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

Sponsor
First Affiliated Hospital of Chongqing Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04941079
Collaborator
(none)
70
Enrollment
6
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
70 participants
Observational Model:
Other
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Jun 30, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Immune-related Myopathy Patient (myasthenia gravis and inflammatory myopathy)

Other: no intervention
no intervention
Health Control

Other: no intervention
no intervention

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. Virus neutralizing antibody titer [6 months]

    Virus neutralizing antibody titer of Covid-19.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • First Affiliated Hospital of Chongqing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fei Xiao, Prof.Fei Xiao, First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT04941079
Other Study ID Numbers:
  • 2021-296
First Posted:
Jun 28, 2021
Last Update Posted:
Jun 28, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myasthenia Gravis
Muscular Diseases
Myositis

Study Results

No Results Posted as of Jun 28, 2021