Safety and Efficacy of Inactivated SARS-CoV-2 Vaccine in Immune-related Myopathy (Myasthenia Gravis and Inflammatory Myopathy) Patients ：a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 主要终点
- Serum specific antibody
研究概览
简要总结
This study is a prospective observational study. We aim to investigate the safety and efficacy of inactivated SARS-CoV-2 vaccine between immune-related myopathy (myasthenia gravis and inflammatory myopathy) patients and health controls. The main study factors include adverse events following immunization (AEFI), serum specific antibody (Acetylcholine receptor (AChR) antibody, Anti-MuSK (muscle-specific kinase) antibody, myositis antibody) and virus neutralizing antibody titers.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Complete behavioral ability
- •Voluntary willingness to vaccinate
- •Clinically confirmed immune-related myopathy (myasthenia gravis and inflammatory myopathy) and immune-related myopathy (myasthenia gravis and inflammatory myopathy)was stable
- •Informed consent to the research
排除标准
- •No independent behavior ability
- •Vaccination is contraindicated
- •Other diseases that significantly affect the immune function
- •Other diseases that may significantly affect immune function are being treated
- •Vaccination contraindication was found during the study observation period
- •Other diseases that may significantly affect immune function were diagnosed during the study observation period
- •Treatments for other diseases that may significantly affect immune function were initiated during the study observation period
- •Refused regular follow-up
结局指标
主要结局
Serum specific antibody
时间窗: 6 months
Serum specific antibody of immune-related myopathy including Acetylcholine receptor (AChR) antibody, Anti-MuSK (muscle-specific kinase) antibody, myositis antibody.
Virus neutralizing antibody titer
时间窗: 6 months
Virus neutralizing antibody titer of Covid-19.
Adverse events following immunization (AEFI)
时间窗: 6 months
Adverse event following immunization refers to any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine.
次要结局
未报告次要终点
研究者
Fei Xiao
Prof.Fei Xiao
First Affiliated Hospital of Chongqing Medical University