Correlation Study of Isotype Switching and Neutralizing Capacity to the COVID-19 Variants Strain
2021年10月19日 更新者:Wu Jiang、Centers for Disease Control and Prevention, China
Study on the Correlation of Isotype Switching, Neutralizing Antibody Titer and Cross Immunity Against COVID-19 Variants After Primary and Booster Vaccination
The level of neutralizing antibody was detected by using the constructed pseudovirus covid-19 variant at baseline , 1 month , 6 months and 12 months after primary vaccination, within 15 days after booster immunization at 12 months .
and the ability of IgG subclasses to neutralize and cross immunization of variant strains was analyzed.
研究概览
地位
主动,不招人
条件
详细说明
In 150 individuals who received primary and booster COVID-19 inactivated vaccine, the neutralization ability of antibodies against covid-19 mutant after primary and booster immunization was evaluated by constructing pseudotyped SARS-CoV-2 variants.
The contribution and influence of IgG subclasses on neutralization capacity were assessed by Elisa assay.
All participants were recruited aged between 18 and 59 years old.
Every participant was familiarized with the aim of the study and asked to sign an informed consent agreement and was required blood sampling at the day 0 of first dose vaccine and 1 month, 6 months after 2nd dose of primary immunization.
All participants had received 1 dose of booster immunization at 12 months after fully primary vaccination.
Then 150 people were divided into four groups, Blood samples were taken on days 0,3,7,10 and 14 to detect neutralizing antibodies and IgG subclasses separately.
every sample was detected SARS-CoV-2 variants strain Alpha, Beta and Delta neutralizing antibody, and RBD-IgG1, IgG2, IgG3, and IgG4.
every individual was conducted a detailed analysis correlation of isotype switching, neutralizing antibody titer and cross immunity against COVID-19 variants after primary and booster vaccination.
研究类型
观察性的
注册 (实际的)
150
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Beijing、中国、100013
- Center for Disease Control and Prevention
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 59年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
概率样本
研究人群
The healthy people aged between 18 and 59, and have not been infected with COVID-19, have not been vaccinated with COVID-19 vaccine, and agree to collect blood samples.
描述
Inclusion Criteria:
- Between the ages of 18 and 59
- Healthy
- No vaccination with COVID-19 before become participant
- Agreed to take a blood sample
Exclusion Criteria:
- who cannot take the COVID-19 vaccine due to some personal reasons
- history of SARS-CoV, SARS-CoV-2, or Middle East respiratory syndrome infection
- high-risk epidemiology history within 14 days before enrolment (eg, travel or residence history in communities with case reports, or contact history with someone infected with SARS-CoV-2)
- axillary temperature of more than 37·0℃
- history of allergy to any vaccine component.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Neutralizing capabilities to variant COVID-19 after primary and booster vaccination
大体时间:Baseline,After fully vaccinated 1 and 6 months,Within 15 days after booster immunization at 12 months
|
The titers of neutralizing antibodies against live SARS-CoV-2 and Pseudotyped SARS-CoV-2 Variants strain Alpha, Beta and Delta at baseline, after fully vaccinated 1 and 6 months and Within 15 days after booster immunization at 12 months. The neutralizing antibodies was defined as a change from seronegative at baseline to seropositive or a four-fold titer increase. The positive cutoff of the titer for neutralizing antibodies was 1/30. |
Baseline,After fully vaccinated 1 and 6 months,Within 15 days after booster immunization at 12 months
|
|
Titer of Subclass of IgG after primary and booster vaccination
大体时间:Baseline,After fully vaccinated 1 and 6 months,Within 15 days after booster immunization at an interval of 12 months
|
The titers of Subclass RBD-specific IgG1, IgG2,IgG3 and IgG4 at baseline, after fully vaccinated 1 and 6 months and Within 15 days after booster immunization at an interval of 12 months.
The positive for IgG1, IgG2,IgG3 and IgG4 antibodies are defined as the sample titer value ≥1/20.
|
Baseline,After fully vaccinated 1 and 6 months,Within 15 days after booster immunization at an interval of 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Titer of subclass of IgG at different points in time after booster vaccination
大体时间:0,3,7,10,14 days
|
Titer of subclass of IgG at 0,3,7,10,14 days after booster vaccination.
The positive for IgG1, IgG2,IgG3 and IgG4 antibodies are defined as the sample titer value ≥1/20.
|
0,3,7,10,14 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年7月20日
初级完成 (实际的)
2021年10月10日
研究完成 (预期的)
2021年10月30日
研究注册日期
首次提交
2021年10月19日
首先提交符合 QC 标准的
2021年10月19日
首次发布 (实际的)
2021年10月21日
研究记录更新
最后更新发布 (实际的)
2021年10月21日
上次提交的符合 QC 标准的更新
2021年10月19日
最后验证
2021年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.