ChiCTR2500112191 版本V1.0 版本创建时间2025/11/11 11:54:06 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：

 ChiCTR2500112191 

最近更新日期：

Date of Last Refreshed on：

 2025-11-11 11:53:59 

注册时间：

Date of Registration：

 2025-11-11 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

三价流感病毒裂解疫苗在18岁及以上HIV感染者中的免疫原性和安全性研究

Public title：

Study on the immunogenicity and safety of trivalent influenza virus split vaccine in HIV infected individuals aged 18 and above

注册题目简写：

English Acronym：

研究课题的正式科学名称：

三价流感病毒裂解疫苗在18岁及以上HIV感染者中的免疫原性和安全性研究

Scientific title：

Study on the immunogenicity and safety of trivalent influenza virus split vaccine in HIV infected individuals aged 18 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：

戚小华 

研究负责人：

戚小华 

Applicant：

Xiaohua Qi 

Study leader：

Xiaohua Qi 

申请注册联系人电话：

Applicant telephone：

 +86 571 8711 5141

研究负责人电话：

Study leader's
telephone：

+86 571 8711 5141

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：

 xhqi@cdc.zj.cn

研究负责人电子邮件：

Study leader's E-mail：

 xhqi@cdc.zj.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)：

申请注册联系人通讯地址：

浙江省杭州市滨江区滨盛路3399号

研究负责人通讯地址：

浙江省杭州市滨江区滨盛路3399号

Applicant address：

No. 3399, Binsheng Road, Binjiang District, Hangzhou City, Zhejiang Province

Study leader's address：

No. 3399, Binsheng Road, Binjiang District, Hangzhou City, Zhejiang 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：

浙江省疾病预防控制中心

Applicant's institution：

Zhejiang Provincial Center for Disease Control and Prevention

研究负责人所在单位：

浙江省疾病预防控制中心

Affiliation of the Leader：

Zhejiang 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：

 2024-052-01

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：

浙江省疾病预防控制中心伦理审查委员会

Name of the ethic committee：

Institutional Review Boards of Zhejiang Provincial Center for Disease Control and Prevention

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-11-01 00:00:00

伦理委员会联系人：

吴晓丽

Contact Name of the ethic committee：

Xiaoli Wu

伦理委员会联系地址：

浙江省杭州市滨江区滨盛路3399号

Contact Address of the ethic committee：

No. 3399, Binsheng Road, Binjiang District, Hangzhou City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 575 87115103

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 xlwu@cdc.zj.cn

研究实施负责（组长）单位：

浙江省疾病预防控制中心

Primary sponsor：

Zhejiang Provincial Center for Disease Control and Prevention

研究实施负责（组长）单位地址：

浙江省杭州市滨江区滨盛路3399号

Primary sponsor's address：

No. 3399, Binsheng Road, Binjiang District, Hangzhou City, Zhejiang 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)：

浙江省

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

浙江省疾病预防控制中心

具体地址：

浙江省杭州市滨江区滨盛路3399号

Institution
hospital：

Zhejiang Provincial Center for Disease Control and Prevention

Address：

No. 3399, Binsheng Road, Binjiang District, Hangzhou City, Zhejiang Province

经费或物资来源：

长春生物制品研究所有限责任公司

Source(s) of funding：

Changchun Institute of Biological Products

研究疾病：

获得性免疫缺陷综合征  

Target disease：

Acquired immune deficiency syndrome

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评价18岁及以上HIV感染者接种三价流感病毒裂解疫苗（IIV3）后的抗体水平和安全性数据，探索性评价HIV感染者接种IIV3对流感样病例（ILI）的保护效力，补充完善国内免疫缺陷人群接种IIV3的免疫原性、安全性和保护效力证据，为今后国内外流感防控策略提供参考依据。  

Objectives of Study：

Evaluate the antibody levels and safety data of HIV infected individuals aged 18 and above who have received trivalent influenza virus split vaccine (IIV3), explore the protective effect of IIV3 on influenza like cases (ILI) in HIV infected individuals, supplement and improve the evidence of immunogenicity, safety, and protective effect of IIV3 for immunocompromised populations in China, and provide reference for future influenza prevention and control strategies at home and abroad.

