使用腺病毒载体和mRNACOVID-19疫苗 (Com-COV) 进行异质与同质原始增强计划的安全性和免疫性:单盲,随机,非劣势试验
Xinxue Liu1, Robert H Shaw2, Arabella S V Stuart2
1Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Lancet (London, England)
|August 9, 2021
概括
使用AstraZeneca (ChAd) 和Pfizer-BioNTech (BNT) 疫苗进行异质性COVID-19疫苗接种显示出有前景. 虽然ChAd/BNT达到非劣势,但BNT/ChAd没有,尽管两者都诱导了比单独ChAd/ChAd更高的抗体水平.
科学领域:
- 免疫学
- 疫苗学
- 传染性疾病
背景情况:
- 不同原始增强COVID-19疫苗计划,结合腺病毒载体 (ChAdOx1 nCoV-19) 和mRNA (BNT162b2) 疫苗,可能有助于大规模免疫工作.
- 之前的研究结果表明,与4周间隔的同源表相比,异构的ChAd/ BNT表具有更高的反应性.
研究的目的:
- 评估使用ChAd和BNT疫苗的异质增强疫苗接种计划的安全性和免疫性.
- 将ChAd/BNT和BNT/ChAd方案的免疫反应和安全概况与同类的ChAd/ChAd和BNT/BNT方案进行比较.
主要方法:
- 一个参与者盲目的,随机的,非劣势性试验 (Com-COV) 招募了50岁以上的未曾感染过SARS-CoV-2的成年人.
- 参与者接受了同源或异源表 (ChAd/ChAd,ChAd/BNT,BNT/BNT,BNT/ChAd) 与28天或84天的初级增强间隔.
- 主要终点: 28天后抗峰IgG的几何平均比率 (GMR),比较异质和同质表.
主要成果:
- 在抗高峰IgG度 (GMR 9.2) 方面,ChAd/ BNT方案显示不低于ChAd/ ChAd.
- 与BNT/BNT (GMR0.51) 相比,BNT/ChAd计划没有满足非劣质标准.
- 两种异种方案都诱导了SARS-CoV-2抗高峰IgG水平高于ChAd/ChAd方案;没有严重的不良事件与疫苗有关.
结论:
- 与ChAd/ChAd相比,Chad/BNT异质原始增强方案是一个可行的选择,显示非劣势性和增强的免疫性.
- 虽然BNT/ChAd没有达到非劣质性,但其抗体反应仍然高于ChAd/ChAd,这表明疫苗使用的潜在灵活性.
- 这些发现支持使用Chad和BNTCOVID-19疫苗的异质增强疫苗接种策略的可能性.
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