两种免疫分析法检测 BNT162b2 疫苗接种后健康成年人长达 6 个月的抗 SARS-CoV-2 抗体效价的动力学：日本的一项前瞻性队列研究。
Kinetics of anti-SARS-CoV-2 antibody titer in healthy adults up to 6 months after BNT162b2 vaccination measured by two immunoassays: A prospective cohort study in Japan.
机构信息
Department of Public Health, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan; Research Center for Infectious Disease Sciences, Graduate School of Medicine, Osaka Metropolitan University, Japan.
Department of Public Health, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan; Research Center for Infectious Disease Sciences, Graduate School of Medicine, Osaka Metropolitan University, Japan.
出版信息
Vaccine. 2022 Sep 9;40(38):5631-5640. doi: 10.1016/j.vaccine.2022.08.018. Epub 2022 Aug 15.
BACKGROUND
Although several assays are used to measure anti-receptor-binding domain (RBD) antibodies induced after severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccination, the assays are not fully comparable in practice. This study evaluated the immunogenicity of the BNT162b2 mRNA vaccine in healthy adults using two immunoassays.
METHODS
This prospective cohort study included SARS-CoV-2-naïve adults, predominantly healthcare workers, aged 20-64 years, who received two BNT162b2 vaccine doses between March and May 2021. Blood samples were collected before the first vaccination (S0), before the second vaccination (S1), 4 weeks after the second vaccination (S2), and 6 months after the second vaccination (S3). anti-RBD antibodies were measured using the Architect SARS-CoV-2 IgG II Quant (Abbott Laboratory) and Elecsys anti-SARS-CoV-2 S (Roche Diagnostics) assays.
RESULTS
Among the 385 participants, the geometric mean antibody titers (GMTs) on the Architect assay (AU/mL) were 7.5, 693, 7007, and 1030 for S0, S1, S2, and S3, respectively. The corresponding GMTs on the Elecsys assay (U/mL) were 0.40, 24, 928, and 659, respectively. The GMT ratio (S3/S2) was 0.15 on the Architect and 0.71 on the Elecsys assay. The correlation between antibody titers measured with the two assays were strong at all time points after vaccination (Spearman's correlation coefficient: 0.74 to 0.86, P < 0.01 for all). GMT was significantly lower in the older age group after vaccination (P < 0.01), with no significant differences according to sex. Seroprotection (≥5458 AU/mL on the Architect assay and ≥ 753 U/mL on the Elecsys) at each time point was 0 %, 1 %, 67 %, and 1 % on the Architect assay and 0 %, 1 %, 62 %, and 43 % on the Elecsys, respectively.
CONCLUSIONS
Two BNT162b2 vaccine doses resulted in adequate anti-RBD antibody response, which varied by age. As the two assays showed different kinetics, the results of single immunoassays should be interpreted with caution.
背景
尽管有几种检测方法可用于测量接种严重急性呼吸综合征冠状病毒 2 型（SARS-CoV-2）疫苗后产生的抗受体结合域（RBD）抗体，但实际上这些检测方法并不完全可比。本研究使用两种免疫测定法评估了 BNT162b2 mRNA 疫苗在健康成年人中的免疫原性。
方法
这项前瞻性队列研究纳入了 SARS-CoV-2 -naive 成年人，主要是医护人员，年龄在 20-64 岁之间，他们在 2021 年 3 月至 5 月之间接受了两剂 BNT162b2 疫苗。在第一次接种疫苗前（S0）、第二次接种疫苗前（S1）、第二次接种疫苗后 4 周（S2）和第二次接种疫苗后 6 个月（S3）采集血样。使用 Architect SARS-CoV-2 IgG II Quant（雅培实验室）和 Elecsys anti-SARS-CoV-2 S（罗氏诊断公司）测定法检测抗-RBD 抗体。
结果
在 385 名参与者中，Architect 检测法（AU/mL）的抗体几何平均滴度（GMT）分别为 S0 时的 7.5、S1 时的 693、S2 时的 7007 和 S3 时的 1030。Elecsys 检测法（U/mL）的相应 GMT 分别为 0.40、24、928 和 659。Architect 检测法的 GMT 比值（S3/S2）为 0.15，Elecsys 检测法为 0.71。接种疫苗后所有时间点的抗体滴度测定值之间的相关性均较强（Spearman 相关系数：所有时间点均为 0.74 至 0.86，P<0.01）。接种疫苗后，年龄较大的年龄组 GMT 明显较低（P<0.01），但性别之间无显著差异。在每个时间点，Architect 检测法中血清保护率（≥5458 AU/mL）为 0%、1%、67%和 1%，Elecsys 检测法中血清保护率为 0%、1%、62%和 43%。
结论
两剂 BNT162b2 疫苗接种可引起足够的抗 RBD 抗体反应，但反应程度因年龄而异。由于两种检测方法的动力学不同，因此应谨慎解释单次免疫测定的结果。
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