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A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding Clinical Trial to Evaluate the Safety and Immunogenicity of Different Doses of COVID-19 DNA Vaccine INO-4800 Administered Intradermally Followed by Electroporation in Healthy Adult and Elderly Volunteers
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注册号:

Registration number:

ChiCTR2000040146 

最近更新日期:

Date of Last Refreshed on:

2021-01-29 

注册时间:

Date of Registration:

2020-11-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项随机、双盲、安慰剂对照评估在健康成年及老年受试者中皮内注射不同剂量新型冠状病毒肺炎(COVID-19)DNA疫苗INO-4800并进行电脉冲的安全性和免疫原性的II期剂量探索临床研究 

Public title:

A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding Clinical Trial to Evaluate the Safety and Immunogenicity of Different Doses of COVID-19 DNA Vaccine INO-4800 Administered Intradermally Followed by Electroporation in Healthy Adult and Elderly Volunteers 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型冠状病毒肺炎预防性DNA疫苗II期临床试验 

Scientific title:

COVID-19 DNA vaccine phase II clinical trial 

研究课题代号(代码):

Study subject ID:

 

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:

怀雪芬 

研究负责人:

朱凤才 

Applicant:

Xuefen Huai 

Study leader:

Fengcai Zhu 

申请注册联系人电话:

Applicant telephone:

+86 18351991682 

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:

 

申请注册联系人电子邮件:

Applicant E-mail:

xuefenhuai@advaccine.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):

 

申请注册联系人通讯地址:

苏州工业园区星湖街218号生物纳米园B1栋308 

研究负责人通讯地址:

江苏省南京市江苏路 172 号 A 楼 330 室 

Applicant address:

Room 308, Building B1, 218 Xinghu Street, Suzhou Industrial Park, China 

Study leader's address:

172 Jiangsu Road, Nanjing, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

215000 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

艾棣维欣(苏州)生物制药有限公司 

Applicant's institution:

Advaccine (Suzhou) Biopharmaceutical.,Ltd. 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

JSJK2020-A063-02 

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 

Name of the ethic committee:

Ethics Committee of Jiangsu Provincial Center for Disease Control and Prevention 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-11-06 

伦理委员会联系人:

蔡慧媛 

Contact Name of the ethic committee:

Huiyuan Cai 

伦理委员会联系地址:

江苏省南京市江苏路 172 号 

Contact Address of the ethic committee:

172 Jiangsu Road, Nanjing, Jiangsu, China 

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 

Primary sponsor:

Jiangsu Provincial Center for Disease Control and Prevention 

研究实施负责(组长)单位地址:

江苏省南京市江苏路 172 号 

Primary sponsor's address:

172 Jiangsu Road, Nanjing, Jiangsu, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

江苏

市(区县):

苏州

Country:

China

Province:

Jiangsu

City:

Suzhou

单位(医院):

艾棣维欣(苏州)生物制药有限公司

具体地址:

苏州工业园区星湖街218号生物纳米园B1栋308

Institution
hospital:

Advaccine (Suzhou) Biopharmaceutical, Ltd.

Address:

Room 308, Building B1, 218 Xinghu Street, Suzhou Industrial Park

经费或物资来源:

申办方 

Source(s) of funding:

Sponosor 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19)  

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

II期临床试验 

Study phase:

研究目的:

主要目的: 1.评估不同剂量INO-4800在健康成年以及老年(年龄≥18岁且<60岁以及≥60岁且≤85岁)受试者中的安全性和耐受性; 2.评估不同剂量INO-4800在健康成年以及老年(年龄≥18岁且<60岁以及≥60岁且≤85岁)受试者中的体液免疫应答。 次要目的: 1.评估不同剂量INO-4800在健康成年以及老年(年龄≥18岁且<60岁以及≥60岁且≤85岁)受试者中的免疫应答持久性。 探索性目的: 2.评估不同剂量INO-4800在健康成年以及老年(年龄≥18岁且<60岁以及≥60岁且≤85岁)受试者中的细胞免疫应答。 

