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BNT162b vaccines are immunogenic and protect non-human primates against SARS-CoV-2
Annette B. Vogel; Isis Kanevsky; Ye Che; Kena A. Swanson; Alexander Muik; Mathias Vormehr; Lena M. Kranz; Kerstin C. Walzer; Stephanie Hein; Alptekin Gueler; Jakob Loschko; Mohan S. Maddur; Ayuko Ota-Setlik; Kristin Tompkins; Journey Cole; Bonny Gaby Lui; Thomas Ziegenhals; Arianne Plaschke; David Eisel; Sarah C. Dany; Stephanie Fesser; Stephanie Erbar; Ferdia Bates; Diana Schneider; Bernadette Jesionek; Bianca Saenger; Ann-Kathrin Wallisch; Yvonne Feuchter; Hanna Junginger; Stefanie A. Krumm; Andre P. Heinen; Petra Adams-Quack; Julia Schlereth; Stefan Schille; Christoph Kroener; Ramon de la Caridad Gueimil Garcia; Thomas Hiller; Leyla Fischer; Rani S. Sellers; Shambhunath Choudhary; Olga Gonzalez; Fulvia Vascotto; Matthew R. Gutman; Jane Fontenot; Shannan Hall-Ursone; Kathleen Brasky; Matthew C Griffor; Seungil Han; Andreas A.H. Su; Joshua Lees; Nicole L. Nedoma; Ellene H. Mashalidis; Parag V. Sahasrabudhe; Charles Y. Tan; Danka Pavliakova; Guy Singh; Camila Fontes-Garfias; Michael Pride; Ingrid L. Scully; Tara Ciolino; Jennifer Obregon; Michal Gazi; Ricardo Carrion Jr.; Kendra J. Alfson; Warren V. Kalina; Deepak Kaushal; Pei-Yong Shi; Thorsten Klamp; Corinna Rosenbaum; Andreas N. Kuhn; Oezlem Tuereci; Philip R. Dormitzer; Kathrin U. Jansen; Ugur Sahin.
Afiliación
  • Annette B. Vogel; BioNTech Corp.
  • Isis Kanevsky; Pfizer Inc.
  • Ye Che; Pfizer Inc.
  • Kena A. Swanson; Pfizer Inc.
  • Alexander Muik; BioNTech Corp.
  • Mathias Vormehr; BioNTech Corp.
  • Lena M. Kranz; BioNTech Corp.
  • Kerstin C. Walzer; BioNTech Corp.
  • Stephanie Hein; BioNTech Corp.
  • Alptekin Gueler; BioNTech Corp.
  • Jakob Loschko; Pfizer Inc.
  • Mohan S. Maddur; Pfizer Inc.
  • Ayuko Ota-Setlik; Pfizer Inc.
  • Kristin Tompkins; Pfizer inc.
  • Journey Cole; Texas Biomedical Research Institute
  • Bonny Gaby Lui; BioNTech Corp.
  • Thomas Ziegenhals; BioNTech Corp.
  • Arianne Plaschke; BioNTech Corp.
  • David Eisel; BioNTech Corp.
  • Sarah C. Dany; BioNTech Corp.
  • Stephanie Fesser; BioNTech Corp.
  • Stephanie Erbar; BioNTech Corp.
  • Ferdia Bates; BioNTech Corp.
  • Diana Schneider; BioNTech Corp.
  • Bernadette Jesionek; BioNTech Corp.
  • Bianca Saenger; BioNTech Corp.
  • Ann-Kathrin Wallisch; BioNTech Corp.
  • Yvonne Feuchter; BioNTech Corp.
  • Hanna Junginger; BioNTech Corp.
  • Stefanie A. Krumm; BioNTech Corp.
  • Andre P. Heinen; BioNTech Corp.
  • Petra Adams-Quack; BioNTech Corp.
  • Julia Schlereth; BioNTech Corp.
  • Stefan Schille; BioNTech Corp.
  • Christoph Kroener; BioNTech Corp.
  • Ramon de la Caridad Gueimil Garcia; BioNTech Corp.
  • Thomas Hiller; BioNTech Corp.
  • Leyla Fischer; BioNTech Corp.
  • Rani S. Sellers; Pfizer Inc.
