Huang Yunda, Borisov Oleg, Kee Jia Jin, Carpp Lindsay N, Wrin Terri, Cai Suqin, Sarzotti-Kelsoe Marcella, McDanal Charlene, Eaton Amanda, Pajon Rolando, Hural John, Posavad Christine M, Gill Katherine, Karuna Shelly, Corey Lawrence, McElrath M Juliana, Gilbert Peter B, Petropoulos Christos J, Montefiori David C
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
medRxiv. 2021 Sep 14:2021.09.09.21263049. doi: 10.1101/2021.09.09.21263049.
Vaccine-induced neutralizing antibodies (nAbs) are key biomarkers considered to be associated with vaccine efficacy. In United States Government-sponsored phase 3 efficacy trials of COVID-19 vaccines, nAbs are measured by two different validated pseudovirus-based SARS-CoV-2 neutralization assays, with each trial using one of the two assays. Here we describe and compare the nAb titers obtained in the two assays. We observe that one assay consistently yielded higher nAb titers than the other when both assays were performed on the World Health Organization’s anti-SARS-CoV-2 immunoglobulin International Standard, COVID-19 convalescent sera, and mRNA-1273 vaccinee sera. To overcome the challenge this difference in readout poses in comparing/combining data from the two assays, we evaluate three calibration approaches and show that readouts from the two assays can be calibrated to a common scale. These results may aid decision-making based on data from these assays for the evaluation and licensure of new or adapted COVID-19 vaccines.
疫苗诱导的中和抗体（nAbs）是被认为与疫苗效力相关的关键生物标志物。在美国政府资助的新冠病毒疫苗3期效力试验中，nAbs通过两种不同的经过验证的基于假病毒的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）中和试验进行测量，每项试验使用这两种试验中的一种。在此，我们描述并比较了在这两种试验中获得的nAb滴度。我们观察到，当对世界卫生组织的抗SARS-CoV-2免疫球蛋白国际标准品、新冠康复者血清和mRNA-1273疫苗接种者血清同时进行这两种试验时，其中一种试验始终产生比另一种试验更高的nAb滴度。为了克服这种读数差异在比较/合并来自这两种试验的数据时所带来的挑战，我们评估了三种校准方法，并表明这两种试验的读数可以校准到一个共同的尺度。这些结果可能有助于基于这些试验的数据进行决策，以评估和批准新的或改良的新冠病毒疫苗。