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. 18岁及以上HIV 感染者或非HIV感染者。 2. 受试者入组前1年内未曾接种过任何流感疫苗。 3. 受试者与最近1次减毒类疫苗间隔至少一个月；与灭活疫苗或其他疫苗接种间隔>=14天。 4. 对于育龄女性接种者，在筛选后的前3个月内无生育计划，在筛选前2周内已采取有效的避孕措施。 5. 在进入这项研究之前，经病史和临床检查，且体温＜37.3℃。 6. 受试者或其监护人有能力了解研究程序，经知情同意，自愿签署知情同意书，能够遵守临床研究方案的要求，能够且愿意完成整个规定研究计划。

Inclusion criteria

1. HIV infected / non-infected individuals aged 18 and above. 2. The subject has not received any influenza vaccine within the year prior to enrollment. 3. The subject should be at least one month away from the last dose of attenuated vaccine; The interval between vaccination with inactivated vaccines or other vaccines is >= 14 days. 4. For women of childbearing age who have received vaccination, if they have no plans to have children within the first 3 months after screening and have taken effective contraceptive measures within 2 weeks before screening. 5. Before entering this study, medical history and clinical examination were conducted, and the body temperature was less than 37.3 ℃. 6. The subjects or their guardians have the ability to understand the research procedures, voluntarily sign the informed consent form with informed consent, comply with the requirements of the clinical research protocol, and are able and willing to complete the entire prescribed research plan.

排除标准：

1. 已知对该疫苗所含任何成分，包括鸡蛋、辅料、甲醛、硫酸庆大霉素、Triton X-100过敏者。
2. 妊娠期、哺乳期妇女。
3. 既往有研究疫苗及其他流感疫苗接种过敏史者（如急性过敏反应、血管神经性水肿、呼吸困难等）。
4. 患惊厥、脑病、精神病、未控制的癫痫和其他进行性神经系统疾病等病史或家族史者，有格林巴利综合征病史者。
5. 入组前1个月内使用免疫抑制剂。
6. 入组前3个月内接受过血液制品或免疫球蛋白以及任何其他可能干扰研究结果的情况。
7. 有明确诊断的血小板减少或其它凝血障碍病史，可能造成肌内注射禁忌者。
8. 患急性疾病（如急性发热性疾病者及传染病者），慢性病急性发作期患者。
9. 研究者认为有可能影响研究评估的任何情况。

Exclusion criteria：

1. Known allergy to any component of the vaccine, including eggs, adjuvants, formaldehyde, gentamicin sulfate, and Triton X-100;
2. Pregnant or lactating women;
3. History of allergic reactions to the study vaccine or other influenza vaccines (e.g., acute allergic reactions, angioneurotic edema, difficulty breathing);
4. Personal or family history of convulsions, encephalopathy, psychiatric disorders, uncontrolled epilepsy, or other progressive neurological disorders, and history of Guillain-Barré Syndrome;
5. Use of immunosuppressants within one month prior to enrollment;
6. Receipt of blood products or immunoglobulin within three months prior to enrollment, or any other condition that may interfere with study results;
7. History of diagnosed thrombocytopenia or other coagulation disorders that may contraindicate intramuscular injection;
8. Suffering from acute illnesses (e.g., acute febrile diseases or infectious diseases) or in the acute exacerbation phase of chronic diseases;
9. Any condition that, in the investigator's opinion, may affect the assessment of the study.

