Vaccine Development & Surveillance, Bill & Melinda Gates Foundation, 500 5th Ave N, Seattle, WA 98109, USA.
Independent Advisor, Stuart, FL, USA.
Vaccine. 2021 Jul 22;39(32):4423-4428. doi: 10.1016/j.vaccine.2021.05.063. Epub 2021 May 24.
A correlate of protection (CoP) is urgently needed to expedite development of additional COVID-19 vaccines to meet unprecedented global demand. To assess whether antibody titers may reasonably predict efficacy and serve as the basis of a CoP, we evaluated the relationship between efficacy and in vitro neutralizing and binding antibodies of 7 vaccines for which sufficient data have been generated. Once calibrated to titers of human convalescent sera reported in each study, a robust correlation was seen between neutralizing titer and efficacy (ρ = 0.79) and binding antibody titer and efficacy (ρ = 0.93), despite geographically diverse study populations subject to different forces of infection and circulating variants, and use of different endpoints, assays, convalescent sera panels and manufacturing platforms. Together with evidence from natural history studies and animal models, these results support the use of post-immunization antibody titers as the basis for establishing a correlate of protection for COVID-19 vaccines.
需要一个保护相关指标(CoP)来加速开发额外的 COVID-19 疫苗,以满足前所未有的全球需求。为了评估抗体滴度是否可以合理地预测疗效并作为 CoP 的基础,我们评估了对 7 种疫苗的疗效与体外中和和结合抗体之间的关系,这些疫苗已经产生了足够的数据。在与每个研究报告的人类恢复期血清滴度校准后,中和滴度与疗效之间存在很强的相关性(ρ=0.79),结合抗体滴度与疗效之间也存在很强的相关性(ρ=0.93),尽管研究人群具有地理差异,受到不同感染力度和循环变异的影响,以及使用不同的终点、检测、恢复期血清面板和制造平台。结合自然史研究和动物模型的证据,这些结果支持使用免疫后抗体滴度作为 COVID-19 疫苗保护相关指标的基础。
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