ChiCTR2600119810 版本V1.0 版本创建时间2026/03/04 08:43:29 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600119810 

最近更新日期：

Date of Last Refreshed on：

 2026-03-04 08:43:08 

注册时间：

Date of Registration：

 2026-03-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

重组带状疱疹疫苗(CHO细胞)在40周岁及以上人群中接种的安全性和免疫原性I期临床试验

Public title：

Phase I Clinical Trial on the Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cell) in Subjects Aged 40 Years and Above

注册题目简写：

English Acronym：

研究课题的正式科学名称：

重组带状疱疹疫苗(CHO细胞)在40周岁及以上人群中接种的安全性和免疫原性I期临床试验

Scientific title：

Phase I Clinical Trial on the Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cell) in Subjects Aged 40 Years and Above

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：

韩子晗 

研究负责人：

童叶青 

Applicant：

Zihan Han  

Study leader：

Yeqing Tong  

申请注册联系人电话：

Applicant telephone：

 +86 155 6744 6081

研究负责人电话：

Study leader's
telephone：

+86 139 7107 8410

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：

 hanzihan@parrbio.com

研究负责人电子邮件：

Study leader's E-mail：

 63382251@qq.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：

河北省石家庄市高新区昆仑南大街769号高新区生物医药产业园106号楼

研究负责人通讯地址：

湖北省武汉市洪山区卓刀泉北路35号

Applicant address：

Building 106, High-tech Bio-pharmaceutical Industrial Park, No.769 Kunlun South Street, High-tech Zone, Shijiazhuang City, Hebei Province

Study leader's address：

No.35, Zhuodaoquan North Road, Hongshan District, Wuhan City, Hubei Province

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：

申请人所在单位：

桓科(河北)生物技术有限公司

Applicant's institution：

HuanKe (Hebei) Biotechnology Co., Ltd.

研究负责人所在单位：

湖北省疾病预防控制中心

Affiliation of the Leader：

Hubei Provincial Center for Disease Control and Prevention

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：

 2026-001-01

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：

湖北省疾病预防控制中心（湖北省预防医学科学院）伦理审查委员会

Name of the ethic committee：

Ethical Review Committee of Hubei Provincial Center for Disease Control and Prevention (Hubei Academy of Preventive Medicine)

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-02-02 00:00:00

伦理委员会联系人：

沈恒

Contact Name of the ethic committee：

Heng Shen

伦理委员会联系地址：

湖北省武汉市洪山区卓刀泉北路35号

Contact Address of the ethic committee：

No.35, Zhuodaoquan North Road, Hongshan District, Wuhan City, Hubei Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 27 8765 2129

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：

湖北省疾病预防控制中心

Primary sponsor：

Hubei Provincial Center for Disease Control and Prevention

研究实施负责（组长）单位地址：

湖北省武汉市洪山区卓刀泉北路35号

Primary sponsor's address：

No.35, Zhuodaoquan North Road, Hongshan District, Wuhan City, Hubei Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

河北省

市(区县)：

Country：

China

Province：

Hebei

City：

单位(医院)：

桓科(河北)生物技术有限公司

具体地址：

河北省石家庄市高新区昆仑南大街769号高新区生物医药产业园106号楼

Institution
hospital：

HuanKe (Hebei) Biotechnology Co., Ltd.

Address：

Building 106, High-tech Bio-pharmaceutical Industrial Park, No.769 Kunlun South Street, High-tech Zone, Shijiazhuang City, Hebei Province

经费或物资来源：

申办者

Source(s) of funding：

Sponsor

研究疾病：

预防带状疱疹  

Target disease：

Prevention of herpes zoster

研究疾病代码：

Target disease code：

研究类型：

预防性研究

Study type：

Prevention

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的：评价重组带状疱疹疫苗（CHO细胞）在40周岁及以上人群中接种的安全性和耐受性。 次要目的：初步考察重组带状疱疹疫苗（CHO细胞）在40周岁及以上人群中接种的免疫原性。  

Objectives of Study：

Primary objective: To evaluate the safety and tolerability of recombinant varicella-zoster vaccine (CHO cell) in individuals aged 40 years and above. Secondary objective: To preliminarily investigate the immunogenicity of recombinant varicella-zoster vaccine (CHO cell) in individuals aged 40 years and above.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 年龄在40周岁及以上的男性或女性。 2. 能够充分理解并自愿签署知情同意书。 3. 经询问病史及相关体检，研究者临床判定符合试验用疫苗接种要求。 4. 能遵守临床试验方案的要求完成试验。 5. 入组当日腋下体温≤37.0℃。 6. 女性试验参与者需符合以下标准： 手术绝育或绝经后≥2年，或育龄女性（未绝经或绝经后<2年）妊娠检查呈阴性，且愿意从签署知情同意书开始至末次试验用疫苗接种后至少3个月内采取有效的物理避孕措施（如避孕套），不允许使用避孕药。 同意从签署知情同意书开始至末次试验用疫苗接种后至少3个月内不哺乳。 7. 男性试验参与者需符合以下标准： 如未进行绝育手术且发生可能导致怀孕的性行为，同意从签署知情同意书开始至完成全程免疫后至少3个月内采取有效的物理避孕措施（如避孕套）。

