Introduction: Vaccination plays a fundamental role in mastering the COVID-19 pandemic and protecting vulnerable groups. Persons with autoimmune inflammatory rheumatic diseases (AIIRD) requiring 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-CoV-2 neutralizing antibody titers were quantified by enzyme-linked immunosorbent assay 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-CoV-2 neutralizing antibody titers were significantly lower in the AIIRD patients than healthy subjects (p < .05). There are significant differences in neutralizing antibody titers among patients suffering from rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), systemic sclerosis, and ankylosing spondylitis (p < .01-.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 SARS-CoV-2 antibody titers between subjects suffering from side effects and those who did not have. SARS-CoV-2 neutralizing antibody levels were significantly higher in subjects with a history of COVID-19 infection than seronegative individuals (p < .01-0.05). Seropositive subjects had a significant increase in the percentage of vaccine-related adverse events compared to seronegative persons (p < .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: These findings revealed that the BBIBP-CorV vaccine is effective in the development of neutralizing antibodies in immunosuppressed patients without considerable reactogenicity or induction of disease flares.
Keywords: BBIBP-CorV vaccine; adverse events; disease activity; immunogenicity; patients with AIIRD.
© 2023 The Authors. Immunity, Inflammation and Disease published by John Wiley & Sons Ltd.