Assessment of Association Between 3rd Dose of mRNA Vaccine and Risk of SARS-CoV-2 Infection in Kidney Transplant Recipients, Safety and Immunogenicity Assessment.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Immunological safety - anti-HLA antibodies
研究概览
简要总结
Prospective observational trial to assess immunological safety (anti-HLA antibodies, donor-derived cell-free DNA) and immunological effectiveness (anti-SARS-CoV-2 IgG) of the first booster dose of SARS-CoV-2 mRNA vaccines in kidney transplant recipients at least one year from transplantation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant recipients followed at Institute for Clinical and Experimental Medicine (IKEM)
- •vaccinated with 2 doses of mRNA vaccine (BNT-162b2 or mRNA-1273)
- •immunosuppressive regimen includes or does not include mycophenolic acid or mycophenolate mofetil
- •COVID naive
排除标准
- •age < 18 years
- •pregnant women, breastfeeding women
- •unable/unwilling to give informed consent
结局指标
主要结局
Immunological safety - anti-HLA antibodies
时间窗: Comparison of anti-HLA single antigen bead assays at booster dose and three months later.
Emergence of de novo anti-HLA/donor specific antibodies, increase of preformed anti-HLA/donor specific antibodies above 50% of pre-booster level.
Immunological safety - donor-derived cell-free DNA
时间窗: Comparison of dd-cfDNA assays at booster dose and three months later.
Elevation of dd-cfDNA above 1% threshold
次要结局
- Immunological effectiveness - anti-SARS-CoV-2 antibodies(Comparison of anti-SARS-CoV-2 IgG assays at booster dose and three months later.)
研究者
Prof. Ondřej Viklický, M.D., Ph.D.
Head of the Transplant Center, Head of the Department of Nephrology, Principle Investigator, Clinical Professor
Institute for Clinical and Experimental Medicine