双等效RSVpreF疫苗在18岁至60岁以下的成年人中,具有高风险的疾病
Matthew Davis1, William Towner2, Elliot DeHaan3
1Rochester Clinical Research, Inc., Rochester, New York, USA.
概括
在18-59岁的成年人中,RSVpreF疫苗是安全有效的,对于患有严重呼吸道同胞病毒 (RSV) 疾病的高风险的人来说. 免疫性数据支持其使用,弥合了老年人已证明的疗效.
科学领域:
- 免疫学 免疫学 免疫学
- 疫苗学 疫苗学 疫苗学
- 公共卫生 公共卫生
背景情况:
- 年长的成年人和免疫受损的个体面临严重呼吸道同胞病毒 (RSV) 疾病的更高风险.
- RSVpreF是一种针对RSV预防的候选疫苗.
研究的目的:
- 评估RSVpreF疫苗在18-59岁的成年人中具有严重RSV疾病高风险的安全性和免疫性.
- 在老年人中建立免疫桥梁以先前证明的疗效.
主要方法:
- 一项涉及678名参与者 (18-59岁) 的3期随机试验,分别以2:1分配RSVpreF或安慰剂.
- 主要安全终点包括反应性,不良事件 (AE),严重的AE (SAE) 和新诊断的慢性疾病 (NDCMC).
- 免疫原性在接种疫苗后一个月被评估,并与先前试验 (RENOIR) 中的一组老年人进行了比较.
主要成果:
- 接种RSVpreF疫苗的耐受性很好,大多数不良事件是轻度至中度的.
- 在RSVpreF和安慰剂组之间,AE频率与RSVpreF和安慰剂组相似 (7.1%和7.6%).
- 没有报告疫苗相关的SAE或NDCMCs,并且满足了RSV-A和RSV-B的中和标位和血清反应率的非劣质性标准.
结论:
- 在18-59岁高风险成年人中,RSVpreF表现出了有利的安全概况.
- 该疫苗实现了免疫桥梁,达到先前在老年人中建立的疗效终点.
- 研究结果支持使用RSVpreF预防RSV相关疾病在这个风险人群.
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