A Prospective Cohort Study on Antibody Persistence and Immune Memory After Two Doses of Inactivated COVID-19 Vaccine in 150 People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Durability of humoral and cellular immune responses
研究概览
简要总结
The study describe 1 year durability of humoral and cellular immune responses in 150 individuals who received COVID-19 inactivated vaccine. 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 be required blood sampling at the day 0 of first dose vaccine and 1 month, 3 months, 6 months and 12 months after fully vaccination separately. From every sample, 10 ml, 10 ml, and 5 ml were dispensed in three vacuum blood collection tubes. Peripheral blood lymphocytes cell (PBMC) were isolated with the two 10 ml samples contained heparin to detect immune memory cells and cytokines. RBD-IgG and neutralizing antibody be detected by 5ml sample from separating gel vacuum tubes. every individual conducted a detailed analysis comparing neutralizing antibody, TEM, TCM , and report on the cellular and humoral immunity 1 year after accept COVID-19 vaccine.
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
- •Working at the CDC
- •Between the ages of 18 and 59
- •Not vaccinated with COVID-19 vaccine
- •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
Durability of humoral and cellular immune responses
时间窗: 12 months after fully vaccination
The humoral immunogenicity outcomes include the RBD-specific IgG titers and neutralising antibodies amounts at 1, 3, 6, and 12 months after the second shot. The positive cutoff for RBD-specific IgG antibodies was defined as the sample cutoff (S/CO) value ≥1.0. Seroconversion of neutralising antibodies was defined as a change from seronegative at baseline to seropositive or a four-fold titre increase. The positive cutoff of the titre for neutralising antibodies was 1/4. The cellular immune response outcomes measured by ICS assays across the blood collection time points.the percentage of RBD-specific CD4+ CD8+ memory T cells after vaccination.
次要结局
- The dynamic variation of the level of antibody(1，3，6 , 12 month)
- Cytokine secretion by peripheral blood mononuclear cells(1,3,6,12 month)
- TCM and TEM amount varies at different time points(1,3,6,12 month)
研究者
Wu Jiang
Director of Institute for Vaccines and Immunization
Centers for Disease Control and Prevention, China