审核状态: Project audit state: |
通过审核 Successful |
注册号: Registration number: |
ChiCTR2200057278 |
最近更新时间: Date of Last Refreshed on: |
2022/3/6 17:27:17 |
注册号状态: |
补注册 |
Registration Status: |
Retrospective registration |
填写语言: |
中文和英文 |
Language: |
Chinese And English |
注册题目: |
不同新型冠状病毒疫苗加强免疫后的免疫原性研究 |
Public title: |
Immunogenicity Study on Booster Immunization of different COVID-19 vaccines |
注册题目简写: |
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Public title acronym: |
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研究课题的正式科学名称: |
灭活疫苗、腺病毒载体新冠疫苗、重组蛋白新冠疫苗加强免疫后的免疫原性研究 |
Scientific title: |
Immunogenicity Study on Booster Immunization of Inactivated COVID-19 Vaccine, Ad5-vectored COVID-19 Vaccine and Recombinant Protein Subunit COVID-19 Vaccine |
研究课题的正式科学名称简写: |
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Scientific title acronym: |
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研究课题代号(代码): Study subject ID: |
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在其它机构的注册号: Secondary ID: |
申请注册联系人: |
侯利华 |
研究负责人: |
孙玉发 |
Applicant: |
Hou Lihua |
Study leader: |
Sun Yufa |
申请注册联系人电话: Applicant telephone: |
010-66948565 |
研究负责人电话: Study leader's telephone: |
010-63815273 |
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: |
houlihua@sina.com |
研究负责人电子邮件: Study leader's E-mail: |
dafa20136725@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: |
丰台区东大街20号 |
研究负责人通讯地址: |
北京市西城区府右街 |
Applicant address: |
No. 20 Dongdajie Street,Fengtai District, Beijing, China |
Study leader's address: |
Fuyou Street,Xicheng District,Beijing |
申请注册联系人邮政编码: Applicant postcode: |
100071 |
研究负责人邮政编码: Study leader's postcode: |
100035 |
申请人所在单位: |
军事科学院军事医学研究院生物工程研究所 |
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Applicant's institution: |
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China |
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: |
202201 |
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: |
中国人民解放军305医院医学伦理委员会 |
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Name of the ethic committee: |
Ethic Committee of 305 Hospitsal of PLA |
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伦理委员会批准日期: Date of approved by ethic committee: |
2022-01-06 | ||
国家FDA批准文号: Approved No. of SFDA: |
国家FDA批准附件: Approved file of SFDA: |
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国家FDA批准日期: Date of approved by SFDA: |
研究实施负责(组长)单位: |
中共中央办公厅警卫局保健处 |
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Primary sponsor: |
Health Service Department of the Guard Bureau of the General Office of the Central Committee of the Communist Party of China |
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研究实施负责(组长)单位地址: |
北京市西城区府右街 |
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Primary sponsor's address: |
Fuyou Street,Xicheng District,Beijing |
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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: |
国家科技部重点研发计划 |
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Source(s) of funding: |
Ministry of Science and Technology of China |
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研究疾病: |
新型冠状病毒病 |
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Target disease: |
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: |
IV期临床试验 | ||||||||||||||||||||||
Study phase: |
4 |
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研究目的: |
评价18至59周岁健康成人加强接种不同新冠疫苗的免疫原性 |
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Objectives of Study: |
Evaluation of immunogenecity of booster vaccination with different COVID-19 vaccines in healthy adults aged between 18 and 59 years. |
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研究设计: |
非随机对照试验 |
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Study design: |
Non randomized control |
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纳入标准: |
1. 18-59岁的健康受试者,至少6个月前接种过灭活新冠疫苗、Ad5载体疫苗或重组蛋白亚单位疫苗。 2.受试者可以提供知情同意书并签署知情同意书(ICF)。 3.受试者能够并愿意遵守本试验的要求,能够完成本研究的6个月随访。 4.身体健康,符合接种要求的人员 |
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Inclusion criteria |
1.Healthy subjects aged 18-59 years, who have been vaccinated with the inactive COVID-19 vaccine, Ad5-Vectored Vaccine or the recombinant protein subunit vaccine at least 6 months ago. 2.The subject can provide with informed consent and sign informed consent form (ICF). 3.The subjects are able to and willing to comply with the requirements of this trial and could complete the 6-month follow-up of the study. 4.Individuals who are in good health condition and meet the requirements of vaccination |
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排除标准: |
1.有惊厥、癫痫、脑病、精神病的病史或家族史。 2.对疫苗的任何成分过敏,或曾对疫苗有过敏史或严重反应史。 3.尿妊娠试验阳性、怀孕或哺乳的妇女,或有六个月内怀孕计划的妇女。 4.患有急性发热性疾病和传染病。 5.有严重的慢性病或病情无法控制。 6.先天性或后天性血管性水肿/神经性水肿。 7.过去6个月内有免疫抑制治疗、抗过敏治疗、细胞毒治疗或吸入糖皮质激素(不包括用于过敏性鼻炎的糖皮质激素喷雾治疗和无皮炎的急性糖皮质激素治疗)。 8.在注射研究疫苗前4个月内接受过血液制品。 9.接受抗结核治疗。 10.由于各种医学、心理、社会或其他条件,无法遵守方案,或根据研究者的判断无法理解知情同意书。 |
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Exclusion criteria: |
1.have the medical history or family history of convulsion, epilepsy, encephalopathy and psychosis. 2.be allergic to any component of the vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination. 3.women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months. 4.have acute febrile diseases and infectious diseases. 5.have severe chronic diseases or condition in progress cannot be controlled. 6.congenital or acquired angioedema / neuroedema. 7.have the history of immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy or inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and acute corticosteroid therapy without dermatitis) over the past 6 months. 8.have received blood products within 4 months before injection of investigational vaccines. 9.under anti-tuberculosis treatment. 10.not be able to follow the protocol, or not be able to understand the informed consent according to the investigator's judgment, due to various medical, psychological, social or other conditions. |
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研究实施时间: Study execute time: |
从From2021-12-20至To 2022-07-31 |
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: |
正在进行 Recruiting |
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): |
本研究不采用随机方法。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Randomization is not used in this study |
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UTN(全球唯一识别码): |
盲法: |
非盲态试验 |
Blinding: |
No blinding |
试验完成后的统计结果: |
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Calculated Results ater
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研究负责(组长)单位: |
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Organizer institution (leader institution): |
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资料收集汇总单位: |
0 |
Data collection Institution: |
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资料管理单位: |
No |
Data management Institution: |
No |
资料分析单位: |
No |
Data analysis Institution: |
No |