Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial.
Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial.
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DOI：
10.1126/science.abm3425
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发表时间：
2022-01-07
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症状性COVID-19感染可以通过严重急性呼吸道综合征冠状病毒2（SARS-CoV-2）疫苗预防。“保护相关物”是一种分子生物标志物，用于测量对抗感染所需的免疫力，是全球免疫计划成功的关键。吉尔伯特等人确定抗体是参与Moderna COVE 3期临床试验的接种个体的保护相关物（参见Openshaw的Perspective）。通过测量针对病毒刺突蛋白的结合和中和抗体，作者发现这两种抗体的水平与疫苗效力的程度相关。抗体水平越高，信使RNA（mRNA）疫苗提供的保护作用越大。因此，预测mRNA疫苗效力的抗体水平可用于指导疫苗方案的修改，并支持更广泛人群的监管批准。-PNK SARS-CoV-2结合和中和抗体与Moderna mRNA COVID-19疫苗的疫苗效力和保护程度相关。在冠状病毒疗效（COVE）3期临床试验中，评估了疫苗接种者的中和和结合抗体，作为COVID-19疾病风险的相关因素和保护的相关因素。在第二次接种疫苗时和4周后测量这些免疫标志物，并以标准化的世界卫生组织国际单位报告数值。所有标志物均与COVID-19风险呈负相关，并与疫苗有效性直接相关。接种后50%中和滴度10、100和1000的疫苗接种者，估计疫苗效力分别为78%（95%置信区间，54 - 89%）、91%（87 - 94%）和96%（94 - 98%）。这些结果有助于确定与保护相关的免疫标记物，并可能指导信使RNA（mRNA）COVID-19疫苗和其他COVID-19疫苗的批准决策。
Symptomatic COVID-19 infection can be prevented by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. A “correlate of protection” is a molecular biomarker to measure how much immunity is needed to fight infection and is key for successful global immunization programs. Gilbert et al. determined that antibodies are the correlate of protection in vaccinated individuals enrolled in the Moderna COVE phase 3 clinical trial (see the Perspective by Openshaw). By measuring binding and neutralizing antibodies against the viral spike protein, the authors found that the levels of both antibodies correlated with the degree of vaccine efficacy. The higher the antibody level, the greater the protection afforded by the messenger RNA (mRNA) vaccine. Antibody levels that predict mRNA vaccine efficacy can therefore be used to guide vaccine regimen modifications and support regulatory approvals for a broader spectrum of the population. —PNK SARS-CoV-2 binding and neutralizing antibodies correlate with the degree of vaccine efficacy and protection for the Moderna mRNA COVID-19 vaccine. In the coronavirus efficacy (COVE) phase 3 clinical trial, vaccine recipients were assessed for neutralizing and binding antibodies as correlates of risk for COVID-19 disease and as correlates of protection. These immune markers were measured at the time of second vaccination and 4 weeks later, with values reported in standardized World Health Organization international units. All markers were inversely associated with COVID-19 risk and directly associated with vaccine efficacy. Vaccine recipients with postvaccination 50% neutralization titers 10, 100, and 1000 had estimated vaccine efficacies of 78% (95% confidence interval, 54 to 89%), 91% (87 to 94%), and 96% (94 to 98%), respectively. These results help define immune marker correlates of protection and may guide approval decisions for messenger RNA (mRNA) COVID-19 vaccines and other COVID-19 vaccines.