在高风险人群中对Mpox进行暴露前预防的LC16m8:一项开放式随机试验
Nobumasa Okumura1, Eriko Morino2,3,4, Hidetoshi Nomoto1
1Disease Control and Prevention Center, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-Ku, Tokyo 162-8655, Japan.
概括
LC16m8疫苗在艾滋病毒感染者中显示出有希望的免疫性和安全性,用于mopox预防. 虽然无法确定疗效,但它表明它适合针对风险人群的向疫苗接种.
科学领域:
- 传染性疾病 传染性疾病
- 疫苗学 疫苗学 疫苗学
- 公共卫生 公共卫生
背景情况:
- 麻疹 (以前称为麻疹) 构成了严重的公共卫生威胁,需要采取有效的预防策略.
- 对于高风险人群,正在研究使用LC16m8等疫苗的暴露前预防 (PrEP).
- 了解疫苗的安全性和免疫性对于广泛采用至关重要.
研究的目的:
- 为了评估LC16m8疫苗在mopox预防方面的有效性.
- 评估LC16m8在高风险人群中的安全性和免疫性,包括艾滋病毒感染者.
- 为了比较早期与晚期的疫苗接种计划.
主要方法:
- 一个多中心的,随机的,开放的标签试验,涉及高风险的成年人mpox.
- 参与者被随机分配,在研究的早期或晚期接受LC16m8疫苗.
- 主要终点:针对mopox的疫苗疗效 (VE);次要终点:严重的mopox,症状,不良事件 (AE) 和免疫性,特别是在感染HIV的参与者中.
主要成果:
- 没有报告mopox病例,因此无法计算初级疗效.
- 观察到高血清转化率:LC16m8 (96.2%的艾滋病毒感染者,92.0%的无艾滋病毒感染者) 和MPXV (69.2%的艾滋病毒感染者,52.0%的无艾滋病毒感染者) 在感染艾滋病毒的参与者中.
- 疫苗的耐受性一般很好,接种率高,严重不良事件发生率低.
结论:
- LC16m8在艾滋病毒控制良好的人群中显示出免疫性和可接受的安全性.
- 这项研究表明,LC16m8可能适合在高危人群中针对性地接种mopox疫苗.
- 需要进一步的研究来证实疫苗在预防mopox感染方面的有效性.
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