Profound decline of antibody titers 6 months after BNT162b2 vaccination in healthy volunteers
Profound decline of antibody titers 6 months after BNT162b2 vaccination in healthy volunteers
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健康志愿者接种 BNT162b2 疫苗 6 个月后抗体滴度大幅下降
DOI：
10.1515/labmed-2021-0147
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发表时间：
2021
影响因子：
1.2
通讯作者：
Shinichirou Takahashi
中科院分区：
文献类型：
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作者：
Rikei Kozakai;Kuniko Hoshi;Yoshihiko Izumi;Shinichirou Takahashi
截至2021年10月初，严重急性呼吸综合征冠状病毒-2(SARS-CoV-2)已在全球感染超过2.19亿人，造成超过455万人死亡。目前正在接种几种疫苗来预防由SARS-CoV-2感染引起的2019年冠状病毒病(新冠肺炎)，包括基因疫苗[1]。虽然抗SARS-CoV-2抗体滴度的持久性仍有待阐明，但已有报道称，RNA疫苗的体液应答持续时间较短，并存在潜在的副作用[2，3]。在目前的研究中，我们检测了东北医科大学医院的健康志愿者在接种辉瑞/BioNTech BNT162b2mRNA疫苗6个月后的SARS-CoV-2抗体水平。使用一种新建立的高灵敏度、全自动化学发光酶免疫分析(CLEIA)来评估抗体效价，CLEIA旨在专门检测针对SARS-CoV-2刺突蛋白受体结合域(RBD)的Ig G或Ig M。这种新建立的基于CLEIA的检测方法，利用抗原(或抗体)结合的磁性粒子和酶标记的抗体，以化学发光为底物进行检测。这不同于传统的化学发光化合物(Acliddium)标记抗体的CLIA方法，而不是用酶联抗体。疫苗(30μg BNT162b2/Comirnaty；辉瑞/BioNtech，纽约，NY，美国)从2021年3月15日开始在东北医科大学医院接种。研究对象为41名志愿医护人员，其中女性31人，男性10人，平均年龄39.5±12.7岁。参与者在2021年3月或4月接受了第一剂BNT162b2，21天后接受了第二剂相同剂量的BNT162b2。分别在第一次接种后14、35和180天采集血清。本报告列出了180天时间点的结果。血液样本在室温下以1,690×g离心10min，血清分离并在−80°C下以两个1毫升等份保存。在研究时，所有的血清等分同时解冻以进行分析。使用SARS-CoV-2 S-Ig G(IB)试剂和SARS-CoV-2 S-Ig M(IB)试剂(日本东京)和Lumipulse L2400系统(Fujirebio)进行了CLEIA检测。免疫球蛋白和免疫球蛋白的水平以任意单位(AU)/毫升表示，并与通过量化标准的抗SARS-CoV-2 RBD抗体样本计算的截止指数相关。在本院接受两剂BNT162b2治疗的41名志愿者中，均在第一剂BNT162b2后完成6个月的随访。在接种疫苗前或接种疫苗后的随访中，没有人经历过SARS-CoV-2感染。在撰写本文时，所有41名参与者都已经完成了自第一剂BNT162b2以来为期6个月的随访。在第一次注射BNT162b2后平均182.6天(SD3.3d)采集血清样本(图1A)。第一次注射BNT162b2 180天后，平均抗RBD IgM下降了80.9%(SD 15.9%)，并恢复到基线水平(图1B)。此外，平均抗RBD免疫球蛋白抗体也下降了88.6%(SD 4.4%)(图1C)。最近，几个小组研究了疫苗接种后2-3个月体液免疫反应的持久性。Favresse等人。[4]对200名接种者进行了分析，发现在第一次接种后3个月，抗体平均下降了37.9%和44.7%(血清阴性和血清阳性者)。通讯作者：东北医科大学实验医学部Shinichiro Takahashi，日本仙台宫野区福室1-15-1，日本，电话：+81-22290-8889，电子邮件：shintakahashi@Tohoku-mpu.ac.jp Rikei Kozakai，Kuniko Hoshi和Yoshihiko Izumi，日本仙台东北医科大学医院临床实验室
As of the beginning of October 2021, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has infected over 219 million individuals worldwide and caused more than 4.55 million deaths. Several kinds of vaccines are now being administered to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection, including mRNA vaccines [1]. Short durations of humoral responses as well as potential side effects of mRNA vaccines have been reported [2, 3], although the persistence of anti-SARS-CoV-2 antibody titers remains to be clarified. In the current study, we examined levels of SARS-CoV-2 antibodies among healthy volunteers at Tohoku Medical and Pharmaceutical University Hospital 6 months following vaccination with the Pfizer/BioNTech BNT162b2 mRNA vaccine. Antibody titers were evaluated using a newly established, highly sensitive, fully automated chemiluminescent enzyme immunoassay (CLEIA) designed to specifically detect IgG or IgM against the SARS-CoV-2 spike protein receptor-binding domain (RBD). This newly established CLEIA based assay, utilizes antigen (or antibody)-bound