成年人Ad26.COV2.S的安全性和免疫性:一个随机,双盲,安慰剂控制的2a期剂量确定研究
Vicky Cárdenas1, Mathieu Le Gars2, Carla Truyers3
1Janssen Research & Development LLC, Spring House, PA, United States.
Vaccine
|May 5, 2024
概括
一次剂量的Ad26.COV2.S疫苗对预防COVID-19有效. 增剂剂量和更长的间隔增强了免疫反应,支持主要的单剂量计划与6个月的增剂.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 免疫学 免疫学 免疫学
- 病毒学 病毒学
背景情况:
- Ad26.COV2.S (詹森COVID-19疫苗) 提供对中度至重度COVID-19的保护.
- 了解最佳剂量策略对于疫苗有效性至关重要.
研究的目的:
- 评估剂量水平,剂量数和间隔对Ad26.COV2.S免疫性,反应性和安全性的影响.
- 为了探索对Ad26.COV2.S.的历史回应.
主要方法:
- 2a期,随机,双盲,成年人 (18-55岁和≥65岁) 的安慰剂对照研究.
- 评估了四个Ad26.COV2.S剂量水平 (1.25x10^10到1x10^11病毒颗粒[vp]),单剂/双剂时间表和56/84天间隔.
- 测量了幽默和细胞介导免疫力,反应性和安全性;评估了疫苗接种后的历史反应.
主要成果:
- 所有Ad26.COV2.S计划都诱导了剂量依赖的幽默反应.
- 一次5x10^10 vp剂量引起了至少6个月的持久抗体和细胞免疫力.
- 两剂方案显示抗体反应比单剂更高,在更长的间隔 (84 vs. 56天) 时大小增加.
- 抗原暴露后的快速,明显的免疫反应表明了免疫记忆;T细胞反应在治疗方案中一致.
- 反应性通常与剂量相关.
结论:
- 支持Ad26.COV2.S初级单剂量计划 (5x10^10 vp) 与6个月后同类增强剂.
- 一次和两次剂量初级疫苗接种有效诱导免疫记忆,其证据是对抗原暴露的快速反应.
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