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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immune-related Myopathy Patient (myasthenia gravis and inflammatory myopathy) |
| ||
| Health Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | no intervention |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Immune-related myopathy (myasthenia gravis and inflammatory myopathy) patients and health controls who are willing to receive two dose of SARS-CoV-2 inactivated vaccine.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 1, 2022 | |
| Reset | Apr 11, 2022 | |
| Release | May 6, 2022 |
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| Reset | Feb 3, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 1, 2022 | Apr 11, 2022 | |||
| May 6, 2022 | Feb 3, 2023 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D009135 | Muscular Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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