Objectives of Study:

Primary objectives: 1. To evaluate the safety and tolerability of INO-4800 at different dose levels in healthy subjects (>= 18 and < 60 years old as well as >= 60 and <= 85 years old); 2. To evaluate the humoral immune response of INO-4800 at different doses in healthy subjects (>= 18 and < 60 years old as well as >= 60 and <= 85 years old). Secondary objective: 3. To evaluate the duration of humoral response of INO-4800 at different doses in healthy subjects at different ages ((>= 18 and < 60 years old as well as >= 60 and <= 85 years old). Exploratory objective: 4. To evaluate the cellular immune response of INO-4800 at different doses in healthy subjects ((>= 18 and < 60 years old as well as >= 60 and <= 85 years old). 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 年龄≥18岁且<60岁,性别不限(仅限成年受试者); 2. 年龄≥60岁且≤85岁,性别不限(仅限老年受试者); 3. 体重指数(BMI)介于18~35 kg/m2(含上下限); 4. 疫苗接种当天腋温<37.3 ℃; 5. 经询问病史、检查体检结果,经研究者判定为符合本制品免疫接种的健康受试者; 6. 自愿参加本临床试验,能够正确理解并签署书面知情同意书; 7. 能够配合研究人员,遵守研究方案要求,并按照方案相关程序完成检查;同意在研究期间遵守研究方案规定的生活方式(出国、出差、旅游等限制)。 

Inclusion criteria

1. Aged 18 to 60 years old, male or female (for adult subjects only); 2. Aged 60 to 85 years old, male or female (for elderly subjects only); 3. Body mass index (BMI) of 18-35 kg/m2 (inclusive); 4. Axillary temperature < 37.3 degrees C on the day of vaccination; 5. Subjects are considered by the investigator as healthy subjects eligible for immunization with this product based on inquiry of medical history and inspection of the physical examination results; 6. Subjects volunteer to participate in this clinical trial, and are able to correctly understand and sign the written Informed Consent Form (ICF); 7. Subjects can cooperate with the investigator, observe the requirements of the protocol, and complete the examinations according to relevant procedures in the protocol; agree to abide by the mode of life stipulated in the protocol (restrictions on overseas trips, business trips or travel) during the study period. 

排除标准:

1. 新型冠状病毒抗体检测阳性 2. 既往已经确诊感染SARSMERS病毒者。 3. 接种疫苗前2周内急性感染者。 4. 有晕针史者。 5. 在计划注射部位20 cm范围内有金属植入物者。 6. 在计划注射部位存在纹身、瘢痕瘤形成或增生性瘢痕者。 7. 植入心脏起搏器或自动植入式心律转复除颤器(AICD)者。 8. 任何预激综合征及病史者,例如沃夫巴金森怀特症候群(Wolff-Parkinson-White syndrome)综合征。 9. 尿妊娠检测阳性的女性受试者,怀孕/哺乳期妇女,或在12个月内有妊娠计划妇女(适用于<60岁育龄女性受试者)。 10. 患有导致免疫缺陷或免疫抑制的疾病,如先天性免疫缺陷、恶性血液肿瘤(白血病、淋巴瘤)等,进行器官移植和骨髓移植者。 11. 有过敏性疾病患者或过敏体质(如有血管性水肿/神经性水肿或荨麻疹病史)者。 12. 既往接种任何疫苗曾出现过严重过敏反应或已知对本品或其制剂成分(DNA质粒、柠檬酸钠等)过敏者。 13. 曾患或现患有具有临床意义的心血管(除药物能控制的高血压)、呼吸、肝脏(除轻度脂肪肝)、肾脏、胃肠道(除慢性胃炎)、内分泌、血液学或神经系统疾病,经研究者判断可能影响研究评估;或在接种研究疫苗期间造成风险;或干扰数据的解释。排除的病症示例包括但不限于:冠心病、心绞痛、心力衰竭、心肌病、慢性阻塞性肺气肿、肺纤维化、哮喘、肝炎、肝硬化、肾功能损害、糖尿病、贫血、脑血管疾病、癫痫、精神分裂症等。 14. 既往有精神病史者。 15. 接种研究疫苗前4周内接受过手术或化疗,或者计划在研究期间进行手术者。 16. 接种研究疫苗前12周内接受过血液制品(如免疫球蛋白)、研究性药物/器械,或者计划在研究期间使用者。 17. 接种研究疫苗前4周内接种过其他疫苗。 18. 服用药物导致的免疫抑制,包括: ? 长期使用(≥7天)口服或胃肠外糖皮质激素(不包括局部皮肤和/或含滴眼液的皮质类固醇、低剂量甲氨蝶呤或剂量低于20 mg/天的皮质类固醇); ? 目前或预期使用缓解病情剂量的抗风湿药(如硫唑嘌呤、环磷酰胺、环孢菌素、甲氨蝶呤)和生物疾病缓解药物如TNF-α抑制剂(如英夫利西单抗、阿达木单抗或依那西普); ? 其它可能危及受试者安全、可能干扰研究评估或终点评价,或以其他方式影响研究结果的有效性的其他具有临床意义的免疫抑制。 19. 有药物滥用史者。 20. 接种当天饮酒超过14个标准单位。1标准单位含14g酒精,如360 mL啤酒或45 mL酒精量为40%的烈酒或150 mL葡萄酒。 21. 接种研究疫苗前3个月内献血或大量失血超过400mL或研究期间有计划献血者。 22. 脾脏异常或功能性无脾病史。 23. 其它研究者认为有不适合参加研究的其他因素者。 