研究实施时间：

Study execute time：

从 From 2024-12-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-12-03 00:00:00 至 To 2025-02-27 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 236

Group：

Experimental Group

Sample size：

干预措施：

接种三价流感病毒裂解疫苗

干预措施代码：

Intervention：

Administration of the Trivalent Influenza Virus Split Vaccine

Intervention code：

组别：

对照组1

样本量：

 236

Group：

Control Group 1

Sample size：

干预措施：

HIV感染者不接种IIV3（采用分层随机设计的方法随机分配入组，目标入组人数236人）。第0天，发放日记卡，并通过联系卡每7天现场/电话随访受试者，收集流感样病例（ILI）发生情况；第28天，回收日记卡。

干预措施代码：

Intervention：

Hiv-infected individuals were not vaccinated with IIV3 (randomly assigned and enrolled using a stratified randomized design method, with a target enrollment of 236 people). On day 0, diary cards were distributed, and the subjects were followed up on-site/by phone every 7 days through the contact cards to collect the occurrence of influenza-like illness (ILI) cases. On the 28th day, collect the diary cards.

Intervention code：

组别：

对照组2

样本量：

 236

Group：

Control Group 2

Sample size：

干预措施：

非HIV感染者接种IIV3。第0天，采集免前体液免疫血标本，接种1剂次IIV3（0.5ml），发放日记卡，并通过联系卡每7天现场/电话随访受试者，收集流感样病例（ILI）发生情况；第28天，采集免后体液免疫血标本，回收日记卡。

干预措施代码：

Intervention：

Non-hiv-infected individuals receive IIV3 vaccination. On day 0, blood samples for pre-immunization humoral immunity were collected. One dose of IIV3 (0.5ml) was administered, diary cards were distributed, and the subjects were followed up on-site or by phone every 7 days through contact cards to collect the occurrence of influenza-like illness (ILI). On the 28th day, blood samples for post-immunization humoral immunity were collected and diary cards were retrieved.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China

Province：

Zhejiang

City：

单位(医院)：

 浙江省疾病预防控制中心 

单位级别：

 无  

Institution
hospital：

Zhejiang Provincial Center for Disease Control and Prevention

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

免疫原性指标

指标类型：

主要指标

Outcome：

Immunogenicity markers

Type：

Primary indicator

测量时间点：

免后28（+5）天

测量方法：

采血化验，进行H1N1型、H3N2型、BV型血清HI抗体水平检测。

Measure time point of outcome：

28 (+5) days post-vaccination

Measure method：

Blood tests were conducted to measure serum hemagglutination inhibition (HI) antibody levels for H1N1, H3N2, and influenza B virus (BV) types.

指标中文名：

安全性指标

指标类型：

主要指标

Outcome：

Safety indicators

Type：

Primary indicator

测量时间点：

免后6个月

测量方法：

通过日记卡、联系卡进行主动监测和被动随访

Measure time point of outcome：

6 months post-vaccination

Measure method：

Conduct active monitoring and passive follow-up using diary cards and contact cards.

指标中文名：

保护效力指标

指标类型：

次要指标

Outcome：

Protection efficacy indicators

Type：

Secondary indicator

测量时间点：

疫苗接种后6个月内

测量方法：

关注疫苗接种后6个月内ILI发生情况，通过联系卡每7天现场/电话随访受试者收集ILI。 参照《全国流感监测技术指南》（2017版）中流感样病例（Influenza-like Illness，ILI）定义（体温≥38.0℃，伴咳嗽或咽痛之一者）进行收集。

Measure time point of outcome：

6 months post-vaccination

Measure method：

Monitor the occurrence of influenza-like illness (ILI) within 6 months post-vaccination by conducting on-site or telephone follow-ups every 7 days using contact cards to gather ILI data. Collection is based on the definition of ILI as outlined in the "National Influenza Surveillance Technical Guidelines" (2017 edition), which defines an ILI case as having a fever (body temperature ≥38.0°C) accompanied by either a cough or sore throat.

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 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）：

统计公司采用软件生成

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

Statistical companies use software to generate results

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

开放标签

Blinding：

Open-label study

是否共享原始数据：

IPD sharing

是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）：

研究结束后，通过ResMan(www.medresman.org.cn)方式共享

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

After the end of the study, it was shared by ResMan (www.medresman.org.cn).

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：

CRF;EDC

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

CRF;EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-11-11 11:53:59