magnetic particles and enzyme-labeled antibody, with chemiluminescent substrate for detection. That is different from conventional CLIA assay employing chemiluminescent compound (aclidinium)-labeled antibody, instead of enzyme-linked antibody. Vaccines (30 μg of BNT162b2/Comirnaty; Pfizer/BioNTech, New York, NY, USA) were administered at Tohoku Medical and Pharmaceutical University Hospital starting on 15March 2021. A total of 41 volunteer healthcareworkers (31women and 10men,mean± standard deviation [SD] age 39.5 ± 12.7 years) were enrolled in the study. Participants received a first dose of BNT162b2 in March or April 2021, followed by a second identical dose 21 days later. Sera were collected at 14, 35, and 180 days after the first vaccination. Results for the 180-day time point are presented in this report. Blood samples were centrifuged at 1,690×g for 10 min at room temperature, and sera were separated for storage at −80 °C in two 1-mL aliquots. All serum aliquots were thawed simultaneously for analysis at the time of the study. CLEIAswere conducted using SARS-CoV-2 S-IgG (IB) and SARS-CoV-2 S-IgM (IB) reagents (Fujirebio, Tokyo, Japan) and a Lumipulse L2400 system (Fujirebio). Levels of IgG and IgMwere expressed in arbitrary units (AU)/mL and evaluated in relation to a cut-off index calculated by quantification of standard anti-SARS-CoV-2 RBD antibody samples. Of 41 volunteers who received two doses of BNT162b2 at our hospital, all completed 6 months of follow-up after the first dose. None experienced SARS-CoV-2 infections prior to vaccination or during post-vaccination follow-up. At the time of writing, all 41 participants have completed 6 months of follow up since the first dose of BNT162b2. Serum samples were obtained on average 182.6 days (SD 3.3 days) after the first dose of BNT162b2 (Figure 1A). One hundred and eighty days after the first dose of BNT162b2, mean anti-RBD IgM had decreased by 80.9% (SD 15.9%) and had returned to baseline levels (Figure 1B). Additionally, mean anti-RBD IgG antibodies had also decreased by 88.6% (SD 4.4%) (Figure 1C). Recently, several groups have investigated the persistence of humoral immune responses 2–3 months after vaccination. Favresse et al. [4] analyzed 200 vaccinees and found mean antibody decreases of 37.9% and 44.7% (among seronegative and seropositive individuals, respectively) 3 months after the first vaccination. Shrotri *Corresponding author: Shinichiro Takahashi, Division of Laboratory Medicine, Tohoku Medical and Pharmaceutical University, 1-15-1, Fukumuro, Miyagino-ku, Sendai, 983-8536, Japan, Phone: +81-22290-8889, E-mail: shintakahashi@tohoku-mpu.ac.jp Rikei Kozakai, Kuniko Hoshi and Yoshihiko Izumi, Department of Clinical Laboratory, Tohoku Medical and Pharmaceutical University Hospital, Sendai, Japan J Lab Med 2021; aop
mRNA疫苗会诱导SARS-COV-2和关注的变体诱导耐用的免疫记忆。
DOI：
10.1126/science.abm0829
发表时间：
2021-12-03
期刊：
Science (New York, N.Y.)
影响因子：
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作者：
通讯作者：
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