
数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |