NCT04930770撤回2 期
Study About the Response to the Administration of a Third Dose of mRNA-1273 Vaccine (COVID-19 Vaccine Moderna) in Renal Transplants With Immunological Failure Initial to Vaccination
Maria Joyera Rodríguez0 个研究点开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Number of patients with development of cellular and humoral immunity against SARS-CoV-2
研究概览
简要总结
The objective will be to analyze the development of cellular and humoral immunity against SARS-CoV-2 after administration of a third dose of mRNA-1273 (Moderna) vaccine in patients who have remained seronegative after the full standard (two-dose) regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age > 18 years;
- •Male or female sex;
- •Renal transplant with stable renal function in the last 2 months prior to study inclusion.
- •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.
- •Patient giving written informed consent.
排除标准
- •Renal transplantation < 3 months;
- •Pregnancy or lactation status;
- •Rejection treated within the last 6 months;
- •Presence of humoral immunity to SARS-CoV-2 defined as the presence of specific IgM/IgG.
研究组 & 干预措施
Renal/renopancreatic transplant's patients with a verified seronegativity
Experimental
干预措施: MRNA-1273 (Drug)
结局指标
主要结局
Number of patients with development of cellular and humoral immunity against SARS-CoV-2
时间窗: 2 weeks
the development of cellular and humoral immunity against SARS-CoV-2 after administration of a third dose of mRNA-1273 (Moderna) vaccine in patients who have remained seronegative after the full standard (two-dose) regimen
次要结局
- Number of patients with development of cellular and humoral immunity against SARS-CoV-2(4 months)
- patient characteristics associated with biological non-response to vaccination(4 months)
- Incidence of Treatment-Emergent Adverse Events(4 months)
研究者
Maria Joyera Rodríguez
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica
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