ACTRN12622001106729已完成4 期
Safety and efficacy of the 3rd and the 4th dose of mRNA COVID19 vaccine in kidney transplant recipients
Martin Kacer0 个研究点目标入组 126 人开始时间: 2022年8月10日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Adult (>18 years with no upper age limit) renal transplant (deceased or living donor) recipients, male or female.
- •-SARS-CoV-2 naive prior standard 2-dose vaccination and before booster doses
- •-Completed standard vaccination schedule with BNT162b2, Pfizer/BioNTech
- •-SARS-CoV-2 specific IgG antibody titer < 10 arbitrary units per milliliter (AU/mL)
- •-Ability to sign informed consent.
排除标准
- •-Confirmed active (RT-PCR) SARS-CoV-2 infection throughout the study
- •-Known previous SARS-CoV-2 infection
- •-SARS-CoV-2 specific IgG antibody titer greatrer than 10 arbitrary units per milliliter (AU/mL) upon enrollment
- •-Inability to complete full booster vaccination schedule (allergy, infection, etc.).
- •-Signs of active infection in baseline
- •-Inability to sign informed consent.
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