NCT04969614Unknown不适用
Safety and Immunogenicity of 2-dose Inactivated COVID-19 Vaccine in Kidney Transplant Recipients: a Prospective Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- seropositive anti-COVID-19 antibody
研究概览
简要总结
The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has a major impact on transplant recipients, with mortality rates up to 20%. However, immunocompromised individuals have been excluded from studies of SARS-CoV-2 vaccines. In such patients, the immune response to vaccination may be blunted. To better understand the immunogenicity of SARS-CoV-2 vaccines in transplant recipients, we quantified the humoral response to SARS-CoV-2 vaccine in kidney transplant recipients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving kidney transplantation in West China Hospital, Sichuan University
排除标准
- •History of rejection or infection over the previous 3 months; 2) receiving kidney transplantation >3 months; 3) Combined with HBV/HVC/HIV infection in the donor or recipient; 4) Malignancy history in the donor and recipient; 5) organ transplant history in the recipient.
结局指标
主要结局
seropositive anti-COVID-19 antibody
时间窗: 2 to 6 weeks after the second injection of inactivated vaccine
seropositive anti-COVID-19 antibody, including IgM, IgG, and IgA
次要结局
未报告次要终点
研究者
Tao Lin
West China Hospital
West China Hospital
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