注册号: Registration number: |
ChiCTR2100050849 |
最近更新日期: Date of Last Refreshed on: |
2022-05-08 |
注册时间: Date of Registration: |
2021-09-05 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
评价重组新型冠状病毒疫苗(CHO细胞)在18周岁及以上成年人中的保护效力、安全性和免疫原性的国际多中心、随机、双盲、安慰剂对照的III期临床试验 |
Public title: |
Efficacy, safety and immunogenicity of a recombinant protein subunit vaccine (CHO cells) against COVID-19 in adults: an international multicenter, randomized, double-blind, placebo-controlled phase III study |
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: |
评价重组新型冠状病毒疫苗(CHO细胞)在18周岁及以上成年人中的保护效力、安全性和免疫原性的国际多中心、随机、双盲、安慰剂对照的III期临床试验 |
Scientific title: |
Efficacy, safety and immunogenicity of a recombinant protein subunit vaccine (CHO cells) against COVID-19 in adults: an international multicenter, randomized, double-blind, placebo-controlled phase III study |
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: |
魏文进 |
研究负责人: |
黄婷 |
Applicant: |
Wei Wenjin |
Study leader: |
Huang Ting |
申请注册联系人电话: Applicant telephone: |
+86 18911290589 |
研究负责人电话: Study leader's telephone: |
+86 13330993324 |
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: |
weiwenjin66@126.com |
研究负责人电子邮件: Study leader's E-mail: |
cocoht@163.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: |
天津市北辰区淮河道12号 |
研究负责人通讯地址: |
四川省成都市武侯区中学路6号 |
Applicant address: |
38 Huaihe Road, Beichen District, Tianjin |
Study leader's address: |
6 Zhongxue Road, Wuhou District, Chengdu, Sichuan |
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: |
中逸安科生物技术股份有限公司 |
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Applicant's institution: |
ZHONGYIANKE Biotech 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: |
SC-0820212101 |
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: |
四川省疾病预防控制中心疫苗临床试验伦理委员会 |
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Name of the ethic committee: |
Vaccine Clinical Trial Ethics Committee of Sichuan Center for Disease Control and Prevention |
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伦理委员会批准日期: Date of approved by ethic committee: |
2021-08-24 | ||
伦理委员会联系人: |
张骥 |
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Contact Name of the ethic committee: |
Zhang Ji |
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伦理委员会联系地址: |
四川省成都市武侯区中学路6号 |
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Contact Address of the ethic committee: |
6 Zhongxue Road, Wuhou District, Chengdu, Sichuan |
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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: |
四川省疾病预防控制中心 |
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Primary sponsor: |
Sichuan Center for Disease Control and Prevention |
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研究实施负责(组长)单位地址: |
四川省成都市武侯区中学路6号 |
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Primary sponsor's address: |
6 Zhongxue Road, Wuhou District, Chengdu, Sichuan |
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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-funded |
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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: |
评价18周岁及以上成年人按0/28/56天免疫程序接种重组新型冠状病毒疫苗(CHO细胞)的保护效力、安全性和免疫原性。 |
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Objectives of Study: |
To evaluate the efficacy, safety and immunogenicity of a recombinant protein subunit vaccine (CHO cells) against COVID-19 in adults aged 18 years and older following a 0/28/56-day regimen. |
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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. 年龄在18周岁以上的成年人,性别不限; 2. 能够理解并自愿签署知情同意书; 3. 经查问病史、体检和临床判定为健康或医学状况稳定。医学状况稳定定义为入组前3个月内不存在因疾病恶化导致治疗发生显著改变或住院; 4. 育龄期女性在接种前的妊娠试验结果呈阴性;且自愿同意从签署知情同意书开始至研究结束期间采取有效的避孕措施(有效的避孕措施包括:口服避孕药(不包括紧急避孕药)、注射或埋置避孕、缓释局部避孕药、激素贴剂、宫内节育器、绝育、禁欲、安全套(男性)、隔膜、宫颈帽等)。 |
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Inclusion criteria |
1. Subjects aged 18 years and older; 2. Subjects capable of understanding and voluntarily signing the informed consent; 3. Subjects with general good health as judged by medical history and physical examination. General good health was defined as no significant change of treatment or hospitalization due to disease deterioration within 3 months prior to enrollment; 4. Women of childbearing age presented with a negative pregnancy test result prior to vaccination, and who voluntarily agree to take effective contraceptive measures (including: oral contraceptives (excluding emergency contraceptives), injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices, sterilization, abstinence, condoms (male), diaphragms, cervical caps, etc.) from the time of signing the informed consent until the end of the study. |
