Safety and Immunogenicity of COVID-19 Vaccines in Patients With Chronic Liver Disease: A Multi-center Prospective Study
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 chronic liver disease (CLD) are at higher risk of mortality and morbidity due to COVID-19. Despite there is a large number of clinical trials of COVID-19 vaccines, only a few participants with chronic liver diseases were included.
详细描述
This study is a prospective, open-label clinical trial. A total of 300 patients with different cancers including chronic hepatitis, cirrhosis .All of the patients will further accept 18 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 ≥ 18 years.
- •Serum ALT and AST are both ≤ 80 U/L.
- •HIV and TPHA screening were negative.
- •Body temperature ≤37.0℃.
排除标准
- •Patients who confirmed the diagnosis of liver cancer by imaging examination (CT/MRI/B scan).
- •Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
- •Women who is pregnant, breastfeeding, or planning to be pregnant within 6 months.
- •Patients with cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
- •Patients with 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.c.
- •Patients with urticaria within a year.
- •Patients with coagulation disorder.
- •Faintng during acupuncture treatment .
- •Patients who received other investigational drugs within one month.
- •Be receiving anti-TB treatment.
- •Other conditions determined by the researcher.
结局指标
主要结局
Safety of coronavirus vaccine
时间窗: Within 2 months after the first dose of COVID-19 vaccination
Rate of adverse effects after COVID-19 vaccination
Immunogenicity of coronavirus vaccine
时间窗: Within 2 months after the first dose of COVID-19 vaccination
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies
次要结局
- Immunogenicity of coronavirus vaccine(Within 18 months after the first dose of COVID-19 vaccination)
- Safety of coronavirus vaccine(Within 18 months after the first dose of COVID-19 vaccination)