Safety and Efficacy of Inactivated SARS-CoV-2 Vaccine in Immune-related Myopathy (Myasthenia Gravis and Inflammatory Myopathy) Patients ：a Prospective Observational Study

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Inactivated SARS-CoV-2 Vaccine in Immune-related Myopathy (Myasthenia Gravis and Inflammatory Myopathy) Patients ：a Prospective Observational Study

Conditions
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Covid19, Myopathy

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immune-related Myopathy Patient (myasthenia gravis and inflammatory myopathy)<br> | Other: no intervention<br>* no intervention<br>|
| Health Control<br> | Other: no intervention<br>* no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events following immunization (AEFI) | 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. | 6 months | 
| Serum specific antibody | Serum specific antibody of immune-related myopathy including Acetylcholine receptor (AChR) antibody, Anti-MuSK (muscle-specific kinase) antibody, myositis antibody. | 6 months | 
| Virus neutralizing antibody titer | Virus neutralizing antibody titer of Covid-19. | 6 months |