Baglioni Isabella, Galli Alessia, Gatti Chiara, Tufoni Simona, Rocchi Renato, Lattanzi Federico, Toia Fabio, Santarelli Adoriano, Marcelli Stefano
Clinical Tutor - Bachelor's deegre in Nursing, ASUR Marche Area Vasta N.4.
Emergency Room, Department of Emergency Medicine, Azienda OspedalieraUniversitaria Ospedali Riuniti, Ancona, Italy.
Ig Sanita Pubbl. 2023 Jan-Feb;80(1):13-26.
COVID-19 has hit every country in the world. Almost a quarter of a billion cases and nearly 5 million deaths reported globally as of late September 2021. Compared to over 6 billion doses of COVID-19 vaccine administered, the pandemic does not seem to disappear. The duration of protective immunity is currently not defined. Primary immune responses are inevitably declining and the continuous transmission of increasingly worrying viral variants.
The primary objective of the study is to evaluate the antibody response at 120 and 180 days in employees of an hospital of Marche (Italy) who have completed the vaccination cycle with Pzifer-Biontech vaccine and to highlight the correlation with quantitative and qualitative variables. The secondary objective is to study the nature and frequency of adverse events in relation to variables such as comorbidity, age, gender, working areas and developed antibody titer.
An observational retrospective study was carried out to evaluate the antibody response at 120 and 180 days. Subjects receiving a double dose of vaccine at least 21 days apart and those receiving the second dose of the same vaccine between 18 January 2021 and 31 March 2021 shall be considered. The study included non-probability sampling of convenience. All parties have provided informed written consent to access personal and clinical data.
The sample is composed by 1.115 subjects. The results of the study reveal an important immune response detected by IgG dosage, both at 120 and 180 days after the second dose of Sars-Cov-2 vaccine mRNA BNT162b2 vaccine (Pzifer-Biontech), other than very rare exceptions. Antibody values are higher among hospital workers compared to those working in other areas, both 120 and 180 days. These values are even higher in the health professionals who provide assistance in wards with positive Covid patients, both at 120 days (p=0.06) and at 180 days; the mean values of IgG are statistically higher in direct assistance of Covid patients at 180 days(p=0.029). The most frequent adverse drug events after the second dose of vaccine were pain at the site of inoculation of the vaccine (70.7%), fatigue (35%) and arthralgia (19%). It was finally shown that people with diabetes or smokers had an average antibody response statistically lower than 120 days and 180 days from the second dose.
This study leads to the conclusion that the second dose of vaccine Sars-Cov-2 vaccine mRNA BNT162b2 vaccine allows a consistent antibody response. Further multicentric studies are needed to investigate the antibody response to vaccination Sars-Cov-2 mRNA BNT162b2.
新冠疫情已席卷全球各国。截至2021年9月下旬，全球报告了近25亿例病例，近500万人死亡。与超过60亿剂新冠疫苗的接种量相比，疫情似乎并未消失。目前尚不清楚保护性免疫的持续时间。初次免疫反应不可避免地在下降，且令人担忧的病毒变种在持续传播。
本研究的主要目的是评估意大利马尔凯大区一家医院中完成辉瑞 - 生物科技疫苗接种周期的员工在120天和180天时的抗体反应，并突出其与定量和定性变量的相关性。次要目的是研究不良事件的性质和频率与合并症、年龄、性别、工作区域及产生的抗体滴度等变量之间的关系。
开展一项观察性回顾性研究，以评估120天和180天时的抗体反应。应考虑那些至少间隔21天接受两剂疫苗接种的受试者，以及在2021年1月18日至2021年3月31日期间接受同一疫苗第二剂接种的受试者。该研究采用方便抽样的非概率抽样方法。所有参与方均已提供知情书面同意以获取个人和临床数据。
样本由1115名受试者组成。研究结果显示，除极少数例外情况外，在第二剂新冠病毒疫苗mRNA BNT162b2疫苗（辉瑞 - 生物科技）接种后的120天和180天，通过IgG定量检测到了重要的免疫反应。在120天和180天时，医院工作人员的抗体值均高于其他领域的工作人员。在为新冠阳性患者病房提供援助的医护人员中，这些值在120天（p = 0.06）和180天时更高；在180天直接照料新冠患者时，IgG的平均值在统计学上更高（p = 0.029）。第二剂疫苗接种后最常见的药物不良事件是疫苗接种部位疼痛（70.7%）、疲劳（35%）和关节痛（19%）。最终表明，糖尿病患者或吸烟者在第二剂接种后120天和180天的平均抗体反应在统计学上较低。
本研究得出结论，第二剂新冠病毒疫苗mRNA BNT162b2疫苗可产生持续的抗体反应。需要进一步开展多中心研究来调查对新冠病毒mRNA BNT162b2疫苗接种的抗体反应。
