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<p>We preclinically characterize BNT162b3, a nucleoside-modified mRNA-based coronavirus disease 2019 (COVID-19) vaccine encoding a trimerized, cell surface-tethered severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike receptor-binding domain (RBD-foldon), formulated in lipid nanoparticles. Intramuscular immunization with BNT162b3 induced high antigen-specific antibody titers with early seroconversion kinetics in mice and rhesus macaques. One dose of BNT162b3 induced high neutralizing antibody titers against pseudoviruses harboring the spike of the SARS-CoV-2 Wuhan-Hu-1 strain and early variants of concern up to Delta, but lower titers against Omicron, the phylogenetically more distant variant. In mice, a second immunization boosted Omicron neutralizing antibody titers to levels comparable to those of other tested variants. The cellular immune response was T helper 1 cell driven. The cell surface-tethered RBD-foldon was more immunogenic than its soluble counterpart. This study demonstrated the suitability of BNT162b3 as COVID-19 vaccine and supported its evaluation in a phase I/II clinical trial (BNT162-04, NCT04537949).</p>

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Strong and early immune responses against SARS-CoV-2 in mice and rhesus macaques after BNT162b3 vaccination

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月13日

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  • Annette B. Vogel,
  • Bonny G. Lui,
  • Kristin Tompkins,
  • Isis Kanevsky,
  • Alexander Muik,
  • Stefanie A. Krumm,
  • Alptekin Güler,
  • Mohan S. Maddur,
  • Kerstin C. Walzer,
  • Sonja Witzel,
  • Fulvia Vascotto,
  • Eliana Stanganello,
  • Ayuko Ota-Setlik,
  • Kimberly J. Cottingham,
  • Omaira Allbritton,
  • Jessica Keverne,
  • Letícia Aragão-Santiago,
  • Kena A. Swanson,
  • Özlem Türeci,
  • Uğur Şahin

摘要

We preclinically characterize BNT162b3, a nucleoside-modified mRNA-based coronavirus disease 2019 (COVID-19) vaccine encoding a trimerized, cell surface-tethered severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike receptor-binding domain (RBD-foldon), formulated in lipid nanoparticles. Intramuscular immunization with BNT162b3 induced high antigen-specific antibody titers with early seroconversion kinetics in mice and rhesus macaques. One dose of BNT162b3 induced high neutralizing antibody titers against pseudoviruses harboring the spike of the SARS-CoV-2 Wuhan-Hu-1 strain and early variants of concern up to Delta, but lower titers against Omicron, the phylogenetically more distant variant. In mice, a second immunization boosted Omicron neutralizing antibody titers to levels comparable to those of other tested variants. The cellular immune response was T helper 1 cell driven. The cell surface-tethered RBD-foldon was more immunogenic than its soluble counterpart. This study demonstrated the suitability of BNT162b3 as COVID-19 vaccine and supported its evaluation in a phase I/II clinical trial (BNT162-04, NCT04537949).