Immunity, inflammation and disease · 2023
Immunogenicity and safety of the BBIBP-CorV vaccine in patients with autoimmune inflammatory rheumatic diseases undergoing immunosuppressive therapy in a monocentric cohort.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Zamani Batool, Moradi Hasan-Abad Amin, Piroozmand Ahmad, Dehghani Mahsa, Arfaatabar Maryam, Motedayyen Hossein
Аннотация
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.
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.