Exclusion criteria:

1. Positive test result for SARS-CoV-2 (IgG and IgM) testing; 2. Those with confirmed infection with SARS or MERS virus previously; 3. Those with an acute infection within 2 weeks before vaccination; 4. Those with a history of needle sickness; 5. Those with a metal implant within 20 cm from the planned injection site; 6. Those with a tattoo, keloid formation or hypertrophic scar at the planned injection site; 7. Those implanted with cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD); 8. Those with any pre-excitation syndrome or relevant history, e.g. Wolff-Parkinson-White syndrome; 9. Female subjects with a positive result of urine pregnancy test, pregnant/lactating women, or women planning to be pregnant within 12 months (for women of childbearing potential aged < 60 years old); 10. Those undergoing organ transplantation or bone marrow transplantation due to diseases that may cause immunodeficiency or immunosuppression, e.g. congenital immunodeficiency and malignant blood tumors (leukemia and lymphoma); 11. Those with allergic disease or allergic constitution (e.g. with history of angioedema/neuroedema or urticaria); 12. Those with a history of serious allergic reaction or known to be allergic to this product or components in its preparation (e.g. DNA plasmid and sodium citrate); 13. Those who previously suffered or currently suffer from clinically significant cardiovascular (except hypertension that can be controlled by drugs), respiratory, hepatic (except mild fatty liver), renal, gastrointestinal (except chronic gastritis), endocrine, hematological or nervous system diseases that may affect the study evaluation as assessed by the investigators; or cause risks during the vaccination of the investigational vaccine; or interfere with the interpretation of data. Examples of excluded conditions include but are not limited to: coronary heart disease, angina pectoris, heart failure, cardiomyopathy, chronic obstructive pulmonary emphysema, pulmonary fibrosis, asthma, hepatitis, cirrhosis, renal impairment, diabetes mellitus, anemia, cerebrovascular disease, epilepsy, schizophrenia, etc. [31]; 14. Those with psychiatric history; 15. Those who have undergone surgery or chemotherapy within 4 weeks before inoculation of the investigational vaccine, or who plan to undergo a surgery during the study period; 16. Those who have received blood products (e.g., immunoglobulin), investigational drugs/devices within the 12 weeks before inoculation of the investigational vaccine, or plan to use them during the study period; 17. Those who have received another vaccine within 4 weeks before inoculation of the investigational vaccine; 18. Those with immunosuppression effects caused by drug use, including: (1) Long-term use (>=7 days) of oral or parenteral glucocorticoids (excluding topical corticosteroids, and/or corticosteroids containing eye drops, low-dose methotrexate, or corticosteroids with a dose less than 20 mg/day); (2) Those who are using or are expected to use antirheumatic drugs (e.g. azathioprine, cyclophosphamide, cyclosporin, and methotrexate) and biological drugs for disease alleviation, e.g. TNF-α inhibitors (e.g., infliximab, adalimumab, or etanercept); (3) Those with other immunosuppression effects of clinical significance that may affect the safety of subjects, interfere with the study assessment or endpoint evaluation, or otherwise affect the validity of the study results; 19. Those with history of drug abuse; 20. Those who drink more than 14 standard units of alcohol on the day of vaccination. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer, or 45 mL of spirits containing 40% alcohol, or 150 mL of wine; 21. Those who have had blood donation or massive blood loss of more than 400 mL within 3 months before inoculation of the investigational vaccine or have a plan of blood donation during the study period; 22. Those with a history of abnormal spleen or functional absence of spleen; 23. Those with other factors considered by the investigator to be unsuitable for participating in the study. 

