针对 COVID-19 疫苗的基于人群的保护阈值。
Towards a population-based threshold of protection for COVID-19 vaccines.
机构信息
Great Ormond Street Institute of Child Health, University College London, 30 Guilford Street, London WC1N 1 EH, UK; Great Ormond Street Children's Hospital NHS Foundation Trust, Great Ormond Street, London WC1N 3JH, UK.
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
出版信息
Vaccine. 2022 Jan 21;40(2):306-315. doi: 10.1016/j.vaccine.2021.12.006. Epub 2021 Dec 15.
Correlates of protection for COVID-19 vaccines are urgently needed to license additional vaccines. We measured immune responses to four COVID-19 vaccines of proven efficacy using a single serological platform. IgG anti-Spike antibodies were highly correlated with ID50 neutralization in a validated pseudoviral assay and correlated significantly with efficacies for protection against infection with wild-type, alpha and delta variant SARS-CoV-2 virus. The protective threshold for each vaccine was calculated for IgG anti-Spike antibody. The mean protective threshold for all vaccine studies for WT virus was 154 BAU/ml (95 %CI 42-559), and for studies with antibody distributions that enabled precise estimation of thresholds (i.e. leaving out 2-dose mRNA regimens) was 60 BAU/ml (95 %CI 35-102). We propose that the proportion of individuals with responses above the appropriate protective threshold together with the geometric mean concentration can be used in comparative non-inferiority studies with licensed vaccines to ensure that new vaccines will be efficacious.
我们使用单一的血清学平台，对四种已被证实具有疗效的 COVID-19 疫苗的免疫反应进行了测量。IgG 抗刺突抗体与经验证的假病毒中和测定中的 ID50 高度相关，与预防野生型、阿尔法和德尔塔变异 SARS-CoV-2 病毒感染的功效显著相关。我们为每种疫苗的 IgG 抗刺突抗体计算了保护阈值。所有针对 WT 病毒的疫苗研究的平均保护阈值为 154 BAU/ml（95%CI 42-559），对于能够精确估计阈值的抗体分布研究（即排除 2 剂 mRNA 方案）为 60 BAU/ml（95%CI 35-102）。我们提出，具有适当保护阈值以上反应的个体比例以及几何均数浓度可以用于与已许可疫苗的比较非劣效性研究，以确保新疫苗将是有效的。
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