Correlates of protection against symptomatic and asymptomatic SARS-CoV-2 infection.
Correlates of protection against symptomatic and asymptomatic SARS-CoV-2 infection.
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DOI：
10.1038/s41591-021-01540-1
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发表时间：
2021-11
期刊：
影响因子：
82.9
通讯作者：
Oxford COVID Vaccine Trial Group
中科院分区：
文献类型：
--
作者：
Feng S;Phillips DJ;White T;Sayal H;Aley PK;Bibi S;Dold C;Fuskova M;Gilbert SC;Hirsch I;Humphries HE;Jepson B;Kelly EJ;Plested E;Shoemaker K;Thomas KM;Vekemans J;Villafana TL;Lambe T;Pollard AJ;Voysey M;Oxford COVID Vaccine Trial Group
COVID-19疫苗的全球供应仍然有限。对免疫反应的理解可以预测保护作用，这有助于新疫苗的快速许可。分析了英国ChAdOx 1 nCoV-19（AZD 1222）疫苗随机有效性试验的数据，以确定与SARS-CoV-2保护相关的抗体水平。在第二次接种后28天，在感染和未感染的疫苗接受者中测量结合和中和抗体。所有免疫标志物的水平较高与症状性感染的风险降低相关。疫苗对大多数Alpha有症状感染的有效率为80%（B.1.1.7）SARS-CoV-2变异体，（95% CI：108，806）结合抗体单位（BAU）/ml：和506（95% CI：135，未计算（超出数据范围）（NC））抗加标抗体和抗RBD抗体的BAU/ml，以及26（95% CI：NC，NC）国际单位（IU）/ml和247（95% CI：101，NC）假病毒和活病毒中和的标准化中和滴度（NF 50）。免疫标志物与无症状感染在5%的显著性水平上不相关。这些数据可用于使用经验证的检测方法桥接新人群，并允许将疗效估计外推至新的COVID-19疫苗。由COVID-19疫苗ChAdOx 1 nCoV-19引发的SARS-CoV-2特异性结合和中和抗体的限定水平被确定为针对症状性感染的保护的相关性。
The global supply of COVID-19 vaccines remains limited. An understanding of the immune response that is predictive of protection could facilitate rapid licensure of new vaccines. Data from a randomized efficacy trial of the ChAdOx1 nCoV-19 (AZD1222) vaccine in the United Kingdom was analyzed to determine the antibody levels associated with protection against SARS-CoV-2. Binding and neutralizing antibodies at 28 days after the second dose were measured in infected and noninfected vaccine recipients. Higher levels of all immune markers were correlated with a reduced risk of symptomatic infection. A vaccine efficacy of 80% against symptomatic infection with majority Alpha (B.1.1.7) variant of SARS-CoV-2 was achieved with 264 (95% CI: 108, 806) binding antibody units (BAU)/ml: and 506 (95% CI: 135, not computed (beyond data range) (NC)) BAU/ml for anti-spike and anti-RBD antibodies, and 26 (95% CI: NC, NC) international unit (IU)/ml and 247 (95% CI: 101, NC) normalized neutralization titers (NF50) for pseudovirus and live-virus neutralization, respectively. Immune markers were not correlated with asymptomatic infections at the 5% significance level. These data can be used to bridge to new populations using validated assays, and allow extrapolation of efficacy estimates to new COVID-19 vaccines. Defined levels of SARS-CoV-2-specific binding and neutralizing antibodies elicited by the COVID-19 vaccine ChAdOx1 nCoV-19 are identified as correlates of protection against symptomatic infection.
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