一个随机的,开放的标签研究尼波卡利马布对健康参与者的疫苗反应的影响
Marta Cossu1, Carolina Bobadilla Mendez2, Amanda Jackson3
1Johnson & Johnson, Leiden, The Netherlands.
Human vaccines & immunotherapeutics
|April 15, 2025
概括
尼波卡利马布是一种IgG1单克隆抗体,在健康成年人中没有显著影响疫苗反应. 这项研究表明,尼波卡利马布可以安全地与常规疫苗接种一起使用,支持其在推的免疫接种计划中使用.
科学领域:
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
- 疫苗学 疫苗学 疫苗学
背景情况:
- 尼波卡利马布是一种针对新生儿Fc受体 (FcRn) 的IgG1单克隆抗体.
- 它通过抑制IgG回收来降低免疫球蛋白G (IgG) 水平.
- 尼波卡利马布对疫苗诱导的IgG反应的影响需要评估.
研究的目的:
- 评估尼波卡利马布对对T细胞依赖和T细胞独立疫苗的IgG反应的影响.
- 评估尼波卡利马布与疫苗同时使用时的安全性和耐受性.
- 为了确定尼波卡利马布是否会影响达到保护性抗体水平的能力.
主要方法:
- 第1期,健康成年人的开放标签研究.
- 参与者接受了尼波卡利马布 (30毫克/公斤第0周;15毫克/公斤第2,4周) 或没有药物 (对照).
- 接种的疫苗包括毒素,白喉和非细胞性百日咳 (Tdap) 和23肺炎球菌多糖体疫苗 (PPSV®23).
主要成果:
- 所有参与者都对Tdap产生了反应;在第4周的尼波卡利马布手臂中,毒素 (TT) 反应率在数值上较低 (20%vs50%).
- 尼波卡利马布在第4周与数值较低的抗TT和抗肺炎球菌 (PCP) IgG反应有关,但在第2周和第16周的反应相似.
- 所有参与者都保持了两种疫苗的IgG水平高于保护值;尼波卡利马布的同时使用是安全的,并且耐受良好.
结论:
- 尼波卡利马布不会显著影响IgG对常见疫苗的反应的发展.
- 接受尼波卡利马布的参与者可以遵守推的疫苗接种计划.
- 安全性概况支持将尼波卡利马布与Tdap和PPSV®23疫苗同时使用.
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