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排除标准: |
1. 有COVID-19病史,或筛选时SARS-CoV-2核酸和抗体检测其中之一阳性者(仅中国以外地区); 2. 入组前72小时内怀疑或确诊发热(腋温≥37.3℃/口温≥37.5℃),或入组当天腋下体温≥37.3℃/口温≥37.5℃; 3. 有严重急性呼吸综合征(SARS)、中东呼吸综合征(MERS)等人冠状病毒感染史或疾病史; 4. 任何确诊或疑似免疫抑制或免疫缺陷状态,已知的HIV感染史、无脾或功能性无脾; 5. 存在严重或不可控或需住院治疗的心血管疾病、糖尿病、神经系统疾病(如格林巴利综合征)、血液和淋巴系统疾病、免疫系统疾病、肝肾疾病、呼吸系统疾病(如活动性结核、肺纤维化)、代谢及骨骼等系统疾病,或恶性肿瘤; 6. 近3天内各种急性疾病或慢性疾病急性发作; 7. 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,或需要持续使用抗凝药; 8. 既往有严重过敏史(包括药物和疫苗),或对试验疫苗的任何成分,包括铝制剂有严重过敏史,例如:过敏性休克、过敏性喉头水肿、过敏性紫癜、血小板减少性紫癜、局部过敏坏死反应(Arthus反应)、呼吸困难、血管神经性水肿等; 9. 有新型冠状病毒疫苗接种史(含附条件批准/紧急使用疫苗和试验疫苗); 10. 试验疫苗接种前3个月内注射过免疫球蛋白和/或其他血液制品; 11. 试验疫苗接种前28天内接受过减毒活疫苗,或接种前14天内接受过亚单位或灭活疫苗; 12. 曾参与或研究期间参加任何其他COVID-19预防性药物试验(注:如果因COVID-19住院,则允许参加COVID-19治疗试验,应尽快通知研究团队); 13. 过去6个月内长期使用(连续使用>14天)糖皮质激素(剂量≥20 mg/天,强的松或相当剂量)或其他免疫抑制剂,但以下情况允许入组:允许吸入或局部使用外用类固醇,或短期使用(疗程≤14天)口服类固醇; 14. 哺乳期女性; 15. 可疑或已知的严重酒精(酗酒)或药物依赖; 16. 可能影响试验参与情况的精神病史,精神病家族史; 17. 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(影响预定访视时间)离开本地; 18. 研究者认为不适宜参加试验的其他情况。 |
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Exclusion criteria: |
1. History of COVID-19, or positive results for either SARS-CoV-2 nucleic acid and antibody tests at screening (outside China only); 2. Suspected or confirmed fever (axillary temperature >= 37.3 degrees/oral temperature >= 37.5 degrees) within 72 hours prior to or on the day of enrollment; 3. History of human coronavirus infection/diseases, such as severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS); 4. Any confirmed or suspected immunosuppression or immunodeficiency status, known history of HIV infection, absence or functional absence of spleen caused by any condition; 5. Presence of severe, uncontrollable or hospitalized cardiovascular diseases, diabetes, neurological diseases (e.g., Green-Barry syndrome), blood and lymphatic diseases, immune diseases, liver and kidney diseases, respiratory diseases (e.g., active tuberculosis, pulmonary fibrosis), metabolic and skeletal diseases, or malignant tumors; 6. Any acute diseases or acute attacks of chronic diseases 3 days prior to enrollment; 7. Genetic predisposition of bleeding, or history of coagulation disorders, thrombotic or bleeding disorders, or conditions that needs continuous anticoagulant usage; 8. History of severe allergy to drugs and vaccines, or to any component of the test vaccine (including the aluminum adjuvant), such as anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, Arthus reaction, dyspnea, angioneurotic edema, etc.; 9. Receipt of any SARS-COV-2 vaccine (including conditional approved/emergency use authorized vaccines or experimental vaccines); 10. Receipt of immunoglobulin and/or other blood products within 3 months prior to vaccination; 11. Receipt of live attenuated vaccine within 28 days prior to vaccination and other vaccines within 14 days prior to vaccination; 12. Previously or currently participation of any other COVID-19 prophylactic drug trials during the study (if subjects underwent hospitalization owning to COVID-19, participation in a treatment trial is permitted, but should notify the investigators immediately); 13. Long-term receipt (> 14 consecutive days) of glucocorticoid (reference value for dose: >= 20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 6 months, with exception of inhaled or topical corticosteroids, or short-term use (<= 14 consecutive days) of oral corticosteroids; 14. Lactating females; 15. Suspected or known history of severe alcohol (alcoholism) or drug dependence; 16. History or family history of psychiatric illness that may affect trial outcomes; 17. Planned permanent relocation from the study sites during the study or prolonged absence from the local area (affecting the scheduled visit time) during the study visits; 18. Other circumstances which the investigator considers inappropriate for participating in the trial. |
研究实施时间: Study execute time: |
从From2021-09-02至To |
征募观察对象时间: Recruiting time: |
从From2021-09-02至To |
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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