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

NCT04941079 | Unknown

• 1 other identifier: 2021-296
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19; Myopathy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

Other: no intervention

Health Control

Other: no intervention

Interventions

no intervention OTHER

no intervention

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

MeSH Terms

Conditions

COVID-19; Muscular Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Fei Xiao

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: June 28, 2021
• Study Start: June 30, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 28, 2021

Record last verified: 2021-06