BA.1 和 BA.4/BA.5 二价 SARS-CoV-2 加强免疫的免疫原性：COVAIL 随机临床试验的初步结果。
Immunogenicity of the BA.1 and BA.4/BA.5 Severe Acute Respiratory Syndrome Coronavirus 2 Bivalent Boosts: Preliminary Results From the COVAIL Randomized Clinical Trial.
机构信息
Department of Medicine, University of Rochester VTEU, Rochester, New York, USA.
Department of Medicine, Emory University Hope Clinic, Decatur, Georgia, USA.
出版信息
Clin Infect Dis. 2023 Aug 22;77(4):560-564. doi: 10.1093/cid/ciad209.
Abstract
In a randomized clinical trial, we compare early neutralizing antibody responses after boosting with bivalent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccines based on either BA.1 or BA.4/BA.5 Omicron spike protein combined with wild-type spike. Responses against SARS-CoV-2 variants exhibited the greatest reduction in titers against currently circulating Omicron subvariants for both bivalent vaccines.
摘要
在一项随机临床试验中，我们比较了基于 BA.1 或 BA.4/BA.5 奥密克戎刺突蛋白与野生型刺突蛋白的二价严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）信使 RNA（mRNA）疫苗加强后产生的早期中和抗体反应。两种二价疫苗对 SARS-CoV-2 变体的反应均显示出针对当前流行的奥密克戎亚变体滴度的最大降低。
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2
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3
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4
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