  • Shambhunath Choudhary; Pfizer inc.
  • Olga Gonzalez; Texas Biomedical Research Institute
  • Fulvia Vascotto; TRON gGmbH
  • Matthew R. Gutman; VCA SouthPaws Veterinary Specialists and Emergency Center
  • Jane Fontenot; New Iberia Research Center
  • Shannan Hall-Ursone; Texas Biomedical Research Institute
  • Kathleen Brasky; Texas Biomedical Research Institute
  • Matthew C Griffor; Pfizer Inc.
  • Seungil Han; Pfizer Inc
  • Andreas A.H. Su; BioNTech Corp.
  • Joshua Lees; Pfizer inc.
  • Nicole L. Nedoma; Pfizer Inc.
  • Ellene H. Mashalidis; Pfizer inc.
  • Parag V. Sahasrabudhe; Pfizer inc.
  • Charles Y. Tan; Pfizer Inc.
  • Danka Pavliakova; Pfizer Inc.
  • Guy Singh; Pfizer Inc.
  • Camila Fontes-Garfias; University of Texas Medical Branch
  • Michael Pride; Pfizer Inc.
  • Ingrid L. Scully; Pfizer Inc.
  • Tara Ciolino; Pfizer Inc.
  • Jennifer Obregon; Pfizer Inc.
  • Michal Gazi; Texas Biomedical Research Institute
  • Ricardo Carrion Jr.; Texas Biomedical Research Institute
  • Kendra J. Alfson; Texas Biomedical Research Institute
  • Warren V. Kalina; Pfizer Inc.
  • Deepak Kaushal; Texas Biomedical Research Institute
  • Pei-Yong Shi; University of Texas Medical Branch
  • Thorsten Klamp; BioNTech Corp.
  • Corinna Rosenbaum; BioNTech Corp.
  • Andreas N. Kuhn; BioNTech Corp.
  • Oezlem Tuereci; BioNTech Corp.
  • Philip R. Dormitzer; Pfizer Inc.
  • Kathrin U. Jansen; Pfizer Inc.
  • Ugur Sahin; BioNTech Corp.
Preprint en En | PREPRINT-BIORXIV | ID: ppbiorxiv-421008
ABSTRACT
A safe and effective vaccine against COVID-19 is urgently needed in quantities sufficient to immunise large populations. We report the preclinical development of two BNT162b vaccine candidates, which contain lipid-nanoparticle (LNP) formulated nucleoside-modified mRNA encoding SARS-CoV-2 spike glycoprotein-derived immunogens. BNT162b1 encodes a soluble, secreted, trimerised receptor-binding domain (RBD-foldon). BNT162b2 encodes the full-length transmembrane spike glycoprotein, locked in its prefusion conformation (P2 S). The flexibly tethered RBDs of the RBD-foldon bind ACE2 with high avidity. Approximately 20% of the P 2S trimers are in the two-RBD down, one-RBD up state. In mice, one intramuscular dose of either candidate elicits a dose-dependent antibody response with high virus-entry inhibition titres and strong TH1 CD4+ and IFN{gamma}+ CD8+ T-cell responses. Prime/boost vaccination of rhesus macaques with BNT162b candidates elicits SARS-CoV-2 neutralising geometric mean titres 8.2 to 18.2 times that of a SARS-CoV-2 convalescent human serum panel. The vaccine candidates protect macaques from SARS-CoV-2 challenge, with BNT162b2 protecting the lower respiratory tract from the presence of viral RNA and with no evidence of disease enhancement. Both candidates are being evaluated in phase 1 trials in Germany and the United States. BNT162b2 is being evaluated in an ongoing global, pivotal Phase 2/3 trial (NCT04380701, NCT04368728).
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Texto completo: 1 Colección: 09-preprints Base de datos: PREPRINT-BIORXIV Tipo de estudio: Experimental_studies / Rct Idioma: En Año: 2020 Tipo del documento: Preprint
Texto completo
Añadir a Mi BVS
Imprimir
XML
Buscar en Google
Texto completo: 1 Colección: 09-preprints Base de datos: PREPRINT-BIORXIV Tipo de estudio: Experimental_studies / Rct Idioma: En Año: 2020 Tipo del documento: Preprint