在12岁以上的儿童中使用双对应的Omicron-BA.4/BA.5-Adapted BNT162b2助推器
Lisa Usdan1, Sohil Patel2, Hector Rodriguez3
1CNS Healthcare, Memphis, Tennessee, USA.
概括
与原始疫苗相比,双价欧米克朗BA.4/BA.5-适应疫苗 (BNT162b2-Omi.BA.4/BA.5) 在老年人中显示出优越的免疫性. 这种新的强剂疫苗对先前接种疫苗的人来说具有有利的益处风险概况.
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:
- 当代严重急性呼吸系统综合征冠状病毒2 (SARS-CoV-2) 变种需要开发序列适应的疫苗以提供有效的保护.
- 参与本试验的参与者必须先前接种了原始BNT162b2疫苗的30μg剂量的疫苗.
研究的目的:
- 评估不同年龄组的双价欧米克朗BA.4/BA.5-适应BNT162b2疫苗 (BNT162b2-Omi.BA.4/BA.5) 作为第四剂量 (第二增剂) 的免疫性和安全性.
- 在55岁以上的个体中,比较双价疫苗与原始BNT162b2疫苗的免疫反应.
- 在18-55岁的人群中,与55岁以上的人群相比,评估双价疫苗免疫反应的非劣质性.
主要方法:
- 一个涉及12-17,18-55岁和>55岁的2/3期试验,他们接受了30μg剂量的BNT162b2-Omi.BA.4/BA.5作为第二次增强剂.
- 在接种疫苗后一个月,通过测量50%的中和标位和血清反应率来评估免疫学优势和非劣势.
- 与最初的BNT162b2疫苗进行了比较,在一个单独的第三阶段试验队列中.
主要成果:
- 在55岁以上的个体中,BNT162b2-Omi.BA.4/BA.5与原始BNT162b2疫苗相比,表现出优异的Omicron BA.4/BA.5中和标位 (GMR 2.91) 和非劣势的血清反应率.
- 对于BNT162b2-Omi.BA.4/BA.5在18-55岁的人群中,与55岁以上的人群相比,中和标位和血清反应率的非劣质性得到证实.
- 在接种疫苗后的12-17岁儿童中,几何平均标位增加,BNT162b2-Omi.BA.4/BA.5的安全性概况与之前的强化学剂量相当.
结论:
- 30μg的BNT162b2-Omi.BA.4/BA.5强剂疫苗在接种疫苗后长达一个月的免疫性和安全性数据上显示出有利的益处风险概况.
- 这项研究支持使用顺序适应的疫苗,如BNT162b2-Omi.BA.4/BA.5,以加强对当前SARS-CoV-2变种的保护.
- 双价疫苗为需要第二剂补充剂的个人提供了可行的选择,以保持对不断演变的病毒菌株的免疫力.
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