Abstract
Objective This study assessed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody responses to the BNT162b2 mRNA vaccine in Japanese healthcare workers. Methods In this prospective cohort study, participants received two doses of the BNT162b2 mRNA vaccine on days 0 and 21 and provided blood for anti-SARS-CoV-2 antibody testing before the first vaccine and on days 21 and 35 after vaccination. Anti-spike protein immunoglobulin G (S-IgG) was measured using Abbott and Fujirebio chemiluminescent immunoassays. Patients One hundred healthcare workers (median age: 39 years old, interquartile range: 30-48 years old), including 6 who had been previously infected with SARS-CoV-2 and 3 individuals taking immunosuppressive drugs, participated in the study. Results The S-IgG antibody titers (AU/mL) measured using both the Abbott and Fujirebio assays increased significantly (p<0.001) over time, both with a prevalence of 100% at 35 days after the first vaccination. The multivariate log-normal linear regression analysis indicated the effect of immunosuppressant medication using both the Abbott (p=0.013) and Fujirebio (p=0.039) assays on S-IgG levels after complete vaccination. Pearson’s correlation coefficient between the Abbott and Fujirebio S-IgG results in all 300 samples collected before and after vaccination and 50 positive controls from patients with coronavirus disease 2019 were 0.963 [95% confidence interval (CI): 0.954-0.970, p<0.001] and 0.909 (95% CI: 0.845-0.948, p<0.001), respectively. Conclusion The BNT162b2 mRNA vaccine was effective at increasing S-IgG levels in Japanese immunocompetent healthcare workers. The Fujirebio S-IgG assay showed high diagnostic accuracy, using the Abbott S-IgG assay as the reference test.
Keywords: BNT162b2 mRNA vaccine; anti-spike protein immunoglobulin G; coronavirus disease 2019; immunoglobulin; neutralizing antibody; severe acute respiratory syndrome coronavirus 2.
【저자키워드】 severe acute respiratory syndrome coronavirus 2, neutralizing antibody, Coronavirus disease 2019, Immunoglobulin, BNT162b2 mRNA vaccine, anti-spike protein immunoglobulin G, 【초록키워드】 coronavirus disease, SARS-CoV-2, Vaccine, coronavirus, vaccination, Antibody Response, diagnostic, prospective cohort study, healthcare worker, immunosuppressive drugs, Prevalence, immunoassays, Protein, anti-SARS-CoV-2 antibody, Accuracy, healthcare, Patient, Antibody titer, Neutralizing, Japanese, medication, Blood, Anti-spike, BNT162b2 mRNA, dose, Abbott, confidence interval, acute respiratory syndrome, reference test, individual, Linear regression analysis, participant, Fujirebio, positive control, first vaccination, Pearson, correlation coefficient, Complete, objective, effective, Result, was measured, collected, significantly, indicated, provided, median, infected with SARS-CoV-2, interquartile, participated, 【제목키워드】 Immunoglobulin G, Immunoglobulin, response, BNT162b2 mRNA, worker,