Department of Oncology and Hemato-Oncology, Università degli Studi di Milano, Milan, Italy; Chemical-Clinical and Microbiological Analyses, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Department of Oncology and Hemato-Oncology, Università degli Studi di Milano, Milan, Italy; Chemical-Clinical and Microbiological Analyses, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Mayo Clin Proc. 2021 Dec;96(12):2966-2979. doi: 10.1016/j.mayocp.2021.08.013. Epub 2021 Aug 30.
To evaluate the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) anti-spike (S) IgG antibody production after vaccination with BNT162b2 and the protection from symptomatic breakthrough infections in health care workers.
This prospective observational study (RENAISSANCE) had as a primary end point the evaluation of serologic response to BNT162b2 14 days after a second dose. SARS-CoV-2 anti-S IgG antibodies were evaluated with LIAISON SARS-CoV-2 TrimericS IgG assay (DiaSorin S.p.A.), which is able to detect the presence of both binding and neutralizing antibodies for trimeric spike glycoprotein. Participants were recruited from February 1, 2021, to February 22, 2021. Occurrence of vaccine breakthrough infections was assessed by reverse transcription-polymerase chain reaction on symptomatic and contact cases up to June 6, 2021.
Of 2569 staff evaluated, only 4 were nonresponders (0.16%; 95% CI, 0.04% to 0.41%). All 4 nonresponders were severely immunosuppressed and receiving treatment with mycophenolate mofetil or mycophenolic acid. At 14 days after the second dose, 67.5% (1733) of staff had anti-S IgG titers of 2000 BAU/mL or higher; 19.2% (494), between 1500 and 2000 BAU/mL; 9.8% (251), between 1000 and 1500 BAU/mL; and 3.4% (87), 1000 BAU/mL or lower. Women had a higher probability of having higher titers than men (64.5% [1044/1618] vs 58.3% [410/703]; P=.005). This was confirmed after adjustment for age group (odds ratio, 1.275; 95% CI, 1.062 to 1.531; P=.009). Four months after the end of the vaccination program, only 13 participants (0.26%) had experienced a breakthrough SARS-CoV-2 infection, including 1 nonresponder. This was the only participant requiring hospitalization for severe COVID-19.
The vaccination campaign among health care workers at the ASST GOM Niguarda has resulted in a marked serologic response and reduction of incident COVID-19 cases. Yet, the lack of protection should not be overlooked in immunocompromised individuals.
评估接种 BNT162b2 后严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）刺突（S）IgG 抗体的产生情况，并评估其对卫生保健工作者出现有症状突破性感染的保护作用。
这项前瞻性观察研究（RENAISSANCE）的主要终点是评估第二剂后 14 天的血清学反应。使用 LIAISON SARS-CoV-2 三聚体 S IgG 检测试剂盒（DiaSorin S.p.A.）评估 SARS-CoV-2 抗 S IgG 抗体，该试剂盒能够检测到三聚体刺突糖蛋白的结合和中和抗体的存在。参与者于 2021 年 2 月 1 日至 2021 年 2 月 22 日招募。截至 2021 年 6 月 6 日，通过对有症状和接触病例进行逆转录-聚合酶链反应评估疫苗突破性感染的发生情况。
在评估的 2569 名工作人员中，仅有 4 人（0.16%；95%CI，0.04%至 0.41%）为无应答者。所有 4 名无应答者均严重免疫抑制，并接受霉酚酸酯或霉酚酸治疗。第二剂后 14 天，67.5%（1733 人）的工作人员 SARS-CoV-2 抗 S IgG 滴度达到 2000 BAU/mL 或更高；19.2%（494 人）为 1500 至 2000 BAU/mL；9.8%（251 人）为 1000 至 1500 BAU/mL；3.4%（87 人）为 1000 BAU/mL 或更低。女性比男性更有可能出现更高滴度（64.5%[1044/1618]比 58.3%[410/703]；P=0.005）。这一结果在按年龄组调整后得到了证实（比值比，1.275；95%CI，1.062 至 1.531；P=0.009）。接种计划结束 4 个月后，仅有 13 名参与者（0.26%）经历了 SARS-CoV-2 突破性感染，其中包括 1 名无应答者。这是唯一需要因重症 COVID-19 住院的参与者。
ASST GOM Niguarda 的卫生保健工作者疫苗接种活动导致了明显的血清学反应和 COVID-19 病例的减少。然而，在免疫功能低下的个体中，不应忽视缺乏保护作用的情况。
