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

• Conditions: Covid19; Myopathy
• Interventions: Other: no intervention

• Registration Number: NCT04941079
• Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-06-24
• Last Update Submitted: 2021-06-24
• Study First Posted: 2021-06-28
• Last Update Posted: 2021-06-28
• Study Start: 2021-06-30
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Complete behavioral ability
2. Voluntary willingness to vaccinate
3. Clinically confirmed immune-related myopathy (myasthenia gravis and inflammatory myopathy) and immune-related myopathy (myasthenia gravis and inflammatory myopathy)was stable
4. Informed consent to the research

Exclusion Criteria

1. No independent behavior ability
2. Vaccination is contraindicated
3. Other diseases that significantly affect the immune function
4. Other diseases that may significantly affect immune function are being treated
5. Vaccination contraindication was found during the study observation period
6. Other diseases that may significantly affect immune function were diagnosed during the study observation period
7. Treatments for other diseases that may significantly affect immune function were initiated during the study observation period
8. Refused regular follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Health Control	no intervention	-
Immune-related Myopathy Patient (myasthenia gravis and inflammatory myopathy)	no intervention	-

Primary Outcome Measures

Name	Time	Method
Serum specific antibody	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	6 months	Virus neutralizing antibody titer of Covid-19.
Adverse events following immunization (AEFI)	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.