人类挑战试验核酸修饰的信使核酸核酸流感疫苗
Kelly A Lindert1, Alex Mann2, Anita Geevarughese3
1Vaccine Research & Development, Pfizer, Cambridge, MA, USA.
NEJM evidence
|November 19, 2025
概括
核酸修饰的信使RNA (modRNA) 流感疫苗在人类挑战试验中显示出100%的疫苗有效性,对抗症状和发烧性流感. 与对照组相比,modRNA疫苗也减少了病毒载量.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 传染性疾病 传染性疾病
- 分子生物学分子生物学
背景情况:
- 人类挑战试验对于评估流感疫苗有效性至关重要.
- 核酸改性信使RNA (modRNA) 流感疫苗代表了流感免疫的新平台.
- 对于 modRNA 流感疫苗,没有先前报告的人类挑战试验.
研究的目的:
- 在人类挑战试验中评估 modRNA 流感疫苗的疗效和安全性.
- 将modRNA疫苗的性能与四价流感疫苗 (QIV) 和对照组进行比较.
- 评估病毒载量减少作为一个关键的疗效终点.
主要方法:
- 进行了一项2a期,双盲,随机对照试验.
- 18-55岁的健康成年人在流感A/H1N1挑战前30天接受了modRNA或QIV疫苗.
- 用症状和发烧性流感率,曲线下的病毒载荷面积 (VL-AUC) 和峰值病毒载荷 (VL) 来衡量有效性.
主要成果:
- modRNA 疫苗组显示 0% 的症状性流感和 0% 的发烧性流感,在两个终点上实现了 100% 的疫苗疗效 (VE).
- 四价流感疫苗 (QIV) 组有4.2%的症状和0%的发烧性流感,VE分别为84.5%和100.0%.
- 与对照组相比,modRNA疫苗显示VL-AUC和峰值VL的显著降低,没有报告严重不良事件.
结论:
- 在人类挑战模型中,modRNA流感疫苗在对照组相比表现出更高的疗效.
- modRNA 疫苗耐受性很好,没有观察到严重的不良事件.
- 这些发现支持modRNA技术在开发有效流感疫苗方面的潜力.
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