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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04941079

Enrollment

Registered

2021-06-28

Start date

2021-06-30

Completion date

2021-12-31

Last updated

2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Myopathy

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.

Interventions

OTHERno intervention

no intervention

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026