ChiCTR2300067258 版本V1.2 版本创建时间2023/05/11 12:52:51 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：

 ChiCTR2300067258 

最近更新日期：

Date of Last Refreshed on：

 2023-01-02 00:09:45 

注册时间：

Date of Registration：

 2023-01-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

新冠疫苗接種對兒童眼表微生物群、角膜、葡萄膜、黃斑血管和視力的影響

Public title：

Impacts of COVID-19 vaccination on the ocular surface microbiota, cornea, uvea, macular vasculature and vision in children

注册题目简写：

English Acronym：

研究课题的正式科学名称：

新冠疫苗接種對兒童眼表微生物群、角膜、葡萄膜、黃斑血管和視力的影響

Scientific title：

Impacts of COVID-19 vaccination on the ocular surface microbiota, cornea, uvea, macular vasculature and vision in children

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：

Ms Jennifer Tsoi 

研究负责人：

梁婉兒博士 

Applicant：

Ms Jennifer Tsoi 

Study leader：

Dr BUI Huyen Trang 

申请注册联系人电话：

Applicant telephone：

 +852 39435818

研究负责人电话：

Study leader's
telephone：

+852 39435857

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：

 jennifertsoi@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 huyentrangbui@cuhk.edu.hk

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：

香港九龍亞皆老街147K號香港眼科醫院3樓

研究负责人通讯地址：

香港九龍亞皆老街147K號香港眼科醫院4樓

Applicant address：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

Study leader's address：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

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：

香港中文大學眼科及視覺科學學系

Applicant's institution：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學眼科及視覺科學學系

Affiliation of the Leader：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

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：

 2022.212

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-05-26 00:00:00

伦理委员会联系人：

Ms Envy Lee

Contact Name of the ethic committee：

Ms Envy Lee

伦理委员会联系地址：

香港新界沙田銀城街30-32號威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

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：

香港中文大學眼科及視覺科學學系

Primary sponsor：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

香港九龍亞皆老街147K號香港眼科醫院4樓

Primary sponsor's address：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

香港

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

香港中文大學眼科及視覺科學學系

具体地址：

香港九龍亞皆老街147K號香港眼科醫院4樓

Institution
hospital：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

Address：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

经费或物资来源：

香港中文大學眼科及視覺科學學系

Source(s) of funding：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

研究疾病：

COVID-19  

Target disease：

COVID-19

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

析因分组（即根据危险因素或暴露因素分组） 

Study design：

Factorial 

研究目的：

在這項研究中，我們計劃研究新冠疫苗: CoronaVac (Sinovac)「克爾來福」和 Comirnaty (BioNTech) 「復必泰」、對兒童眼部黏膜免疫反應。這些包括 2019冠狀病毒抗體和促炎細胞因子/趨化因子的誘導。我們亦會評估對眼部的影響、包括角膜、葡萄膜和黃斑血管系統的問題，以及對視力的影響。同時，我們將檢查眼表微生物群組成。  

Objectives of Study：

1. To analyse and compare the SARS-CoV-2-specific IgA, IgG and NAb responses and pro-inflammatory cytokine/chemokine induction in tears of Hong Kong children following Sinovac-CoronaVac and Pfizer-BioNTech vaccination. 2. To investigate and compare the ocular surface microbiota composition in Hong Kong children before and after Sinovac-CoronaVac and Pfizer-BioNTech vaccination. 3. To assess and compare the presentations of ocular manifestations, including those of the cornea, uvea and macular vasculature, in Hong Kong children following Sinovac-CoronaVac and Pfizer-BioNTech vaccination. 4. To examine and compare the effects of these vaccines on childrens vision.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Children from 5 to 11 years of age in Hong Kong with no prior history of SARS-CoV-2 infection or COVID-19 vaccination will be recruited into this study. They should be apparently healthy with no ocular or systemic disease and have no use of immunosuppressant, anti-inflammatory or antibiotic drugs or contact lenses in the past 6 months and no history of eye trauma or surgery. To screen for dry eye and other ocular abnormalities, they will be asked to respond to the Ocular Surface Disease Index Questionnaire (OSDI) and undergo a complete ophthalmological examination for both eyes: evaluation of VA using a logMAR
chart; refractive statuses by an auto-refractor; AL by IOL Master; anterior segment and retina examination and ACC count by a slit-lamp; lesions/abnormalities in the corneal epithelium, cornea, iris and anterior chamber and anterior chamber inflammatory cell quantification by AS-OCT; investigation of the deep layers of choroid and choroid imaging by OCT; OCT-A imaging on the fovea; and retinal photographs at the optic disc and fovea by a digital fundus camera, at the baseline visit (T0). Only those with an OSDI score below 13 and normal findings in the ophthalmological examination will continue in the study.

