Division of Infectious Diseases, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Division of Vaccine Development Coordination, Center for Vaccine Research, National Institute of Infectious Diseases, National Institute of Health, Korea Disease Control and Prevention Agency, Cheongju, Republic of Korea.
Front Immunol. 2023 Mar 2;14:1139980. doi: 10.3389/fimmu.2023.1139980. eCollection 2023.
The effect of tixagevimab/cilgavimab (Evusheld™; AstraZeneca, UK) should be evaluated in the context of concurrent outbreak situations.
For serologic investigation of tixagevimab/cilgavimab during the BA.5 outbreak period, sera of immunocompromised (IC) hosts sampled before and one month after tixagevimab/cilgavimab administration and those of healthcare workers (HCWs) sampled one month after a 3 shot of COVID-19 vaccines, five months after BA.1/BA.2 breakthrough infection (BI), and one month after BA.5 BI were investigated. Semi-quantitative anti-spike protein antibody (Sab) test and plaque reduction neutralizing test (PRNT) against BA.5 were performed.
A total of 19 IC hosts (five received tixagevimab/cilgavimab 300 mg and 14 received 600 mg) and 41 HCWs (21 experienced BA.1/BA.2 BI and 20 experienced BA.5 BI) were evaluated. Baseline characteristics did not differ significantly between IC hosts and HCWs except for age and hypertension. Sab significantly increased after tixagevimab/cilgavimab administration (median 130.2 BAU/mL before tixagevimab/cilgavimab, 5,665.8 BAU/mL after 300 mg, and 10,217 BAU/mL after 600 mg; both < 0.001). Sab of one month after the 3 shot (12,144.2 BAU/mL) or five months after BA.1/BA.2 BI (10,455.8 BAU/mL) were comparable with that of tixagevimab/cilgavimab 600 mg, while Sab of one month after BA.5 BI were significantly higher (22,216.0 BAU/mL; < 0.001). BA.5 PRNT ND significantly increased after tixagevimab/cilgavimab administration (median ND 29.6 before tixagevimab/cilgavimab, 170.8 after 300 mg, and 298.5 after 600 mg; both < 0.001). The ND after tixagevimab/cilgavimab 600 mg was comparable to those of five months after BA.1 BI (ND 200.9) while ND of one month after the 3 shot was significantly lower (ND 107.6; = 0.019). The ND of one month after BA.5 BI (ND 1,272.5) was highest among tested groups, but statistical difference was not noticed with tixagevimab/cilgavimab 600 mg.
Tixagevimab/cilgavimab provided a comparable neutralizing activity against the BA.5 with a healthy adult population who were vaccinated with a 3 shot and experienced BA.1/BA.2 BI.
在 BA.5 爆发期间，应当评估替沙格韦单抗/西加韦单抗（Evusheld™；阿斯利康，英国）的效果，同时应考虑到并发爆发情况。
在 BA.5 爆发期间，对免疫功能低下（IC）宿主在接受替沙格韦单抗/西加韦单抗治疗前和治疗后一个月以及在接种三剂 COVID-19 疫苗后一个月、BA.1/BA.2 突破感染（BI）后五个月以及 BA.5 BI 后一个月采集的血清进行替沙格韦单抗/西加韦单抗血清学调查。对 BA.5 进行半定量抗刺突蛋白抗体（Sab）检测和蚀斑减少中和试验（PRNT）。
共评估了 19 名 IC 宿主（5 名接受替沙格韦单抗/西加韦单抗 300mg，14 名接受 600mg）和 41 名 HCW（21 名经历了 BA.1/BA.2 BI，20 名经历了 BA.5 BI）。IC 宿主和 HCW 之间的基线特征除年龄和高血压外无显著差异。接受替沙格韦单抗/西加韦单抗治疗后 Sab 显著增加（替沙格韦单抗/西加韦单抗治疗前中位数 130.2 BAU/mL，300mg 后 5665.8 BAU/mL，600mg 后 10217BAU/mL；均 < 0.001）。三剂接种后一个月（12144.2 BAU/mL）或 BA.1/BA.2 BI 后五个月（10455.8 BAU/mL）的 Sab 与替沙格韦单抗/西加韦单抗 600mg 相当，而 BA.5 BI 后一个月的 Sab 显著更高（22216.0 BAU/mL； < 0.001）。接受替沙格韦单抗/西加韦单抗治疗后，BA.5 PRNT ND 显著增加（替沙格韦单抗/西加韦单抗治疗前中位数 ND 29.6，300mg 后 170.8，600mg 后 298.5；均 < 0.001）。替沙格韦单抗/西加韦单抗 600mg 后的 ND 与 BA.1 BI 后五个月的 ND（200.9）相当，而三剂接种后一个月的 ND 显著较低（ND 107.6； = 0.019）。BA.5 BI 后一个月的 ND（ND 1272.5）在检测组中最高，但与替沙格韦单抗/西加韦单抗 600mg 相比，未观察到统计学差异。
替沙格韦单抗/西加韦单抗在接种三剂并经历了 BA.1/BA.2 BI 的健康成年人群中对 BA.5 提供了相当的中和活性。
