Six‐month longitudinal antibody kinetics of mRNA COVID‐19 vaccines

IF 1.2 Q4 IMMUNOLOGY
L. Suresh
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引用次数: 1

Abstract

To the Editor, Since the sequence for the COVID‐19 virus was made available in January 2020, vaccines have been developed and approved at an astonishing speed. The long‐term vaccine efficacy of messenger RNA (mRNA) vaccines and antibody dynamics is yet to be clearly elucidated. Understanding the antibody kinetics and dynamics, particularly in infection‐naive individuals, is necessary to assess the need for booster doses. In one of the first studies correlating antibody levels and titers, a significant trend of declining spike antibody levels was seen with time for BNT162b2 (Pfizer). This trend remained consistent when results were stratified by sex, age, and clinical vulnerability. In another study, the data from Israel, of 1.3 million people vaccinated between January and April 2021 with BNT162b2 were analyzed for correlation between time‐ from‐vaccine and afforded protection against SARS‐CoV‐2 infection. The study found that the subjects vaccinated in January and February 2021 were 53% more likely to test positive for SARS‐CoV‐2 compared with people vaccinated in March and April. Subjects who were vaccinated in January 2021 had a 2.26‐fold increased risk for breakthrough infection compared to individuals who were vaccinated in April 2021. In a recent study a 6‐month follow‐up on the BNT162b2 vaccine showed that on average, the vaccine efficacy declined by approximately 6% every 2 months. Ibarrondo et al., reported that there was an average decline of antibody titers of approximately 90% in 3 months postinfection or vaccination. Naber et al., reported that BNT162b2 vaccinated individuals demonstrated a significant decline in antibody levels 6 weeks after the second dose. Our study (Conforms to US Federal Policy for the Protection of Human Subjects) of 100 subjects who were vaccinated with either BNT162b2 or mRNA‐1273 (Moderna), the serum samples were collected at Day 0 (prevaccination), Day 42 (14 days after second vaccine dose), and Day 180 (6 months after first vaccine dose). Subjects with prior exposure to COVID‐19, positive polymerase chain reaction (PCR) test, or elevated nucleocapsid antibodies on a Total nucleocapsid antibody kit (Bio‐Rad) on Day 0 were excluded from the study. The only subject who was not infected by SARS‐CoV‐2 (negative PCR; negative for total nucleocapsid antibodies on Day 0) and who completed the vaccine doses, had blood draws at Day 0, 42, and 180 were included in the study. Antibody against COVID‐19 spike protein was measured using COVID‐19 Antibody Chemiluminescence Immunoassay (Kangrun Biotech, Guangzhou, China and validated by KSL Diagnostics Inc., Buffalo, New York and approved under emergency use authorization). A cut‐off index (COI) value of <0.8 is considered as negative for antibodies, 0.8–1.0 as indeterminate, and >1.0 is considered positive. Of the 100 subjects, 13 had received mRNA‐1273 and 87 received the BNT162b2 vaccine. Of the 100 subjects, there was a 71% drop in average immunoglobulin G antibody values from Day 45 (fully vaccinated) (41.8 ± 18.2 COI) to Day 180 (12.2 ± 17.6). When broken down by age group, the older age group (>65 years) tends to decrease less (53% drop) from fully vaccinated (29.0 ± 20.7) to 6 months (13.8 ± 27.4) (Table 1). But this smaller drop in antibody value is probably due to the weaker initial antibody response with this older age group. The younger age groups follow the pattern of the entire group more closely, with the youngest group (18–40 years) showing the strongest antibody response. Seven subjects with positive antibodies at Day 45 became negative or indeterminate at Day 180, and six of seven were >65 years old. The drop in titer values over 180 days averaged at between 69% and 72% between the two vaccine manufacturers. There was no significant difference in the antibody values between the two vaccine manufacturers. Our study adds to the emerging data pointing to waning vaccine‐induced immunity levels and the possible need for booster vaccination based on the measurement of antibody levels. While routine monitoring of COVID‐19 antibody levels and booster vaccine doses
mRNA COVID - 19疫苗的六个月纵向抗体动力学
自2020年1月提供COVID - 19病毒序列以来,疫苗以惊人的速度开发和批准。信使RNA (mRNA)疫苗的长期疫苗效力和抗体动力学尚不清楚。了解抗体动力学和动力学,特别是在初次感染的个体中,对于评估是否需要加强剂量是必要的。在一项将抗体水平和滴度联系起来的初步研究中,BNT162b2(辉瑞)的峰值抗体水平随着时间的推移呈显著下降趋势。当结果按性别、年龄和临床易感性分层时,这一趋势保持一致。在另一项研究中,研究人员分析了以色列在2021年1月至4月期间接种了BNT162b2疫苗的130万人的数据,以确定疫苗接种时间与预防SARS - CoV - 2感染之间的相关性。该研究发现,与3月和4月接种疫苗的人相比,2021年1月和2月接种疫苗的受试者检测出SARS - CoV - 2阳性的可能性要高53%。与2021年4月接种疫苗的个体相比,2021年1月接种疫苗的受试者发生突破性感染的风险增加了2.26倍。在最近的一项研究中,对BNT162b2疫苗进行了为期6个月的随访,结果显示,疫苗效力平均每2个月下降约6%。Ibarrondo等人报道,在感染或接种疫苗后3个月内,抗体滴度平均下降约90%。Naber等人报道,接种了BNT162b2疫苗的个体在第二次接种后6周抗体水平显著下降。我们的研究(符合美国联邦保护人类受试者政策)对100名接种了BNT162b2或mRNA - 1273 (Moderna)疫苗的受试者进行了研究,在第0天(预防接种)、第42天(第二次疫苗接种后14天)和第180天(第一次疫苗接种后6个月)收集了血清样本。先前暴露于COVID - 19、聚合酶链反应(PCR)检测阳性或第0天总核衣壳抗体试剂盒(Bio - Rad)中核衣壳抗体升高的受试者被排除在研究之外。唯一未被SARS - CoV - 2感染的受试者(PCR阴性;在第0天总核衣壳抗体呈阴性),并完成疫苗剂量,在第0、42和180天抽血纳入研究。针对COVID - 19刺突蛋白的抗体使用COVID - 19 Antibody Chemiluminescence Immunoassay(中国广州康润生物技术公司,经纽约布法罗KSL Diagnostics公司验证,并经紧急使用授权批准)检测。截断指数(COI)值为1.0被认为是阳性的。在100名受试者中,13人接种了mRNA - 1273, 87人接种了BNT162b2疫苗。在100名受试者中,从第45天(完全接种)(41.8±18.2 COI)到第180天(12.2±17.6),平均免疫球蛋白G抗体值下降了71%。按年龄组划分,年龄较大的年龄组(>65岁)从完全接种疫苗(29.0±20.7)到6个月(13.8±27.4),抗体值下降幅度较小(下降53%)(表1)。但抗体值下降较小可能是由于年龄较大的年龄组初始抗体反应较弱。较年轻的年龄组更接近整个组的模式,最年轻的组(18-40岁)表现出最强的抗体反应。7名在第45天抗体阳性的受试者在第180天变为阴性或不确定,7人中有6人年龄>65岁。两家疫苗生产商180天内滴度值的平均下降幅度在69%至72%之间。两家疫苗生产商的抗体值无显著差异。我们的研究增加了新的数据,指出疫苗诱导的免疫水平正在下降,可能需要基于抗体水平的测量来加强疫苗接种。同时常规监测COVID - 19抗体水平和加强疫苗剂量
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