Inclusion criteria

Children from 5 to 11 years of age in Hong Kong with no prior history of SARS-CoV-2 infection or COVID-19 vaccination will be recruited into this study. They should be apparently healthy with no ocular or systemic disease and have no use of immunosuppressant, anti-inflammatory or antibiotic drugs or contact lenses in the past 6 months and no history of eye trauma or surgery. To screen for dry eye and other ocular abnormalities, they will be asked to respond to the Ocular Surface Disease Index Questionnaire (OSDI) and undergo a complete ophthalmological examination for both eyes: evaluation of VA using a logMAR
chart; refractive statuses by an auto-refractor; AL by IOL Master; anterior segment and retina examination and ACC count by a slit-lamp; lesions/abnormalities in the corneal epithelium, cornea, iris and anterior chamber and anterior chamber inflammatory cell quantification by AS-OCT; investigation of the deep layers of choroid and choroid imaging by OCT; OCT-A imaging on the fovea; and retinal photographs at the optic disc and fovea by a digital fundus camera, at the baseline visit (T0). Only those with an OSDI score below 13 and normal findings in the ophthalmological examination will continue in the study.

排除标准：

Participants who wear contact lenses, undergo eye surgery, or are diagnosed with an infection or receive vaccines other than those specified in the study at the recommended time by the HKSAR government (28 and 84 days apart, with a possible delay of 1 to 2 days, between the first and second doses for Sinovac-CoronaVac and Pfizer-BioNTech vaccines, respectively) during the study period will be excluded from the data analysis. To ensure the participants are negative for SARS-CoV-2 and influenza A/B viruses, detection for the viral RNA in the participants’ self-collected combined nasal and throat swab sample will be carried out using real-time PCR 1 to 2 days before each scheduled visit. Forehead temperatures will also be taken at the scheduled visit with an infrared thermometer to detect for fever, which is classified by a temperature of 38 degrees Celsius or above.

Exclusion criteria：

Participants who wear contact lenses, undergo eye surgery, or are diagnosed with an infection or receive vaccines other than those specified in the study at the recommended time by the HKSAR government (28 and 84 days apart, with a possible delay of 1 to 2 days, between the first and second doses for Sinovac-CoronaVac and Pfizer-BioNTech vaccines, respectively) during the study period will be excluded from the data analysis. To ensure the participants are negative for SARS-CoV-2 and influenza A/B viruses, detection for the viral RNA in the participants self-collected combined nasal and throat swab sample will be carried out using real-time PCR 1 to 2 days before each scheduled visit. Forehead temperatures will also be taken at the scheduled visit with an infrared thermometer to detect for fever, which is classified by a temperature of 38 degrees Celsius or above.

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2026-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-01-01 00:00:00 至 To 2026-05-31 00:00:00

干预措施：

Interventions：

组别：

將會接種「克爾來福」的參與者

样本量：

 150

Group：

CoronaVac (Sinovac) vaccine recipients

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

將會接種「復必泰」的參與者

样本量：

 150

Group：

Comirnaty (BioNTech) vaccine recipients

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

不會接種新冠疫苗的參與者

样本量：

 150

Group：

Unvaccinated controls

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 香港中文大學眼科中心 

单位级别：

  

Institution
hospital：

CUHK Eye Centre

Level of the institution：

测量指标：

Outcomes：

指标中文名：

IgA/IgG/NAb titres and pro-inflammatory cytokine/chemokine levels in tears and sera, 16S rRNA microbiome profiles in conjunctival swabs, and ocular manifestations/measurements from ophthalmological examination and questionaries pre- and post-vaccination.

