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

  1. Mimi Guebre-Xabier
  2. Nita Patel
  3. Jing-Hui Tian
  4. Bin Zhou
  5. Sonia Maciejewski
  6. Kristal Lam
  7. Alyse D. Portnoff
  8. Michael J. Massare
  9. Matthew B. Frieman
  10. Pedro A. Piedra
  11. Larry Ellingsworth
  12. Gregory Glenn
  13. Gale Smith
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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 ( <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04368988">NCT04368988</ext-link> ).

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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