The Fifth Medical Center of Chinese PLA General Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Safety of coronavirus vaccine
研究概览
简要总结
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with cancers may be at higher risk than those without cancer for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of COVID-19 vaccination for patients with cancer.
详细描述
This study is a prospective, single-arm, open-label clinical trial. A total of 300 patients with different cancers including hepatocellular carcinoma, breast cancer, lung cancer, esophageal cancer, gastric cancer and colorectal cancer were included in this vaccination study. All of the patients will further accept 12 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 above 18 years
- •Patients with diagnosed cancers including hepatocellular carcinoma, breast cancer, lung cancer, esophageal cancer, gastric cancer and colorectal cancer were included .
- •Patients who have received local or systemic anti-cancer therapies according to the treatment guidelines previously or currently, and have a stable condition with the ECOG score below
- •The functions of multi-organs were normal or basically normal, and there are no contraindications for vaccination.
排除标准
- •Patients with acute attack of chronic diseases.
- •Patients have history of convulsion, epilepsy, encephalopathy and psychosis.
- •Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
- •Pregnant or lactating women.
- •Sufferring serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
- •Patients have severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired angioedema / neuroedema.
- •Systemic cytotoxic drugs, cell therapies including NK cells, cytokine induced killer cells, Dendritic cells, CTL and stem cells infusion are required during vaccination.
结局指标
主要结局
Safety of coronavirus vaccine
时间窗: Within 2 months after the first dose of coronavirus vaccine
Occurence of adverse effects after COVID-19 vaccination
Immunogenicity of coronavirus vaccine
时间窗: Within 2 months after the first dose of coronavirus vaccine
Titers of anti-SARS-CoV-2 antibodies
次要结局
- Safety of coronavirus vaccine(Within 13 months after the first dose of coronavirus vaccine)
- Immunogenicity of coronavirus vaccine(Within 13 months after the first dose of coronavirus vaccine)