Impact of Immunosuppression Adjustment on the Immune Response to SARS-CoV-2 mRNA Vaccination in Kidney Transplant Recipients (ADIVKT)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in anti-SARS-CoV-2 IgG titer to SARS-CoV-2 target proteins from baseline
研究概览
简要总结
Immunocompromised individuals, such as solid organ transplant (SOT) recipients are at high risk of COVID-19 associated complications and mortality. Retrospective studies so far have shown that a majority of SOT recipients did not develop appreciable anti-spike antibody response after a first, second, or even third dose of mRNA vaccine. Treatment with antimetabolites was associated with poor vaccine response. The goal of this study is 1) examine whether transient immunosuppression reduction improves the immune response to a third dose of SARS-CoV-2 mRNA vaccine in kidney transplant recipients and 2) to assess the safety of immunosuppression reduction before and after third dose SARS-CoV-2 mRNA vaccination.
详细描述
This is a prospective, randomized open-labeled study of kidney transplant recipients who have previously received two doses of mRNA COVID-19 vaccine (either BNT162b2, Pfizer-BioNTech or mRNA-1273, Moderna) and who are eligible to receive a 3rd dose of mRNA vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Participant is willing and able to give informed consent for participation in the study
- •First or repeat kidney transplant recipient
- •Negative or low positive antibody titer on SARS-CoV-2 antibody assay
- •On a mycophenolate or azathioprine based immunosuppressive regimen
- •> 6 months post-transplant
排除标准
- •Pregnancy
- •Contraindication to SARS-CoV-2 vaccination (severe allergic reactions or anaphylaxis)
研究组 & 干预措施
Standard of care
No change to immunosuppression before or after receipt of a third dose of SARS-Co-2 mRNA vaccine
Immunosuppression reduction
Reduction of immunosuppression before and after administration of a third dose of SARS-CoV-2 mRNA vaccine
干预措施: Reduction in antimetabolite immunosuppression (Drug)
结局指标
主要结局
Change in anti-SARS-CoV-2 IgG titer to SARS-CoV-2 target proteins from baseline
时间窗: 6 weeks after receipt of 3rd dose mRNA vaccine
Percentage of participants who achieve high-positive antibody titer
时间窗: 6 weeks after receipt of 3rd dose mRNA vaccine
次要结局
- De Novo donor specific antibody (DSA) development(4 week to 16 weeks after intervention)
- Acute rejection(1 week to 16 weeks after intervention)
- Change in proteinuria from baseline(1 week to 16 weeks after intervention)
- Change in glomerular filtration rate (GFR) from baseline(1 week to 16 weeks after intervention)
- Change in donor-derived cell free DNA from baseline(1 week to 16 weeks after intervention)