Inclusion criteria

1. Male or female participants aged 40 years or older. 2. Ability to fully understand and voluntarily sign the informed consent form. 3. Clinical assessment by investigators, based on medical history inquiry and relevant physical examinations, confirming eligibility for trial vaccine administration. 4. Compliance with the clinical trial protocol requirements for completing the trial. 5. Axillary body temperature <=37.0°C on the day of enrollment. 6. Female participants must meet the following criteria: undergone surgical sterilization or postmenopausal for >=2 years, or women of childbearing age (non-menopausal or postmenopausal for <2 years) with negative pregnancy test results, and willing to adopt effective physical contraception (e.g., condoms) from the date of signing the informed consent form until at least 3 months after the last trial vaccine administration; contraceptive pills are not permitted. Consent to abstain from breastfeeding from the date of signing the informed consent form until at least 3 months after the last trial vaccine administration. 7. Male participants must meet the following criteria: if not undergoing sterilization surgery and engaging in sexual activity that may result in pregnancy, agree to adopt effective physical contraception (e.g., condoms) from the date of signing the informed consent form until at least 3 months after completing the full immunization schedule.

排除标准：

1. 既往有疑似或诊断明确的带状疱疹病史； 2. 有水痘或带状疱疹疫苗接种史； 3. 入组前1年有水痘/带状疱疹病人接触史； 4. 对试验用疫苗任一成分过敏，或既往有任何疫苗接种严重过敏史，如荨麻疹、呼吸困难、血管神经性水肿； 5. 接种前3个月内，接受免疫抑制剂治疗（如长期应用全身糖皮质激素≥14天，剂量≥2mg/kg/天或≥20mg/天泼尼松或相当于泼尼松剂量）者（不包括吸入性、关节内和局部类固醇用药）；接种前3个月内或计划在试验期间使用全血或血液制品； 6. 接种前14天内接受过任何疫苗或28天内接受过减毒活疫苗接种； 7. 接种前3天内，患急性疾病或处于慢性病的急性发作期者； 8. 有惊厥、癫痫、脑病（如先天性脑发育不全、脑外伤、脑肿瘤、脑出血、脑梗死、脑部感染、化学药物中毒等引起的大脑神经组织损伤等）和精神病等病史或精神病家族史者； 9. 无脾或功能性无脾，以及任何情况导致的无脾或脾切除者； 10. 原发或继发免疫功能受损或已被诊断为患有先天性或获得性免疫缺陷、人类免疫性缺陷病毒（Human Immunodeficiency Virus ，HIV）感染、淋巴瘤、白血病、系统性红斑狼疮(SLE)、类风湿性关节炎、幼年型类风湿性关节炎（JRA）、炎症性肠病或其他自身免疫疾病者； 11. 患严重心血管疾病（肺心病、肺水肿），严重肝、肾疾病，有并发症的糖尿病者； 12. 有血小板减少或其它凝血障碍病史，可能造成肌肉注射禁忌者； 13. 药物无法控制的高血压患者（接种前体检收缩压≥160mmHg和/或舒张压≥100mmHg）； 14. 入组前3天内曾发热（腋温≥37.3℃），前7天内曾有需全身应用抗生素或抗病毒治疗的急性疾病或处于慢性感染急性期； 15. 接种前，实验室检查和心电图检查异常且经临床医生判定有临床意义者； 16. 处于哺乳期、孕期或从签署知情同意书开始至末次试验用疫苗接种后至少3个月内计划怀孕的女性，或从试验开始至末次试验用疫苗接种后至少3个月内计划其伴侣受孕的男性； 17. 长期酗酒或药物滥用史； 18. 首剂试验用疫苗接种前30天内或计划在本试验期间，参加其他药物或疫苗临床试验； 19. 研究者认为试验参与者存在其他不适合参加本试验的情况，包括但不限于不能按试验方案参加随访等。

