检查疫苗接种或单克隆抗体管理后SARS-CoV-2中和抗体的保护作用
Dean Follmann1, Meagan P O'Brien2, Jonathan Fintzi3
1Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. dfollmann@niaid.nih.gov.
Nature communications
|June 17, 2023
概括
中和抗体标位与SARS-CoV-2疫苗和单克隆抗体治疗的保护相关. 这项研究支持使用抗体标位作为替代终点来授权新的单克隆抗体疗法.
科学领域:
- 免疫学 免疫学 免疫学
- 传染性疾病 传染性疾病
- 疫苗学 疫苗学 疫苗学
背景情况:
- 目前的SARS-CoV-2疫苗是根据对变种的中和抗体 (nAb) 标位授权的.
- 预防性单克隆抗体 (mAbs) 缺乏类似的授权途径.
- 评估nAb标位作为保护的相关值对于疫苗和mAbs都至关重要.
研究的目的:
- 评估nAb标位作为COVID-19预防保护的相关值.
- 将单克隆抗体治疗中的nAb标位与mRNA-1273疫苗中的nAb标位进行比较.
- 为了确定nAb标位作为一个潜在的替代终点mAb授权.
主要方法:
- 从casirivimab + imdevimab mAb预防试验 (NCT04452318) 的nAb标位的分析.
- 从mRNA-1273疫苗试验 (NCT04470427) 中评估nAb标位.
- 在两种试验设置中,nAb标位与保护功效的相关性.
主要成果:
- 在mAb试验中,92%的保护疗效与1000 IU50/ml的nAb标位有关.
- 在疫苗试验中,93%和97%的保护疗效与分别为100和1000 IU50/ml的nAb标位有关.
- 数据量 nAb 位与 mAbs 的保护相关,与疫苗诱导的 nAb 位进行基准测试.
结论:
- 中和抗体标位是COVID-19疫苗和单克隆抗体的相关保护.
- 这些发现支持使用nAb标位作为替代终点来授权新的预防性单克隆抗体.
- 建立标准化的nAb标位相关值可以简化未来COVID-19对策的批准过程.
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