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Safety and neutralization antibody levels of inactivated SARS-CoV-2 vaccine in adult patients with Myasthenia Gravis: a prospective observational cohort study

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Abstract  

Background and objectives

Myasthenia gravis (MG) is an autoimmune disease affecting the neuromuscular junction. No cohort study has investigated the efficacy of inactivated vaccines in patients with MG.

Materials and methods

This prospective observational cohort study included healthy controls (HCs) and patients with MG with or without immunosuppressive treatment. Vaccination occurred between May and December 2021. Patients with MG were subjected to a clinical scale assessment for disease severity. The neutralization antibodies (Nabs) levels were measured in all participants using the pseudovirus neutralization assay.

Results

Twenty-one patients (Female/Male:10/11); age median [interquartile range (IQR)]: 43 [30, 56]) were included in this study. Two patients (2/21) were lost during follow-up after enrollment. No sustained vaccine-related adverse effects occurred in any visit of patients with MG. No exacerbation of MG was observed. Acetylcholine receptor antibody (AChR-Ab) levels showed no statistically significant changes between the first and second visit (median [IQR]: 2.22 [0.99, 2.63] nmol/L vs. 1.54 [1.07, 2.40] nmol/L, p = 0.424). However, levels of AChR-Ab decreased at the third visit (median [IQR]: 2.22 [0.96, 2.70] nmol/L vs. 1.69 [0.70, 1.85] nmol/L, p = 0.011). No statistically significant difference in Nabs levels was found between HCs and patients with MG (median [IQR]: 102.89 [33.13, 293.86] vs. 79.29 [37.50, 141.93], p = 0.147).

Discussion

The safety of the SARS-CoV-2 inactivated vaccine was reconfirmed in this study. No significant difference in Nabs level was found between patients with MG and HCs. Nabs levels correlated with AChR-Ab levels before vaccination and ΔAChR-Ab levels.

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Data availability

The datasets for this study can be found in https://register.clinicaltrials.gov (NCT04941079).

Abbreviations

AChR-Ab :

Acetylcholine receptor antibody

ELISA :

Enzyme-Linked Immunosorbent Assay

HCs :

Healthy controls

IST :

Immunosuppressive therapy

IQR :

Interquartile range

MG :

Myasthenia gravis

MG-ADL :

MG‐activities of daily living profile

MGC :

MG‐composite

MGFA :

Myasthenia Gravis Foundation of America

MG-MMT :

MG-manual muscle test

MG-QoL15 :

MG-quality of life, Nabs neutralization antibodies QMG quantitative MG score, SARS-CoV-2 severe acute respiratory syndrome coronavirus 2

T1 :

Time interval (Days) between second dose vaccination and third visit

T2 :

Time interval (Days) between first dose vaccination and third visit

T3 :

Time interval (Days) between first dose vaccination and second dose vaccination

STROBE :

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline

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Acknowledgements

The authors wish to thank the patients, healthy controls, and the team of research assistants in the First Affiliated Hospital of Chongqing Medical University

Funding

This work was supported by Future Medical Youth Innovation Team Program of Chongqing Medical University (No. W0043), the Fifth Senior Medical Talents Program of Chongqing for Young and Middle-aged, Middle-aged Medical Excellence Team Program of Chongqing, and Chongqing chief expert studio project, China, Young and Middle-aged Medical Excellence Team Program of Chongqing, and Chongqing Talent Program (CQYC202005013).

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Authors and Affiliations

  1. Department of Neurology, the First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Neurology, Chongqing, China

    Wei Zheng, Jing Luo, Zhuoting Liu, Wenjun Que, Xia Guo, Rui Fan & Fei Xiao

  2. Key Laboratory of Molecular Biology On Infectious Diseases, Ministry of Education, Chongqing Medical University, Chongqing, China

    Xiaoxia Cao & Quanxin Long

  3. Department of Blood Transfusion, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China

    Wenjun Que

  4. Department of Neurology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, China

    Xia Guo

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  1. Wei Zheng
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Contributions

Fei Xiao, and Quanxin Long contributed to the study design, critical revision of manuscript. Wei Zheng and Xiaoxia Cao study design, patient testing, acquisition of data, statistical analysis, writing the manuscript. Jing Luo, Zhuoting Liu, Wenjun Que, Xia Guo, and Rui Fan, acquisition of data, statistical analysis.

Corresponding authors

Correspondence to Quanxin Long or Fei Xiao.

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Ethical approval

This prospective observational cohort study was performed at the First Affiliated Hospital of Chongqing Medical University and approved by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University (2021–296).

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Informed consent to participate and publication from the patient was also obtained.

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The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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Wei Zheng and Xiaoxia Cao share first authorship.

Quanxin Long and Fei Xiao share last authorship.

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Zheng, W., Cao, X., Luo, J. et al. Safety and neutralization antibody levels of inactivated SARS-CoV-2 vaccine in adult patients with Myasthenia Gravis: a prospective observational cohort study. Neurol Sci 45, 1707–1717 (2024). https://doi.org/10.1007/s10072-023-07186-w

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