SCVSA Department, University of Parma, Parma, Italy.
Liver Unit, Department of Medical Sciences, IRCCS Fondazione, "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Italy.
Clin Chem Lab Med. 2021 Oct 7;59(12):2019-2026. doi: 10.1515/cclm-2021-0364. Print 2021 Nov 25.
After exceptional research efforts, several vaccines were developed against SARS-CoV-2 which sustains the pandemic COVID-19. The Comirnaty vaccine showed high efficacy in clinical trials and was the first to be approved for its distribution to the general population. We evaluated the immune response induced by the first vaccine dose in different sex/age groups and subjects with or without naturally present anti-SARS-CoV-2 antibodies.
As part of an Italian multicenter project (), serum samples from 4,290 health-professionals were serologically tested the day of the first vaccination dose, and 21 days later, using two different instrumentations (Siemens-Healthineers and Roche).
In total, 97% of samples showed the presence of specific antibodies 21 days after the vaccination dose; the percentage of non-responders increased with age in both genders. Remarkably, naturally seropositive individuals showed antibody persistence up to 11 months and an exceptionally higher vaccination response compared to subjects never infected by SARS-CoV-2.
This study highlighted the importance of the serological test i) to identify naturally SARS-CoV-2 seropositive individuals and ii) to evaluate the antibody level elicited by the first vaccination dose. Both tests, highlighted differences in the immune response, when subjects were stratified by sex and age, and between naturally seropositive and seronegative subjects. The data obtained show how serological tests could play a crucial role in the triage of the population subjected to the vaccination campaign for COVID-19. The definition of suitable instrumentation-specific thresholds is needed to correctly follow eventually acquired post-vaccination immunity in the general population.
经过非凡的研究努力，针对持续大流行的 COVID-19 的 SARS-CoV-2 开发了几种疫苗。Comirnaty 疫苗在临床试验中显示出了很高的疗效，并且是第一个被批准用于向普通人群分发的疫苗。我们评估了不同性别/年龄组、以及是否具有天然存在的抗 SARS-CoV-2 抗体的个体中第一剂疫苗引起的免疫反应。
作为意大利多中心项目的一部分（），在接种第一剂疫苗的当天，使用两种不同的仪器（西门子-Healthineers 和罗氏）对 4290 名卫生专业人员的血清样本进行了血清学检测，21 天后再次进行检测。
总共，97%的样本在接种疫苗 21 天后显示出存在特异性抗体；在两性中，随着年龄的增长，无应答者的比例增加。值得注意的是，自然血清阳性个体的抗体持续存在长达 11 个月，并且与从未感染过 SARS-CoV-2 的个体相比，疫苗反应异常高。
本研究强调了血清学检测的重要性：i）识别自然 SARS-CoV-2 血清阳性个体，ii）评估第一剂疫苗引起的抗体水平。当根据性别和年龄对受试者进行分层，以及在自然血清阳性和血清阴性个体之间进行分层时，这两种检测方法都突出了免疫反应的差异。获得的数据表明，血清学检测如何在对 COVID-19 疫苗接种运动中的人群进行分类中发挥关键作用。需要定义适合特定仪器的阈值，以正确跟踪普通人群中最终获得的接种后免疫。
