疫苗诱导的严重急性呼吸综合征冠状病毒2抗体反应及加速开发之路（确定保护的相关因素）
Vaccine-Induced Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Response and the Path to Accelerating Development (Determining a Correlate of Protection).
作者信息
Sherman Amy C, Desjardins Michaël, Baden Lindsey R
机构信息
Division of Infectious Diseases, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA; Harvard Medical School, Boston, MA 02115, USA.
Division of Infectious Diseases, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA; Harvard Medical School, Boston, MA 02115, USA; Division of Infectious Diseases, Centre Hospitalier de l'Université de Montréal, 1000 Rue Saint-Denis, Bureau F06.1102b, Montreal, Quebec H2X 0C1, Canada.
出版信息
Clin Lab Med. 2022 Mar;42(1):111-128. doi: 10.1016/j.cll.2021.10.008. Epub 2021 Nov 3.
Abstract
As new public health challenges relating to COVID-19 emerge, such as variant strains, waning vaccine efficacy over time, and decreased vaccine efficacy for special populations (immunocompromised hosts), it is important to determine a correlate of protection (CoP) to allow accurate bridging studies for special populations and against variants of concern. Large-scale phase 3 clinical trials are inefficient to rapidly assess novel vaccine candidates for variant strains or special populations, because these trials are slow and costly. Defining a practical CoP will aid in efficiently conducting future assessments to further describe protection for individuals and on a population level for surveillance.
摘要
随着与新冠病毒相关的新的公共卫生挑战不断出现，如变异毒株、疫苗效力随时间减弱以及特殊人群（免疫功能低下宿主）的疫苗效力降低，确定一个保护相关指标（CoP）对于针对特殊人群和关注变异株进行准确的桥接研究至关重要。大规模3期临床试验对于快速评估针对变异株或特殊人群的新型候选疫苗效率低下，因为这些试验耗时且成本高昂。定义一个实用的CoP将有助于高效地开展未来评估，以进一步描述个体层面和人群层面的监测保护情况。
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