Cited by 231SARS-CoV-2 and COVID-19 ResearchAnimal Virus Infections StudiesSARS-CoV-2 detection and testing

NVX-CoV2373 vaccine protects cynomolgus macaque upper and lower airways against SARS-CoV-2 challenge

Open access
Guebre-Xabier, Mimi, Patel, Nita, Tian, Jing-Hui, Zhou, Bin, Maciejewski, Sonia, Lam, Kristal, Portnoff, Alyse D., Massare, Michael J. +5 more·2020·Vaccine

Published version of a preprint

Abstract

ABSTRACT 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 ). Highlights Full-length SARS-CoV-2 prefusion spike with Matrix-M1™ (NVX-CoV2373) vaccine. Induced hACE2 receptor blocking and neutralizing antibodies in macaques. Vaccine protected against SARS-CoV-2 replication in the nose and lungs. Absence of pulmonary pathology in NVX-CoV2373 vaccinated macaques.

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Crossref · 10.1016/j.vaccine.2020.10.064

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  • Preclinical testing of mRNA-1273 and other SARS-CoV-2 vaccines in advanced clinical evaluation has shown a Th1-skewed vaccine response and no pathologic lung infiltrates.

    “Of note, preclinical testing of mRNA-1273 and other SARS-CoV-2 vaccines in advanced clinical evaluation has shown a Th1-skewed vaccine response and no pathologic lung infiltrates. 15,26-28”

    From Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine (2021) · cites this paper as [26]

    The Introduction (page unavailable) reports a Th1-biased response to NVX-CoV2373, and Results > Lung pathology reports little or no lung inflammation in vaccinated macaques. But the Fig. 2 description in that section records infiltrates in the lower-dose groups, so the unqualified claim of no pathologic lung infiltrates overstates the findings. This paper identifies mRNA-1273 as another vaccine studied in macaques but does not report these outcomes for mRNA-1273. (LLM, conf=0.88)

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Research works printed but not linked: 3

  1. [1]Jing-Hui Tian, Nita Patel, Robert Haupt, Haixia Zhou, Stuart Weston, Holly Hammond, et al. SARS-CoV-2 spike glycoprotein vaccine candidate NVX-CoV2373 elicits immunogenicity in baboons and protection in mice. bioRxiv 2020; doi: https://doi.org/10.1101/2020.06.29.178509. PMC7809486 33446655 · DOI
  2. [8]Neeltje van Doremalen, Teresa Lambe, Alexandra Spencer, Sandra Belij-Rammerstorfer, Jyothi N. Purushotham, Julia R. Port, et al. ChAdOx1 nCoV-19 vaccination prevents SARS-CoV-2 pneumonia in rhesus macaques. bioRXiv. 2020; https://doi:10.1101/2020.05.13.093195. PMC8436420 32731258 · DOI · Paper page
  3. [9]Yu J. Tostanoski L.H. Peter L. Mercado N.B. McMahan K. Mahrokhian S.H. Nkolola J.P. Liu J. Li Z. Chandrashekar A. Martinez D.R. Loos C. Atyeo C. Fischinger S. Burke J.S. Slein M.D. Chen Y. Zuiani A. Lelis F.J.N. Travers M. Habibi S. Pessaint L. Van Ry A. Blade K. Brown R. Cook A. Finneyfrock B. Dodson A. Teow E. Velasco J. Zahn R. Wegmann F. Bondzie E.A. Dagotto G. Gebre M.S. He X. Jacob-Dolan C. Kirilova M. Kordana N. Lin Z. Maxfield L.F. Nampanya F. Nityanandam R. Ventura J.D. Wan H. Cai Y. Chen B. Schmidt A.G. Wesemann D.R. Baric R.S. Alter G. Andersen H. Lewis M.G. Barouch D.H. DNA vaccine protection against SARS-CoV-2 in rhesus macaques Science 369 6505 2020 806 811 10.1126/science:abc6284 32434945 PMC7243363 · DOI

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Authors
Guebre-Xabier, M., Patel, N., Tian, J.-H., Zhou, B., Maciejewski, S., Lam, K., Portnoff, A. D., Massare, M. J., Frieman, M. B., Piedra, P. A., Ellingsworth, L., Glenn, G., & Smith, G.
Affiliations
  • Novavax (United States) (US)
  • University of Maryland, Baltimore (US)
  • Baylor College of Medicine (US)
Corresponding author
Smith, Gale
Venue
Vaccine
Publisher
Elsevier BV
Published
2020-11
Volume
38
Issue
50
Pages
7892-7896
ISSN
0264-410X (ISSN-L)
OpenAlex
W3094009122
Cited by
231
References
9
Citations by year
2026: 4 · 2025: 9 · 2024: 19 · 2023: 21 · 2022: 49 · 2021: 111 · 2020: 18
FWCI
6.53
Type
journal article
Language
en
Open access
Locations
  • Vaccine (publishedVersion, cc-by-nc-nd)
  • bioRxiv (Cold Spring Harbor Laboratory) (acceptedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
Coalition for Epidemic Preparedness Innovations
Topics
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
  • Life Sciences › Agricultural and Biological Sciences › Animal Science and Zoology › Animal Virus Infections Studies
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 detection and testing
Keywords
NVX-CoV2373, COVID-19 vaccines, subunit vaccine, cynomolgus macaques, Matrix-M adjuvant, saponin adjuvant, neutralizing antibodies, lung disease, intranasal challenge, intratracheal challenge, vaccine immunogenicity, vaccine efficacy
MeSH terms
Angiotensin-Converting Enzyme 2, COVID-19, SARS-CoV-2, COVID-19 Vaccines, Adjuvants, Immunologic, Adolescent, Adult, Aged, Animals, Chlorocebus aethiops, Female, Humans, Immune Sera, Macaca fascicularis, Male, Middle Aged, Vaccines, Synthetic, Vero Cells, Viral Load, Young Adult, Antibodies, Neutralizing, Spike Glycoprotein, Coronavirus

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