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NCT04941079 Clinical Trial

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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04941079
Other study ID # 2021-296
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 30, 2021
Est. completion date December 31, 2021

Study information
Verified date June 2021
Source First Affiliated Hospital of Chongqing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 70
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
no intervention

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital of Chongqing Medical University

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Virus neutralizing antibody titer Virus neutralizing antibody titer of Covid-19. 6 months
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