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

Chongqing Medical University

Status: Unknown

Conditions: Myopathy; Covid19

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04941079

2021-296

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

Immune-related Myopathy Patient (myasthenia gravis and inflammatory myopathy)

Treatment:

Other: no intervention

Health Control

Treatment:

Other: no intervention