指标类型：

主要指标

Outcome：

IgA/IgG/NAb titres and pro-inflammatory cytokine/chemokine levels in tears and sera, 16S rRNA microbiome profiles in conjunctival swabs, and ocular manifestations/measurements from ophthalmological examination and questionaries pre- and post-vaccination

Type：

Primary indicator

测量时间点：

6個月內4次隨訪

测量方法：

眼科檢查、樣本收集、問卷

Measure time point of outcome：

4 visits in 6-month follow-up

Measure method：

Eye examination, sample collection, questionnaires

指标中文名：

Similarities and/or differences between the data within/between different cohorts (Sinovac- CoronaVac and Pfizer-BioNTech vaccine recipients and unvaccinated controls) across/at different time points.

指标类型：

主要指标

Outcome：

Similarities and/or differences between the data within/between different cohorts (Sinovac- CoronaVac and Pfizer-BioNTech vaccine recipients and unvaccinated controls) across/at different time points.

Type：

Primary indicator

测量时间点：

6個月內4次隨訪

测量方法：

眼科檢查、樣本收集、問卷

Measure time point of outcome：

4 visits in 6-month follow-up

Measure method：

Eye examination, sample collection, questionnaires

指标中文名：

Potential correlation and casual relation

指标类型：

主要指标

Outcome：

Potential correlation and casual relation

Type：

Primary indicator

测量时间点：

6個月內4次隨訪

测量方法：

眼科檢查、樣本收集、問卷

Measure time point of outcome：

4 visits in 6-month follow-up

Measure method：

Eye examination, sample collection, questionnaires

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

淚液

组织：

Sample Name：

Tears

Tissue：

人体标本去向

 使用后保存  

说明

保存10年

Fate of sample：

Preservation after use  

Note：

10 years

标本中文名：

結膜拭子

组织：

Sample Name：

Conjunctival swabs

Tissue：

人体标本去向

 使用后保存  

说明

保存10年

Fate of sample：

Preservation after use  

Note：

10 years

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

保存10年

Fate of sample：

Preservation after use  

Note：

10 years

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 5 岁 years
最大 Max age 11 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）：

N/A

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

N/A

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：

Blinding：

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）：

N/A

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

N/A

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：

Patient data will be handled with utmost care so as not to breach patient privacy in any form. The data will be stored in secure cabinets and/or computers which will be password operated. To protect patient privacy, all research data will be handled in line with HA / Hospital’s policy in handling / storage / destruction of patients’ medical records. Electronic data will be saved in secured computers with restricted access. USB Device will not be used for patient information nor personal data. Personal data (name, HKID, OPD / hospital numbers, address and any other personal identifiable information) will not be recorded on the project’s data sheets or electronic files. A non-recognizable study code will be used for each patient instead. The document of electronic file containing the linkage information between the study code and the identity of the patient will not contain any other information and will be kept separate from the study data files or data sheets with the same stringent security as the medical record. Any documents or electronic files containing personal identifiable information will be considered as part of the medical record and will be dealt with the same stringent regulations of security according to the hospital policies. All of the investigators will be responsible for data handling and protection.

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

Patient data will be handled with utmost care so as not to breach patient privacy in any form. The data will be stored in secure cabinets and/or computers which will be password operated. To protect patient privacy, all research data will be handled in line with HA / Hospital’s policy in handling / storage / destruction of patients’ medical records. Electronic data will be saved in secured computers with restricted access. USB Device will not be used for patient information nor personal data. Personal data (name, HKID, OPD / hospital numbers, address and any other personal identifiable information) will not be recorded on the project’s data sheets or electronic files. A non-recognizable study code will be used for each patient instead. The document of electronic file containing the linkage information between the study code and the identity of the patient will not contain any other information and will be kept separate from the study data files or data sheets with the same stringent security as the medical record. Any documents or electronic files containing personal identifiable information will be considered as part of the medical record and will be dealt with the same stringent regulations of security according to the hospital policies. All of the investigators will be responsible for data handling and protection.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-01-01 22:03:17