Exclusion criteria：

1. History of suspected or confirmed herpes zoster; 2. History of varicella or herpes zoster vaccination; 3. History of varicella/herpes zoster exposure within 1 year prior to enrollment; 4. Allergy to any component of the trial vaccine or history of severe allergic reactions to any vaccine, such as urticaria, dyspnea, or angioedema; 5. Received immunosuppressive therapy (e.g., long-term systemic glucocorticoids >=14 days, dose >=2 mg/kg/day or >=20 mg/day prednisone or equivalent) within 3 months prior to vaccination (excluding inhaled, intra-articular, and topical corticosteroids); received whole blood or blood products within 3 months prior to vaccination or planned for use during the trial; 6. Received any vaccine within 14 days prior to vaccination or received a live attenuated vaccine within 28 days prior to vaccination; 7. Suffered from an acute illness within 3 days prior to vaccination or was in the acute phase of a chronic disease; 8. Has a history of seizures, epilepsy, encephalopathy (e.g., congenital brain dysplasia, brain trauma, brain tumors, cerebral hemorrhage, cerebral infarction, brain infections, or neurological tissue damage caused by chemical drug poisoning) or psychiatric disorders, or a family history of psychiatric disorders; 9. Is a splenectomy or functional splenectomy, or has undergone splenectomy for any reason; 10. Has primary or secondary immunodeficiency or has been diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune diseases; 11. Suffers from severe cardiovascular disease (pulmonary heart disease, pulmonary edema), severe liver or kidney disease, or diabetes with complications; 12. Has a history of thrombocytopenia or other coagulation disorders that may contraindicate intramuscular injection; 13. Has uncontrolled hypertension (pre-vaccination physical examination showing systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg); 14. Had a fever (axillary temperature >=37.3°C) within 3 days prior to enrollment, or had an acute illness requiring systemic antibiotic or antiviral therapy or was in the acute phase of a chronic infection within 7 days prior; 15. Had abnormal laboratory tests or electrocardiogram (ECG) findings prior to vaccination that were clinically significant as determined by a clinician; 16. Were lactating, pregnant, or planned to conceive within at least 3 months from the date of signing the informed consent form until the last trial vaccine administration, or were male participants planning to conceive their partner within at least 3 months from the start of the trial until the last trial vaccine administration; 17. Had a history of chronic alcohol abuse or substance abuse; 18. Had participated in other drug or vaccine clinical trials within 30 days prior to the first trial vaccine administration or planned to participate in such trials during the study; 19. The investigator determined that the participant had other conditions unsuitable for participation in the trial, including but not limited to inability to attend follow-up visits as per the trial protocol.

研究实施时间：

Study execute time：

从 From 2026-03-04 00:00:00至 To 2027-08-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-03-04 00:00:00 至 To 2027-08-01 00:00:00

干预措施：

Interventions：

组别：

重组带状疱疹疫苗（CHO细胞）（低剂量佐剂）组

样本量：

 36

Group：

Recombinant varicella-zoster vaccine (CHO cells) (low-dose adjuvant) Group

Sample size：

干预措施：

重组水痘-带状疱疹病毒糖蛋白E（gE）50 μg+低剂量佐剂系统

干预措施代码：

Intervention：

ecombinant varicella-zoster virus glycoprotein E (gE) 50 μg + low-dose adjuvant system

Intervention code：

组别：

重组带状疱疹疫苗（CHO细胞）（高剂量佐剂）组

样本量：

 36

Group：

Recombinant varicella-zoster vaccine (CHO cells) (high-dose adjuvant) Group

Sample size：

干预措施：

重组水痘-带状疱疹病毒糖蛋白E（gE）50 μg+高剂量佐剂系统

干预措施代码：

Intervention：

Recombinant varicella-zoster virus glycoprotein E (gE) 50 μg + high-dose adjuvant system

Intervention code：

组别：

重组带状疱疹疫苗（CHO细胞）的复合佐剂系统（低剂量）组

样本量：

 12

Group：

Recombinant Herpes Zoster Vaccine (CHO Cell) with Composite Adjuvant System (Low Dose) Group

Sample size：

干预措施：

低剂量佐剂系统

干预措施代码：

Intervention：

Low-dose adjuvant system

Intervention code：

组别：

重组带状疱疹疫苗（CHO细胞）的复合佐剂系统（高剂量）组

样本量：

 12

Group：

Recombinant Herpes Zoster Vaccine (CHO Cell) with Composite Adjuvant System (High Dose) Group

Sample size：

干预措施：

高剂量佐剂系统

干预措施代码：

Intervention：

High-dose adjuvant system

Intervention code：

组别：

安慰剂组

样本量：

 24

Group：

Placebo Group

Sample size：

干预措施：

氯化钠注射液

干预措施代码：

Intervention：

Sodium chloride injection

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

  

Country：

China

Province：

Hubei

City：

单位(医院)：

 湖北省疾病预防控制中心 

单位级别：

 无 

Institution
hospital：

Hubei Provincial Center for Disease Control and Prevention

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

疫苗每剂接种后30分钟、0~14天、0~30天不良事件发生率

指标类型：

主要指标

Outcome：

Adverse event rates at 30 minutes after each dose, 0-14 days, and 0-30 days post-vaccination.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疫苗首剂接种起至第2剂接种后12个月内SAE、AESI发生率

