注册号: Registration number: |
ChiCTR2000039994 |
最近更新日期: Date of Last Refreshed on: |
2021-02-22 |
注册时间: Date of Registration: |
2020-11-17 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
重组新型冠状病毒肺炎(COVID-19)疫苗(Sf9)II期临床试验研究 |
Public title: |
Recombinant COVID-19 Vaccine (Sf9 cells) Phase II Clinical Trial |
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: |
在18周岁及以上健康成年和老年受试者中开展重组新型冠状病毒肺炎疫苗(Sf9细胞)的单中心、随机、双盲、安慰剂对照的Ⅱ期临床试验 |
Scientific title: |
A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, Phase II Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 cells), in Healthy Adults Aged 18 Years and Above |
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: |
王玮 |
研究负责人: |
朱凤才 |
Applicant: |
Wei Wang |
Study leader: |
Fengcai Zhu |
申请注册联系人电话: Applicant telephone: |
+86 13679077022 |
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: |
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申请注册联系人电子邮件: Applicant E-mail: |
weiwang@scu.edu.cn |
研究负责人电子邮件: Study leader's E-mail: |
jszfc@jscdc.cn |
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: |
中国四川省成都市武侯区国学巷37号 |
研究负责人通讯地址: |
江苏省南京市江苏路172号 |
Applicant address: |
37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China |
Study leader's address: |
172 Jiangsu Road, 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: |
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申请人所在单位: |
四川大学华西医院 |
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Applicant's institution: |
West China Hospital, Sichuan University |
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: |
JSJK2020-A065-01 |
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 |
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Name of the ethic committee: |
Ethics Committee of Jiangsu Provincial Center for Disease Prevention and Control |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-11-16 | ||
伦理委员会联系人: |
蔡慧媛 |
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Contact Name of the ethic committee: |
Huiyuan Cai |
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伦理委员会联系地址: |
江苏省南京市江苏路172号 |
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Contact Address of the ethic committee: |
172 Jiangsu Road, Nanjing, Jiangsu, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 25-83759406 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
ec@jscdc.cn |
研究实施负责(组长)单位: |
四川大学华西医院 |
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Primary sponsor: |
West China Hospital, Sichuan University |
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研究实施负责(组长)单位地址: |
成都市武侯区国学巷37号 |
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Primary sponsor's address: |
37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China |
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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: |
no funding |
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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: |
II期临床试验 | ||||||||||||||||||||||
Study phase: |
2 |
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研究目的: |
评价18周岁及以上健康成年和老年受试者(年龄≥18岁且<60岁以及≥60岁且≤85岁)按不同免疫程序(0、21天和0、14、28天)接种不同剂量(20μg、40μg)重组新型冠状病毒肺炎疫苗(Sf9细胞)的免疫原性和安全性。 |
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Objectives of Study: |
To evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in healthy adults and elderly (aged 18-60 and 60-85 years) with different immune procedure (0, 21 days or 0, 14, 28 days). |
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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周岁及以上。 2.获得受试者的知情同意,并签署知情同意书。 3.受试者能够并愿意遵守临床试验方案的要求,并且能完成约6个月的研究随访。 4.腋下体温≤37.0℃。 5.经查问病史、体检和临床判定健康者,符合本制品免疫接种的受试者。 |
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Inclusion criteria |
1. Aged 18 years and above; 2. Able to understand the content of informed consent and willing to sign the informed consent; 3. Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months); 4. Axillary temperature <= 37.0 degree C; 5. General good health as established by medical history and physical examination. |
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排除标准: |
1.2019新型冠状病毒抗体(IgG和IgM)筛查阳性。 2.已知的HIV感染史。 3.有惊厥、癫痫、脑病和精神病等病史或家族史者。 4.对研究疫苗中任何成份过敏者,过去有较严重的疫苗过敏反应,过敏史。 5.女性尿妊娠试验阳性者,怀孕、在哺乳期的妇女,或在6个月内有怀孕计划的妇女。 6.急性发热性疾病者及传染病者。 7.有SARS病史者。 8.患有较严重的心血管疾病,如心律失常、传导阻滞、心肌梗塞、严重高血压且药物无法控制等。 9.患有严重慢性疾病或病情处于进展期不能平稳控制,如哮喘、糖尿病、甲状腺疾病等。 10.先天或获得性的血管性水肿/神经性水肿。 11.接受试验疫苗前1年有患荨麻疹。 12.无脾或功能性无脾。 13.患血小板减少症或其他凝血障碍(可能造成肌肉注射禁忌)。 14.晕针者。 15.过去6个月内有过免疫抑制剂治疗、抗过敏治疗、细胞毒性治疗、吸入皮质类固醇(不包括过敏性鼻炎的皮质类固醇喷雾治疗,急性非并发皮炎的表面皮质类固醇治疗)。 16.接受试验疫苗前4个月内接受过血液制品。 17.接受试验疫苗前1个月内接受过其他研究药物。 18.接受试验疫苗前1个月内接受过减毒活疫苗。 19.接受试验疫苗前14天内接受过亚单位或灭活疫苗。 20.正在接受抗结核治疗。 21.根据研究者判断,由于各种医疗、心理、社会条件或其他条件,有悖于试验方案,或影响受试者签署知情同意的。 |
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Exclusion criteria: |
1. Positive serum IgM and IgG to the SARS-CoV-2; 2. History of HIV infection 3. Family history of seizure, epilepsy, brain or mental disease. 4. Participant that has an allergic history to any ingredient of vaccines; 5. oman who is pregnant, breast-feeding or positive in pregnancy test on day of enrollment, or is planning to be pregnant during the next 6 months; 6. Any acute fever disease or infections; 7. Have a medical history of SARS; 8. Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and not well-controlled; 9. Major chronic illness, such as asthma, diabetes, or thyroid disease, and not well-controlled; 10. Hereditary angioneurotic edema or acquired angioneurotic edema; 11. Urticaria in last one year; 12. Asplenia or functional asplenia; 13. Platelet disorder or other bleeding disorder may cause injection contraindication; 14. Faint at the sight of blood or needles; 15. Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months; 16. Prior administration of blood products in last 4 months; 17. Prior administration of other research medicines in last 1 month; 18. Prior administration of attenuated vaccine in last 1 month; 19. Prior administration of subunit vaccine or inactivated vaccine in last 14 days; 20. Being treated for tuberculosis; 21. Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives. |
研究实施时间: Study execute time: |
从From2020-11-17至To 2021-11-18 |
征募观察对象时间: Recruiting time: |
从From2020-11-17至To 2020-12-18 |
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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