PMID- 33139139 OWN - NLM STAT- MEDLINE DCOM- 20201211 LR - 20240330 IS - 1873-2518 (Electronic) IS - 0264-410X (Print) IS - 0264-410X (Linking) VI - 38 IP - 50 DP - 2020 Nov 25 TI - NVX-CoV2373 vaccine protects cynomolgus macaque upper and lower airways against SARS-CoV-2 challenge. PG - 7892-7896 LID - S0264-410X(20)31373-6 [pii] LID - 10.1016/j.vaccine.2020.10.064 [doi] AB - There is an urgent need for a safe and protective vaccine to control the global spread of SARS-CoV-2 and prevent COVID-19. Here, we report the immunogenicity and protective efficacy of a SARS-CoV-2 subunit vaccine (NVX-CoV2373) produced from the full-length SARS-CoV-2 spike (S) glycoprotein stabilized in the prefusion conformation. Cynomolgus macaques (Macaca fascicularis) immunized with NVX-CoV2373 and the saponin-based Matrix-M adjuvant induced anti-S antibody that was neutralizing and blocked binding to the human angiotensin-converting enzyme 2 (hACE2) receptor. Following intranasal and intratracheal challenge with SARS-CoV-2, immunized macaques were protected against upper and lower infection and pulmonary disease. These results support ongoing phase 1/2 clinical studies of the safety and immunogenicity of NVX-CoV2327 vaccine (NCT04368988). CI - Copyright (c) 2020 The Authors. Published by Elsevier Ltd.. All rights reserved. FAU - Guebre-Xabier, Mimi AU - Guebre-Xabier M AD - Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: mguebre-xabier@Novavax.com. FAU - Patel, Nita AU - Patel N AD - Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: npatel@novavax.com. FAU - Tian, Jing-Hui AU - Tian JH AD - Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: jhtian@Novavax.com. FAU - Zhou, Bin AU - Zhou B AD - Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: bzhou@Novavax.com. FAU - Maciejewski, Sonia AU - Maciejewski S AD - Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: smaciejewski@Novavavax.com. FAU - Lam, Kristal AU - Lam K AD - Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: klam@Novavax.com. FAU - Portnoff, Alyse D AU - Portnoff AD AD - Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: aportnoff@Novavax.com. FAU - Massare, Michael J AU - Massare MJ AD - Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: mmassare@Novavax.com. FAU - Frieman, Matthew B AU - Frieman MB AD - University of Maryland, School of Medicine, 685 West Baltimore St, Baltimore, MD 21201, USA. Electronic address: mfrieman@som.umaryland.edu. FAU - Piedra, Pedro A AU - Piedra PA AD - Department of Molecular Virology and Microbiology, and Pediatrics, Baylor College of Medicine, Houston, TX, USA. Electronic address: ppiedra@bcm.edu. FAU - Ellingsworth, Larry AU - Ellingsworth L AD - Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: lellingsworth@novavax.com. FAU - Glenn, Gregory AU - Glenn G AD - Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: gglenn@Novavax.com. FAU - Smith, Gale AU - Smith G AD - Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: gsmith@Novavax.com. LA - eng SI - ClinicalTrials.gov/NCT04368988 PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20201023 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Adjuvants, Immunologic) RN - 0 (Antibodies, Neutralizing) RN - 0 (COVID-19 Vaccines) RN - 0 (Immune Sera) RN - 0 (Spike Glycoprotein, Coronavirus) RN - 0 (Vaccines, Synthetic) RN - 0 (spike protein, SARS-CoV-2) RN - 2SCD8Q63PF (NVX-CoV2373 adjuvated lipid nanoparticle) RN - EC 3.4.17.23 (ACE2 protein, human) RN - EC 3.4.17.23 (Angiotensin-Converting Enzyme 2) SB - IM MH - Adjuvants, Immunologic/pharmacology MH - Adolescent MH - Adult MH - Aged MH - Angiotensin-Converting Enzyme 2/immunology/metabolism MH - Animals MH - Antibodies, Neutralizing MH - COVID-19/immunology/*prevention & control MH - COVID-19 Vaccines/genetics/immunology/*pharmacology MH - Chlorocebus aethiops MH - Female MH - Humans MH - Immune Sera/drug effects/immunology MH - Macaca fascicularis MH - Male MH - Middle Aged MH - SARS-CoV-2/*immunology MH - Spike Glycoprotein, Coronavirus/genetics MH - Vaccines, Synthetic/immunology/pharmacology MH - Vero Cells MH - Viral Load MH - Young Adult PMC - PMC7584426 OTO - NOTNLM OT - COVID-19 OT - Matrix-M adjuvant OT - NVX-CoV2373 nanoparticles OT - Nonhuman primate OT - SARS-CoV-2 OT - Spike glycoprotein COIS- Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2020/11/04 06:00 MHDA- 2020/12/15 06:00 PMCR- 2020/10/23 CRDT- 2020/11/03 05:36 PHST- 2020/08/19 00:00 [received] PHST- 2020/10/02 00:00 [revised] PHST- 2020/10/19 00:00 [accepted] PHST- 2020/11/04 06:00 [pubmed] PHST- 2020/12/15 06:00 [medline] PHST- 2020/11/03 05:36 [entrez] PHST- 2020/10/23 00:00 [pmc-release] AID - S0264-410X(20)31373-6 [pii] AID - 10.1016/j.vaccine.2020.10.064 [doi] PST - ppublish SO - Vaccine. 2020 Nov 25;38(50):7892-7896. doi: 10.1016/j.vaccine.2020.10.064. Epub 2020 Oct 23.