Immunogenicity and safety of the BBIBP-CorV vaccine in patients with
autoimmune inflammatory rheumatic diseases and immunosuppressive therapy
in a monocentric cohort
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.