指标类型：

主要指标

Outcome：

Incidence of SAEs and AESIs from the first dose of vaccination to 12 months after the second dose

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疫苗每剂接种后第4天较每剂接种前，血常规、血生化、凝血功能及尿常规指标和心电图异常有临床意义的发生率

指标类型：

主要指标

Outcome：

The incidence of clinically significant abnormalities in complete blood count (CBC), blood biochemistry, coagulation function, urinalysis, and electrocardiogram (ECG) on day 4 after each vaccine dose compared to the pre-dose period.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疫苗每剂接种前、每剂接种后第30天、第2剂接种后6个月、第2剂接种后12个月，抗VZV抗原血清抗体阳转率、几何平均滴度（GMT）及几何平均增长倍数（GMI）

指标类型：

次要指标

Outcome：

Serum antibody seroconversion rate, geometric mean titer (GMT), and geometric mean increase (GMI) of anti-VZV antigen before each dose, on day 30 after each dose, 6 months after the second dose, and 12 months after the second dose

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疫苗每剂接种前、每剂接种后第30天、第2剂接种后6个月、第2剂接种后12个月，抗gE抗原血清抗体阳转率、GMC及GMI

指标类型：

次要指标

Outcome：

Serum antibody seroconversion rate, GMC, and GMI against gE antigen before each dose of vaccination, on day 30 after each dose, 6 months after the second dose, and 12 months after the second dose

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疫苗每剂接种前、每剂接种后第30天、第2剂接种后6个月、第2剂接种后12个月，分泌至少两种gE抗原特异性细胞因子（IFN-γ、IL-2、TNF-α、CD40L）的CD4+T细胞比例、细胞免疫应答率

指标类型：

次要指标

Outcome：

Vaccine: The proportion of CD4+ T cells secreting at least two gE antigen-specific cytokines (IFN-γ, IL-2, TNF-α, CD40L) and the cellular immune response rate before each dose, on day 30 after each dose, 6 months after the second dose, and 12 months after the second dose.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

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

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 40 岁 years
最大 Max age 岁 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）：

随机化统计师使用SAS9.4或以上版本的软件生成试验参与者随机表。试验参与者随机设计：各年龄、剂量、哨兵/非哨兵队列均采用区组随机化方法，按3:1:1的比例随机分配接种试验疫苗、佐剂和安慰剂。

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

The randomized statistician generated the trial participant randomization table using SAS 9.4 or later version software. Trial participant randomization design: All age groups, dose groups, and sentinel/non-sentinel cohorts were randomized using block randomization, with participants assigned to receive the trial vaccine, adjuvant, or placebo in a 3:1:1 ratio.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

本试验采用双盲设计，由随机化统计师与其他编盲人员进行疫苗编盲，即按照盲底将打印好的疫苗标签粘贴于每份疫苗指定位置。由随机化统计师督导疫苗编盲，指导编盲操作人员按照盲底进行贴签。完成编盲后，盲底由随机化统计师封存。盲底共两份，分别保存于申办者和试验机构。整个编盲过程须有文字记录。编盲人员不得参加本临床试验的其他相关工作，同时也不得向参加本临床试验工作的任何人员泄露盲底。 备用疫苗的编盲操作与试验疫苗的编盲操作相同。 试验期间若经主要研究者、申办者共同决定需要紧急揭盲时，由现场负责人由试验现场授权研究者登录临床试验中央随机化系统的紧急揭盲功能模块，按提示操作进行紧急揭盲，并进行相关记录。

Blinding：

This trial adopted a double-blind design, with vaccine blinding performed by a randomized statistician and other blinding personnel. Specifically, printed vaccine labels were affixed to designated positions on each vaccine according to the blinding base. The randomized statistician supervised the blinding process, instructing the blinding personnel to adhere to the blinding base. After blinding was completed, the blinding base was sealed by the randomized statistician. Two blinding bases were prepared and stored separately with the sponsor and the trial site. The entire blinding process required written documentation. Blinding personnel were prohibited from participating in any other related tasks of the clinical trial and were also forbidden from disclosing the blinding base to any individuals involved in the trial. The blinding procedures for the reserve vaccine were identical to those for the trial vaccine. During the trial, if the primary investigator and the sponsor jointly decide to perform emergency unblinding, the on-site principal investigator shall authorize the investigator at the trial site to log into the emergency unblinding module of the central randomized clinical trial system, follow the instructions to perform the emergency unblinding, and document the relevant records.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

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）：

药物临床试验登记与信息公示平台

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

https://www.chinadrugtrials.org.cn/index.html

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：

病例记录表及电子采集和管理系统

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

Case Record Form, CRF and Electronic Data Capture, EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-03-04 08:43:08