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

Mimi Guebre-Xabier; Nita Patel; Jing-Hui Tian; Bin Zhou; Sonia Maciejewski; Kristal Lam; Alyse D Portnoff; Michael J Massare; Matthew B Frieman; Pedro A Piedra; Larry Ellingsworth; Gregory Glenn; Gale Smith

doi:10.1016/j.vaccine.2020.10.064

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

Vaccine. 2020 Nov 25;38(50):7892-7896. doi: 10.1016/j.vaccine.2020.10.064. Epub 2020 Oct 23.

Authors

Affiliations

¹ Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: mguebre-xabier@Novavax.com.
² Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: npatel@novavax.com.
³ Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: jhtian@Novavax.com.
⁴ Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: bzhou@Novavax.com.
⁵ Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: smaciejewski@Novavavax.com.
⁶ Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: klam@Novavax.com.
⁷ Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: aportnoff@Novavax.com.
⁸ Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: mmassare@Novavax.com.
⁹ University of Maryland, School of Medicine, 685 West Baltimore St, Baltimore, MD 21201, USA. Electronic address: mfrieman@som.umaryland.edu.
¹⁰ Department of Molecular Virology and Microbiology, and Pediatrics, Baylor College of Medicine, Houston, TX, USA. Electronic address: ppiedra@bcm.edu.
¹¹ Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: lellingsworth@novavax.com.
¹² Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: gglenn@Novavax.com.
¹³ Novavax, Inc., 21 Firstfield Road, Gaithersburg, MD 20878, USA. Electronic address: gsmith@Novavax.com.

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).

Keywords: COVID-19; Matrix-M adjuvant; NVX-CoV2373 nanoparticles; Nonhuman primate; SARS-CoV-2; Spike glycoprotein.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adjuvants, Immunologic / pharmacology
Adolescent
Adult
Aged
Angiotensin-Converting Enzyme 2 / immunology
Angiotensin-Converting Enzyme 2 / metabolism
Animals
Antibodies, Neutralizing
COVID-19 / immunology
COVID-19 / prevention & control*
COVID-19 Vaccines / genetics
COVID-19 Vaccines / immunology
COVID-19 Vaccines / pharmacology*
Chlorocebus aethiops
Female
Humans
Immune Sera / drug effects
Immune Sera / immunology
Macaca fascicularis
Male
Middle Aged
SARS-CoV-2 / immunology*
Spike Glycoprotein, Coronavirus / genetics
Vaccines, Synthetic / immunology
Vaccines, Synthetic / pharmacology
Vero Cells
Viral Load
Young Adult

Substances

Adjuvants, Immunologic
Antibodies, Neutralizing
COVID-19 Vaccines
Immune Sera
Spike Glycoprotein, Coronavirus
Vaccines, Synthetic
spike protein, SARS-CoV-2
NVX-CoV2373 adjuvated lipid nanoparticle
ACE2 protein, human
Angiotensin-Converting Enzyme 2

Associated data

ClinicalTrials.gov/NCT04368988