NCT05047640终止3 期
A Single-Blind, Randomized, Controlled Trial Comparing BNT162b2 vs JNJ-78436735 Vaccine as a Booster Dose After Completion of BNT162b2 Vaccine in Solid Organ Transplant Recipients
Giselle Guerra2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2021年9月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Percentage of Participants Who Tested Positive for IgG Antibodies to the Anti-spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
研究概览
简要总结
The purpose of this study is to investigate the efficient vaccine type as a booster dose for Coronavirus Disease of 2019 (COVID-19) in solid organ transplant recipients.
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
- Single (Participant)
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
- •Patients 18 years of age and older
- •Patients who had received a solid organ (kidney, liver, lung, heart, and pancreas) transplant patient from living or deceased donors.
- •Patients with active graft with at least one immunosuppressive medication
- •Completed two doses of BNT162b2 vaccination at least 28 days ago
排除标准
- •Patient with non-active graft
- •Any significant side effect with previous COVID-19 vaccination
- •Within 28 days of BNT162b2 vaccine completion
- •Already received more than and equal to three doses of COVID-19 vaccination
- •Previously received COVID-19 vaccine other than BNT162b2 vaccine
- •Previously received monoclonal Antibody treatment that are specifically directed against the spike protein for Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (CoV)-2 such as Mab, Bamlanivimab, etesevimab, Casirivimab, imdevimab, Sotrovimab and/or any combination.
- •Thrombocytopenia (if less than 50,000 per microliter 30 days prior vaccination)
- •History of Capillary Leak Syndrome
- •Adults unable to consent
- •Individuals who are not yet adults (younger than 18 year old)
- •Vulnerable patients (prisoners)
- •Pregnant women
结局指标
主要结局
Percentage of Participants Who Tested Positive for IgG Antibodies to the Anti-spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
时间窗: Up to 1 month (post booster vaccination)
Anti-spike protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) virus Immunoglobulin G (IgG) positivity rate will be assessed from serum blood samples
次要结局
- Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale(Up to 1 month (post third dose))
- Number of Participants With Vaccine-related Adverse Events(Up to 7 days (post third dose))
- Proportion of Participants With a Positive COVID-19 Test(Up to 1 month (post third dose))
研究者
Giselle Guerra
Medical Director of Transplant Services
University of Miami
研究点 (2)
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