注册号: Registration number: |
ChiCTR2000039462 |
最近更新日期: Date of Last Refreshed on: |
2021-01-30 |
注册时间: Date of Registration: |
2020-10-28 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
新型冠状病毒(COVID-19)灭活疫苗(Vero细胞)Ⅱ期临床试验 |
Public title: |
A phase II clinical trial for inactivated SARS-CoV-2 (COVID-19) Vaccine (Vero Cells) |
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: |
评价新型冠状病毒灭活疫苗(Vero细胞)在18岁及以上健康人群中免疫的安全性和免疫原性的随机、双盲、安慰剂对照Ⅱ期临床试验 |
Scientific title: |
Evaluation of the safety and immunogenicity of inactivated SARS-CoV-2 Vaccine (Vero Cells) in healthy population aged 18 years and above: a randomized, double-blind, placebo parallel-controlled phase II clinical trial |
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: |
李贵凡 |
研究负责人: |
潘红星 |
Applicant: |
Li Guifan |
Study leader: |
Pan Hongxing |
申请注册联系人电话: Applicant telephone: |
+86 010-59613591 |
研究负责人电话: Study leader's telephone: |
+86 025-83759903 |
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: |
guifan@sohu.com |
研究负责人电子邮件: Study leader's E-mail: |
panhongxing@126.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: |
北京市大兴区中关村科技园区大兴生物医药产业基地思邈路35号 |
研究负责人通讯地址: |
江苏省南京市江苏路172号 |
Applicant address: |
35 Simiao Road, Bio-Medicine Industry Park, Daxing District, Beijing, 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: |
深圳康泰生物制品股份有限公司,北京民海生物科技有限公司 |
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Applicant's institution: |
Shenzhen Kangtai Biological Products Co.,Ltd.; Beijing Minhai Biotechnology 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: |
JSJK2020-A058-02 |
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: |
Ethic Committee of Jiangsu Provincial 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: |
2020-09-30 | ||
伦理委员会联系人: |
蔡慧媛 |
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Contact Name of the ethic committee: |
Cai Huiyuan |
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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: |
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) |
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Primary sponsor: |
Jiangsu Provincial Center for Disease Control and Prevention (Public Health Research Institute of Jiangsu Province) |
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研究实施负责(组长)单位地址: |
江苏省南京市江苏路172号 |
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Primary sponsor's address: |
172 Jiangsu Road, Nanjing, Jiangsu, 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: |
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: |
II期临床试验 | ||||||||||||||||||||||||||||||||||||||||||||
Study phase: |
2 |
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研究目的: |
评价新型冠状病毒灭活疫苗(Vero细胞)在18岁及以上健康人群中免疫的安全性和免疫原性。 |
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Objectives of Study: |
To evaluate the safety and immunogenicity of inactivated SARS-CoV-2 Vaccine(Vero Cells) in healthy people aged 18 years and above |
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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岁及以上常住健康人群; 2.获得志愿者的同意,并签署知情同意书; 3.志愿者能遵守临床试验方案的要求; 4.腋下体温≤37.0℃者; 5.育龄女性受试者入组时没有怀孕、未在哺乳期且在入组后的前3个月内无生育计划;在入选前2周内已采取有效的避孕措施。 |
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Inclusion criteria |
1. Healthy permanent residents aged 18 years and above; 2. Subjects agree to sign the informed consent forms voluntarily; 3. Subjects are able to comply with the requirements of the clinical trial protocol; 4. Armpit temperature <= 37.0 degrees C; 5. Female subjects of childbearing age were not pregnant at the time of enrollment, were not breastfeeding, and had no birth plan within the first 3 months after enrollment; effective contraceptive measures had been taken within 2 weeks before enrollment. |
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排除标准: |
1.接种前14天内去过境外及出现过疫情的村/社区,接触新型冠状病毒感染者或疑似病例,处于隔离期内的人员,或同村/社区内出现新型冠状病毒感染者或疑似病例; 2.新型冠状病毒感染确诊病例、疑似病例者或无症状感染者(查询中国疾病预防控制信息系统); 3.自我报告有SARS病毒感染史; 4.咽拭子RT-PCR检测结果为阳性; 5.新型冠状病毒抗体检测阳性; 6.既往发生过疫苗接种严重过敏反应(如急性过敏反应、荨麻疹、皮肤湿疹、呼吸困难、血管神经性水肿或腹痛)或对新型冠状病毒灭活疫苗已知成份过敏; 7.有惊厥、癫痫、脑病或精神疾病史或家族史; 8.先天畸形或发育障碍,遗传缺陷,严重营养不良等; 9.已知或怀疑患有疾病包括:严重呼吸系统疾病、严重心血管疾病、严重的肝肾疾病、药物不可控制的高血压(收缩压≥140mmHg,舒张压≥90 mmHg;≥60岁受试者收缩压≥150mmHg,舒张压≥100 mmHg )、糖尿病并发症、恶性肿瘤、各种急性疾病或慢性疾病急性发作期; 10.已被诊断为患有先天性或获得性免疫缺陷、HIV感染、淋巴瘤、白血病或其他自身免疫疾病; 11.有凝血功能异常史(如凝血因子缺乏,凝血性疾病); 12.正在接受抗结核治疗; 13.接种前6个月内接受过其他研究药物; 14.接种前3个月内接受免疫增强或抑制剂治疗者(持续口服或滴注超过14天); 15.接种前3个月内接受过血液制品; 16.接种前14天内接种过减毒活疫苗; 17.接种前7天内接种过其他疫苗; 18.研究者判断其他不适合参加本临床试验的情况。 |
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Exclusion criteria: |
1. Within 14 days before vaccination, subjects have been abroad and to villages/communities experienced COVID-19 epidemics, and in contact with COVID-19 cases or suspected cases. Subjects are under isolation observation, or living in the villages/communities with COVID-19 cases or suspected cases; 2. Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control); 3. Subjects with history of SARS virus infection by self-reported; 4. Positive in throat swab through RT-PCR; 5. Positive in SARS-CoV-2 antibody test; 6. Subjects with history of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated SARS-CoV-2 vaccine; 7. Subjects with history of convulsion, epilepsy, encephalopathy or mental illness or family history; 8. Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; 9. Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, uncontrollable hypertension (systolic pressure >=140 mmHg, diastolic pressure >= 90 mmHg; subjects aged >= 60 years with systolic pressure >=150 mmHg, diastolic pressure >=100 mmHg), diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases; 10. Subjects diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; 11. Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease); 12. Subjects receiving anti-TB treatment; 13. Subjects receiving other research drugs within 6 months before vaccination; 14. Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days); 15. Subjects receiving blood products within 3 months before administration; 16. Subjects vaccinated with live attenuated vaccine within 14 days before vaccination; 17. Subjects vaccinated with other vaccine within 7 days before vaccination; 18. The researchers shall judge the other conditions which might be not in compliance with the reequipments of this clinical trial. |
研究实施时间: Study execute time: |
从From2020-10-27至To 2022-04-26 |
征募观察对象时间: Recruiting time: |
从From2020-10-27至To 2021-12-31 |
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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