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Immunogenicity and safety of the BBIBP-CorV vaccine in patients with autoimmune inflammatory rheumatic diseases and immunosuppressive therapy in a monocentric cohort
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  • Batool Zamani,
  • Amin Moradi Hasan-Abad,
  • Ahmad Piroozmand,
  • Mahsa Dehghani,
  • Maryam Arfaatabar,
  • Hossein Motedayyen
Batool Zamani
Kashan University of Medical Sciences
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Amin Moradi Hasan-Abad
Kashan University of Medical Sciences
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Ahmad Piroozmand
Kashan University of Medical Sciences
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Mahsa Dehghani
Kashan University of Medical Sciences
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Maryam Arfaatabar
Islamic Azad University
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Hossein Motedayyen
Kashan University of Medical Sciences

Corresponding Author:hmotedayyen@gmail.com

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Abstract

Introduction: Vaccination plays a fundamental role in mastering the COVID-19 pandemic and protecting vulnerable groups. Persons with autoimmune inflammatory rheumatic diseases (AIIRD), on immunosuppressive therapies, are prioritized for vaccination. However, data concerning immunogenicity and safety of the BBIBP-CorV vaccine in immunosuppressed patients are not found. This study presents data on the efficacy and safety of the BBIBP-CorV vaccine in immunosuppressed patients compared to healthy controls. Methods: Study population consisted of 100 healthy controls and 100 patients with AIIRD. Vaccination was performed according to national guidelines with the BBIBP-CorV vaccine. SARS-CoV2 neutralizing antibody titers were quantified by ELISA before initial vaccination and 1–3 months after secondary vaccination. Adverse events were assessed before study initiation and 7 days after the second dose. Disease activity was studied before entering the study and 3-8 weeks after the second dose. Results: Vaccination-induced positive immunogenic response rates and SARS-CoV2 neutralizing antibody titers were significantly lower in the AIIRD patients than healthy subjects (P<0.05). There are significant differences in neutralizing antibody titers among patients suffering from RA, SLE, SSc, and AS (P<0.01-0.05). The rates of seropositive vaccine responses were similarly distributed across all diseases. Healthy and AIIRD individuals had a similar profile in adverse events. No significant difference was observed in SARSCoV2 antibody titers between subjects suffering from side effects and those who did not have. SARS-CoV2 neutralizing antibody levels were significantly higher in SARS-CoV2-infected persons than noninfected subjects (P<0.01-0.05). Seropositive subjects had a significant increase in the percentage of vaccine-related adverse events compared to seronegative persons (P<0.05). Despite a minor change in the disease activity of patients with RA and SLE, disease activity indices were overall stable in the AIIRD patients. Conclusion: The BBIBP-CorV vaccine is effective in the development of neutralizing antibody in immunosuppressed patients without considerable reactogenicity or induction of disease flares.
19 Dec 2022Submitted to Immunity, Inflammation and Disease
21 Dec 2022Submission Checks Completed
21 Dec 2022Assigned to Editor
22 Dec 2022Review(s) Completed, Editorial Evaluation Pending
28 Dec 2022Reviewer(s) Assigned
19 Mar 2023Editorial Decision: Revise Major
21 Mar 20231st Revision Received
25 Mar 2023Submission Checks Completed
25 Mar 2023Assigned to Editor
25 Mar 2023Review(s) Completed, Editorial Evaluation Pending
19 Apr 2023Reviewer(s) Assigned
21 Apr 2023Editorial Decision: Accept
May 2023Published in Immunity, Inflammation and Disease volume 11 issue 5. https://doi.org/10.1002/iid3.858