研究实施时间:

Study execute time:

From2020-12-02To 2021-01-31 

征募观察对象时间:

Recruiting time:

From2020-12-02To 2021-01-31 

干预措施:

Interventions:

组别:

A1 成年组

样本量:

160

Group:

A1 Adult group

Sample size:

干预措施:

试验疫苗 INO-4800 1.0 mg/安慰剂

干预措施代码:

Intervention:

INO-4800 1.0 mg / placebo

Intervention code:

组别:

A2 老年组

样本量:

160

Group:

A2 Elderly group

Sample size:

干预措施:

试验疫苗 INO-4800 1.0 mg/安慰剂

干预措施代码:

Intervention:

INO-4800 1.0 mg / placebo

Intervention code:

组别:

B1 成年组

样本量:

160

Group:

B1 Adult group

Sample size:

干预措施:

试验疫苗 INO-4800 2.0 mg/安慰剂

干预措施代码:

Intervention:

INO-4800 2.0 mg/ placebo

Intervention code:

组别:

B2 老年组

样本量:

160

Group:

B2 Elderly group

Sample size:

干预措施:

试验疫苗 INO-4800 2.0 mg/安慰剂

干预措施代码:

Intervention:

INO-4800 2.0 mg/ placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

丹阳市疾病预防控制中心 

单位级别:

N/A 

Institution
hospital:

Danyang City Center for Disease Control and Prevention  

Level of the institution:

N/A 

测量指标:

Outcomes:

指标中文名:

不良事件

指标类型:

主要指标 

Outcome:

Adverse events

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗 SARS-CoV-2 病毒 S 蛋白的特异性抗体(ELISA 法)的几何平均滴度

指标类型:

主要指标 

Outcome:

GMT of specific antibody against S protein of SARS-CoV-2

Type:

Primary indicator 

测量时间点:

第 2 剂疫苗接种后第 30 天

测量方法:

Measure time point of outcome:

30 days after the second dose of vaccine

Measure method:

指标中文名:

抗 SARS-CoV-2 病毒 S 蛋白的中和抗体(假病毒中和法)的几何平均滴度

指标类型:

主要指标 

Outcome:

GMT of neutralizing antibody against S protein of SARS-CoV-2

Type:

Primary indicator 

测量时间点:

第 2 剂疫苗接种后第 30 天

测量方法:

Measure time point of outcome:

30 days after the second dose of vaccine

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 85 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

由随机编盲团队完成随机化设定程序

Randomization Procedure (please state who generates the random number sequence and by what method):

The randomization program is completed by the randomization team

盲法:

双盲

Blinding:

Double blind

是否共享原始数据:

IPD sharing

Yes

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):

无 请阅读网页注册指南中关于“原始数据共享”的内容。

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:

EDC, CRF

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

EDC, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-11-22
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