PDF(Pubmed)
Abstract：
The evaluation of coronavirus disease 2019 (COVID-19) vaccine immunogenicity remains essential as the severe acute respiratory syncytial virus 2 (SARS-CoV-2) pandemic continues to evolve and as additional variants emerge. Neutralizing antibodies are a known correlate of protection for SARS-CoV-2 vaccines. A pseudovirus neutralization (PNT) assay was developed and validated at Novavax Clinical Immunology Laboratories to allow for the detection of neutralizing antibodies in vaccine clinical trial sera. The PNT assay was precise, accurate, linear, and specific in measuring SARS-CoV-2 neutralization titers in human serum for ancestral strain and the Omicron subvariants BA.5 and XBB.1.5, with an overall geometric coefficient of variation of ≤43.4%, a percent relative bias within the expected range of -60% to 150%, and a linearity value of R2 > 0.98 for all three strains. This pseudovirus assay will be useful for the analysis of vaccine clinical trial samples to assess vaccine immunogenicity. Future work will focus on modifying the assay for emerging variants, including XBB.1.16, EG.5.1, BA.2.86, and any other variants that emerge in the ongoing pandemic.
摘要：
2019年冠状病毒病（COVID-19）疫苗免疫原性的评估仍然至关重要，因为严重的急性呼吸道合胞病毒2（SARS-CoV-2）大流行继续演变，并且随着其他变体的出现。中和抗体是SARS-CoV-2疫苗的保护的已知关联。在Novavax临床免疫学实验室开发并验证了假病毒中和（PNT）测定法，以允许检测疫苗临床试验血清中的中和抗体。PNT测定是精确的，准确,线性,并且在测量祖先菌株和Omicron亚变体BA.5和XBB.1.5的人血清中SARS-CoV-2中和滴度方面具有特异性，总体几何变异系数≤43.4％，在-60%至150%的预期范围内的百分比相对偏差，所有三个菌株的线性值R2>0.98。该假病毒测定可用于分析疫苗临床试验样品以评估疫苗免疫原性。未来的工作将集中在修改新出现的变体的测定，包括XBB.1.16、EG.5.1、BA.2.86以及正在进行的大流行中出现的任何其他变体。
