Study on the Correlation of Isotype Switching, Neutralizing Antibody Titer and Cross Immunity Against COVID-19 Variants After Primary and Booster Vaccination
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Neutralizing capabilities to variant COVID-19 after primary and booster vaccination
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18 and 59
- •No vaccination with COVID-19 before become participant
- •Agreed to take a blood sample
排除标准
- •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.
结局指标
主要结局
Neutralizing capabilities to variant COVID-19 after primary and booster vaccination
时间窗: 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.
Titer of Subclass of IgG after primary and booster vaccination
时间窗: 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.
次要结局
- Titer of subclass of IgG at different points in time after booster vaccination(0,3,7,10,14 days)
研究者
Wu Jiang
Director of Institute for Vaccines and Immunization
Centers for Disease Control and Prevention, China