NCT04910295已完成不适用
Immunogenicity and Safety of COVID-19 Vaccine in Cancer Patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Antibody titre after vaccination
研究概览
简要总结
Serum antibody titre against COVID-19 spike protein will be measured before, after the first dose, and after the second dose (when applicable) in cancer patients who are receiving or received anti-cancer drugs. Side effects of vaccination and actual incidence of COVID-19 will be monitored.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years of age or older
- •Patients who are receiving or received anti-cancer drugs
- •Those who are not vaccinated against COVID-19 at the time of enrollment
- •Written informed consent
排除标准
- •Any contraindications to COVID-19 vaccines
- •Those who were already vaccinated
- •Those who are on immunosuppressants or infected with HIV
- •Those who underwent organ transplantation
- •Active infections (for example, pneumonia)
结局指标
主要结局
Antibody titre after vaccination
时间窗: 21-28 days after completion of vaccination
Antibody titre as measured by Anti-SARS-CoV-2 ELISA (IgG)
次要结局
- Antibody titer according to chemotherapy cycle, side effects, and use of corticosteroids or antipyretics(21-28 days after completion of vaccination)
- Incidence of COVID-19 infection(6 months after completion of vaccination)
研究者
Kyung-Hun Lee
Professor
Seoul National University Hospital
研究点 (1)
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