双价和单价SARS-CoV-2变种疫苗的比较:第二阶段随机开放标签COVAIL试验
Angela R Branche1, Nadine G Rouphael2, David J Diemert3
1Department of Medicine, Division of Infectious Diseases, University of Rochester, Rochester, NY, USA. angela_branche@urmc.rochester.edu.
Nature medicine
|August 28, 2023
概括
针对Beta或Omicron BA.1的更新的COVID-19疫苗提供了针对SARS-CoV-2变种的广泛保护. 这些增强剂提供交叉保护性中和抗体,而不会失去对原始菌株的免疫力.
科学领域:
- 免疫学 免疫学 免疫学
- 病毒学 病毒学
- 疫苗学 疫苗学 疫苗学
背景情况:
- 针对严重急性呼吸系统综合征冠状病毒2 (SARS-CoV-2) 的疫苗免疫力下降,需要更新的增强剂策略.
- 对新出现的SARS-CoV-2变种进行新型单价和双价疫苗的评估至关重要.
研究的目的:
- 通过使用变种特定的SARS-CoV-2疫苗来评估第二次增剂剂量的安全性和免疫性.
- 为了比较单价和双价疫苗对各种SARS-CoV-2菌株产生的中和抗体反应.
主要方法:
- 第二阶段,开放标签,随机临床试验遍及22个美国地点.
- 测序注册评估mRNA和基于蛋白质的平台与野生类型,Beta,Delta和Omicron BA.1尖峰抗原.
- 主要结果:伪病毒中和标位 (ID50);次要结果:对不良事件的安全监测.
主要成果:
- 含有变异的疫苗在所有变异的中和标位上数量上优于原型/野生型疫苗.
- 单价欧米克朗BA.1或Beta疫苗的中和效果与针对Beta,欧米克朗BA.1和欧米克朗BA.4/5.5的双价疫苗的中和效果相当.
- 与同时代的Omicron亚型病毒相对的中和性在与单价疫苗相比较,与双价疫苗相比较低.
- 在缺乏原型菌株的变种疫苗中,没有观察到对D614G的中和性减少.
- 所有疫苗臂的不良事件概况都相似,与之前的报道相比.
结论:
- 针对Beta或Omicron BA.1的最新疫苗引发了广泛的交叉保护性中和抗体反应.
- 这些变种特异性增强剂不会损害对祖先SARS-CoV-2菌株的免疫力.
- 该研究支持使用更新的疫苗,以持续保护各种SARS-CoV-2变种.
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