Preclinical characterization of the Omicron XBB.1.5-adapted BNT162b2 COVID-19 vaccine

Abstract As SARS-CoV-2 evolves, increasing in potential for greater transmissibility and immune escape, updated vaccines are needed to boost adaptive immunity to protect against COVID-19 caused by circulating strains. Here, we report features of the monovalent Omicron XBB.1.5-adapted BNT162b2 vaccin...

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Main Authors: Kayvon Modjarrad, Ye Che, Wei Chen, Huixian Wu, Carla I. Cadima, Alexander Muik, Mohan S. Maddur, Kristin R. Tompkins, Lyndsey T. Martinez, Hui Cai, Minah Ramos, Sonia Mensah, Brittney Cumbia, Larissa Falcao, Andrew P. McKeen, Jeanne S. Chang, Kimberly F. Fennell, Kevin W. Huynh, Thomas J. McLellan, Parag V. Sahasrabudhe, Michael Cerswell, Miguel A. Garcia, Shilong Li, Rahul Sharma, Weiqiang Li, Kristianne P. Dizon, Stacy Duarte, Frank Gillett, Rachel Smith, Deanne M. Illenberger, Kari Sweeney Efferen, Annette B. Vogel, Annaliesa S. Anderson, Uğur Şahin, Kena A. Swanson
Format: Article
Language:English
Published: Nature Portfolio 2024-11-01
Series:npj Vaccines
Online Access:https://doi.org/10.1038/s41541-024-01013-9
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author Kayvon Modjarrad
Ye Che
Wei Chen
Huixian Wu
Carla I. Cadima
Alexander Muik
Mohan S. Maddur
Kristin R. Tompkins
Lyndsey T. Martinez
Hui Cai
Minah Ramos
Sonia Mensah
Brittney Cumbia
Larissa Falcao
Andrew P. McKeen
Jeanne S. Chang
Kimberly F. Fennell
Kevin W. Huynh
Thomas J. McLellan
Parag V. Sahasrabudhe
Wei Chen
Michael Cerswell
Miguel A. Garcia
Shilong Li
Rahul Sharma
Weiqiang Li
Kristianne P. Dizon
Stacy Duarte
Frank Gillett
Rachel Smith
Deanne M. Illenberger
Kari Sweeney Efferen
Annette B. Vogel
Annaliesa S. Anderson
Uğur Şahin
Kena A. Swanson
author_facet Kayvon Modjarrad
Ye Che
Wei Chen
Huixian Wu
Carla I. Cadima
Alexander Muik
Mohan S. Maddur
Kristin R. Tompkins
Lyndsey T. Martinez
Hui Cai
Minah Ramos
Sonia Mensah
Brittney Cumbia
Larissa Falcao
Andrew P. McKeen
Jeanne S. Chang
Kimberly F. Fennell
Kevin W. Huynh
Thomas J. McLellan
Parag V. Sahasrabudhe
Wei Chen
Michael Cerswell
Miguel A. Garcia
Shilong Li
Rahul Sharma
Weiqiang Li
Kristianne P. Dizon
Stacy Duarte
Frank Gillett
Rachel Smith
Deanne M. Illenberger
Kari Sweeney Efferen
Annette B. Vogel
Annaliesa S. Anderson
Uğur Şahin
Kena A. Swanson
author_sort Kayvon Modjarrad
collection DOAJ
description Abstract As SARS-CoV-2 evolves, increasing in potential for greater transmissibility and immune escape, updated vaccines are needed to boost adaptive immunity to protect against COVID-19 caused by circulating strains. Here, we report features of the monovalent Omicron XBB.1.5-adapted BNT162b2 vaccine, which contains XBB.1.5-specific sequence changes, relative to the original BNT162b2 backbone, in the encoded prefusion-stabilized SARS-CoV-2 spike protein (S(P2)). Biophysical characterization of Omicron XBB.1.5 S(P2) demonstrated that it maintains a prefusion conformation and adopts a flexible, predominantly open, state, with high affinity for the human ACE-2 receptor. When administered as a 4th dose in BNT162b2-experienced mice, the monovalent Omicron XBB.1.5 vaccine elicited substantially higher serum neutralizing titers against pseudotyped viruses of Omicron XBB.1.5, XBB.1.16, XBB.1.16.1, XBB.2.3, EG.5.1 and HV.1 sublineages and phylogenetically distant BA.2.86 lineage than the bivalent Wild Type + Omicron BA.4/5 vaccine. Similar trends were observed against Omicron XBB sublineage pseudoviruses when the vaccine was administered as a 2-dose series in naive mice. Strong S-specific Th1 CD4+ and IFNγ+ CD8+ T cell responses were also observed. These findings, together with real world performance of the XBB.1.5-adapted vaccine, suggest that preclinical data for the monovalent Omicron XBB.1.5-adapted BNT162b2 was predictive of protective immunity against dominant SARS-CoV-2 strains.
