EUCTR2021-002356-37-ES进行中(未招募)1 期
Study about the response to the administration of a third dose of mRNA-1273 vaccine (COVID19 vaccine Moderna) in renal transplants with immunological failure initial to vaccination
Fundació Clinic per a la Recerca Biomèdica (FCRB)0 个研究点目标入组 80 人开始时间: 2021年9月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age > 18 years;
- •2. Male or female sex;
- •3. Renal transplant with stable renal function in the last 2 months prior to study inclusion;
- •4.Had received a full schedule of vaccination for SARS-CoV-2 with mRNA1273 vaccine (Moderna) and remained seronegative at 2 weeks after the second dose.
- •5.Patient giving written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •1. Renal transplantation < 3 months;
- •2. Pregnancy or lactation status;
- •3. Rejection treated within the last 6 months;
- •4. Presence of humoral immunity to SARS-CoV-2 defined as the presence of specific IgM/IgG.
研究者
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