Medical Oncology 1 Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
Microbiology and Virology Unit, Dermatological Clinical Department, IRCCS San Gallicano Dermatological Institute, Italy.
Eur J Cancer. 2022 Apr;165:169-173. doi: 10.1016/j.ejca.2022.01.011. Epub 2022 Mar 1.
We previously reported on the immunogenicity and safety of BNT162b2 in a large cohort of patients with cancer after the first and second doses (Di Noia et al., 2021) [1]. Herein, we present result after six months of follow-up.
This prospective study included patients affected by solid tumors and afferent to our institution who received two doses of BNT162b2 vaccine. A cohort of vaccinated healthcare workers (HCW) was used as control-group. Both cohorts were evaluated for the titer of anti-Spike (S) IgG at prefixed time-points (TPs). Time-point 4 was scheduled at 24-26 weeks after the second dose.
In the current analysis, 400 patients and 232 healthcare workers were evaluated. Responders (IgG > 15 AU/mL) in patients group were 86.5% compared with 94.4% among healthcare workers. Also the IgG titer at TP4 was significantly inferior in patients than in healthcare workers (70.81 vs 134.64 AU/ml, p < 0.001). There was a more rapid decline of the antibody level from TP3 to TP4 in patients than in healthcare workers (1.78 vs 1.3 fold). The estimated IgG half-life was significantly shorter for patients (73 days) than in healthcare workers (118 days) as well as the time to reach negative serological status (340 vs 532 days).
The decline of humoral response to the vaccine observed in patients with solid cancer after six months from the first dose support the urgent need of an early additional dose.
我们之前报道了首剂和第二剂后，在一大群癌症患者中 BNT162b2 的免疫原性和安全性（Di Noia 等人，2021 年）[1]。在此，我们介绍了 6 个月随访后的结果。
本前瞻性研究纳入了接受两剂 BNT162b2 疫苗的实体瘤患者和我们机构的患者。接种医护人员（HCW）的队列被用作对照组。两个队列均在固定时间点（TP）评估抗刺突（S）IgG 滴度。时间点 4 计划在第二剂后 24-26 周进行。
在本次分析中，评估了 400 名患者和 232 名医护人员。患者组的应答者（IgG > 15 AU/mL）为 86.5%，而医护人员组为 94.4%。此外，患者组在时间点 4 的 IgG 滴度明显低于医护人员组（70.81 与 134.64 AU/ml，p < 0.001）。患者组从时间点 3 到时间点 4 的抗体水平下降速度明显快于医护人员组（1.78 倍与 1.3 倍）。患者的 IgG 半衰期明显短于医护人员（73 天与 118 天），达到阴性血清学状态的时间也短（340 天与 532 天）。
从首剂后 6 个月观察到实体瘤患者对疫苗的体液反应下降，支持急需早期额外剂量。