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spelling doaj-art-1f81685a3cb940afbcebd45045b3eb642025-08-20T02:32:56ZengNature Portfolionpj Vaccines2059-01052024-11-019111310.1038/s41541-024-01013-9Preclinical characterization of the Omicron XBB.1.5-adapted BNT162b2 COVID-19 vaccineKayvon Modjarrad0Ye Che1Wei Chen2Huixian Wu3Carla I. Cadima4Alexander Muik5Mohan S. Maddur6Kristin R. Tompkins7Lyndsey T. Martinez8Hui Cai9Minah Ramos10Sonia Mensah11Brittney Cumbia12Larissa Falcao13Andrew P. McKeen14Jeanne S. Chang15Kimberly F. Fennell16Kevin W. Huynh17Thomas J. McLellan18Parag V. Sahasrabudhe19Wei Chen20Michael Cerswell21Miguel A. Garcia22Shilong Li23Rahul Sharma24Weiqiang Li25Kristianne P. Dizon26Stacy Duarte27Frank Gillett28Rachel Smith29Deanne M. Illenberger30Kari Sweeney Efferen31Annette B. Vogel32Annaliesa S. Anderson33Uğur Şahin34Kena A. Swanson35Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Discovery Sciences, Pfizer Inc.BioNTech SEBioNTech SEVaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Global Biometrics and Data Management, Pfizer Inc.Discovery Sciences, Pfizer Inc.Discovery Sciences, Pfizer Inc.Discovery Sciences, Pfizer Inc.Discovery Sciences, Pfizer Inc.Discovery Sciences, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.Vaccine Research and Development, Pfizer Inc.BioNTech SEVaccine Research and Development, Pfizer Inc.BioNTech SEVaccine Research and Development, Pfizer Inc.Abstract As SARS-CoV-2 evolves, increasing in potential for greater transmissibility and immune escape, updated vaccines are needed to boost adaptive immunity to protect against COVID-19 caused by circulating strains. Here, we report features of the monovalent Omicron XBB.1.5-adapted BNT162b2 vaccine, which contains XBB.1.5-specific sequence changes, relative to the original BNT162b2 backbone, in the encoded prefusion-stabilized SARS-CoV-2 spike protein (S(P2)). Biophysical characterization of Omicron XBB.1.5 S(P2) demonstrated that it maintains a prefusion conformation and adopts a flexible, predominantly open, state, with high affinity for the human ACE-2 receptor. When administered as a 4th dose in BNT162b2-experienced mice, the monovalent Omicron XBB.1.5 vaccine elicited substantially higher serum neutralizing titers against pseudotyped viruses of Omicron XBB.1.5, XBB.1.16, XBB.1.16.1, XBB.2.3, EG.5.1 and HV.1 sublineages and phylogenetically distant BA.2.86 lineage than the bivalent Wild Type + Omicron BA.4/5 vaccine. Similar trends were observed against Omicron XBB sublineage pseudoviruses when the vaccine was administered as a 2-dose series in naive mice. Strong S-specific Th1 CD4+ and IFNγ+ CD8+ T cell responses were also observed. These findings, together with real world performance of the XBB.1.5-adapted vaccine, suggest that preclinical data for the monovalent Omicron XBB.1.5-adapted BNT162b2 was predictive of protective immunity against dominant SARS-CoV-2 strains.https://doi.org/10.1038/s41541-024-01013-9
spellingShingle Kayvon Modjarrad
Ye Che
Wei Chen
Huixian Wu
Carla I. Cadima
Alexander Muik
Mohan S. Maddur
Kristin R. Tompkins
Lyndsey T. Martinez
Hui Cai
Minah Ramos
Sonia Mensah
Brittney Cumbia
Larissa Falcao
Andrew P. McKeen
Jeanne S. Chang
Kimberly F. Fennell
Kevin W. Huynh
Thomas J. McLellan
Parag V. Sahasrabudhe
Wei Chen
Michael Cerswell
Miguel A. Garcia
Shilong Li
Rahul Sharma
Weiqiang Li
Kristianne P. Dizon
Stacy Duarte
Frank Gillett
Rachel Smith
Deanne M. Illenberger
Kari Sweeney Efferen
Annette B. Vogel
Annaliesa S. Anderson
Uğur Şahin
Kena A. Swanson
Preclinical characterization of the Omicron XBB.1.5-adapted BNT162b2 COVID-19 vaccine
npj Vaccines
title Preclinical characterization of the Omicron XBB.1.5-adapted BNT162b2 COVID-19 vaccine
title_full Preclinical characterization of the Omicron XBB.1.5-adapted BNT162b2 COVID-19 vaccine
title_fullStr Preclinical characterization of the Omicron XBB.1.5-adapted BNT162b2 COVID-19 vaccine
title_full_unstemmed Preclinical characterization of the Omicron XBB.1.5-adapted BNT162b2 COVID-19 vaccine
title_short Preclinical characterization of the Omicron XBB.1.5-adapted BNT162b2 COVID-19 vaccine
title_sort preclinical characterization of the omicron xbb 1 5 adapted bnt162b2 covid 19 vaccine
url https://doi.org/10.1038/s41541-024-01013-9
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