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SARS-CoV-2 spike glycoprotein vaccine candidate NVX-CoV2373 elicits immunogenicity in baboons and protection in mice

Jing-Hui Tian, Nita Patel, Robert Haupt, Haixia Zhou, Stuart Weston, Holly Hammond, James Lague, Alyse D. Portnoff, James Norton, Mimi Guebre-Xabier, Bin Zhou, Kelsey Jacobson, Sonia Maciejewski, Rafia Khatoon, Malgorzata Wisniewska, Will Moffitt, Stefanie Kluepfel-Stahl, Betty Ekechukwu, James Papin, Sarathi Boddapati, C. Jason Wong, Pedro A. Piedra, Matthew B. Frieman, Michael J. Massare, Louis Fries, Karin Lövgren Bengtsson, Linda Stertman, Larry Ellingsworth, Gregory Glenn, Gale Smith
doi: https://doi.org/10.1101/2020.06.29.178509
Jing-Hui Tian
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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  • For correspondence: jhtian@Novavax.com npatel@novavax.com hzhou@novavax.com aportnoff@Novavax.com jnorton@Novavax.com mguebre-xabier@Novavax.com bzhou@Novavax.com kjacobson@Novavax.com SMaciejewski@Novavax.com rkhatoon@Novavax.com mwisniewska@Novavax.com wmoffitt@Novavax.com skluepfel-stahl@Novavax.com bekechukwu@Novavax.com MMassare@Novavax.com lfries@Novavax.com lellingsworth@novavax.com gglenn@Novavax.com GSmith@Novavax.com
Nita Patel
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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  • For correspondence: jhtian@Novavax.com npatel@novavax.com hzhou@novavax.com aportnoff@Novavax.com jnorton@Novavax.com mguebre-xabier@Novavax.com bzhou@Novavax.com kjacobson@Novavax.com SMaciejewski@Novavax.com rkhatoon@Novavax.com mwisniewska@Novavax.com wmoffitt@Novavax.com skluepfel-stahl@Novavax.com bekechukwu@Novavax.com MMassare@Novavax.com lfries@Novavax.com lellingsworth@novavax.com gglenn@Novavax.com GSmith@Novavax.com
Robert Haupt
2University of Maryland, School of Medicine, 685 West Baltimore St, Baltimore, MD 21201, USA. . (M.B.F., R.H., S.W., H.H.)
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Haixia Zhou
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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Stuart Weston
2University of Maryland, School of Medicine, 685 West Baltimore St, Baltimore, MD 21201, USA. . (M.B.F., R.H., S.W., H.H.)
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Holly Hammond
2University of Maryland, School of Medicine, 685 West Baltimore St, Baltimore, MD 21201, USA. . (M.B.F., R.H., S.W., H.H.)
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James Lague
2University of Maryland, School of Medicine, 685 West Baltimore St, Baltimore, MD 21201, USA. . (M.B.F., R.H., S.W., H.H.)
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Alyse D. Portnoff
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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James Norton
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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Mimi Guebre-Xabier
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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Bin Zhou
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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Kelsey Jacobson
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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Sonia Maciejewski
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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Rafia Khatoon
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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Malgorzata Wisniewska
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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Will Moffitt
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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Stefanie Kluepfel-Stahl
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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Betty Ekechukwu
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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James Papin
3University of Oklahoma, Health Sciences Center, Department of Pathology, Division of Comparative Medicine, 940 Stanton L. Young, BMS 203, Oklahoma City, OK, 73104 USA. Email: (J.P.)
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Sarathi Boddapati
4Catalent Paragon Gene Therapy, 801 West Baltimore Street, Baltimore, MD 21201. USA. (S.B.), (C.J.W.)
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C. Jason Wong
4Catalent Paragon Gene Therapy, 801 West Baltimore Street, Baltimore, MD 21201. USA. (S.B.), (C.J.W.)
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Pedro A. Piedra
5Department of Molecular Virology and Microbiology, and Pediatrics, Baylor College of Medicine, Houston, Texas. (P.A.P.)
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Matthew B. Frieman
2University of Maryland, School of Medicine, 685 West Baltimore St, Baltimore, MD 21201, USA. . (M.B.F., R.H., S.W., H.H.)
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Michael J. Massare
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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Louis Fries
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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Karin Lövgren Bengtsson
6Novavax AB, Kungsgatan 109, Uppsala, SE-753 18, SE. (K.L.B.), (L.S.)
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Linda Stertman
6Novavax AB, Kungsgatan 109, Uppsala, SE-753 18, SE. (K.L.B.), (L.S.)
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Larry Ellingsworth
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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Gregory Glenn
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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Gale Smith
1Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD, 20878, USA. (J.H.T.), (N.P.), (H.Z.), (A.D.P.), (J.M), (M.G.X.), (B.Z.), (K.J.), (S.M.), (R.K.), (M.W.), (W.M.), (S.K.S.), (B.E.), (M.J.M.), (L.F.), (L.E.), (G.G.), (G.S.)
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  • For correspondence: GSmith@Novavax.com jhtian@Novavax.com npatel@novavax.com hzhou@novavax.com aportnoff@Novavax.com jnorton@Novavax.com mguebre-xabier@Novavax.com bzhou@Novavax.com kjacobson@Novavax.com SMaciejewski@Novavax.com rkhatoon@Novavax.com mwisniewska@Novavax.com wmoffitt@Novavax.com skluepfel-stahl@Novavax.com bekechukwu@Novavax.com MMassare@Novavax.com lfries@Novavax.com lellingsworth@novavax.com gglenn@Novavax.com GSmith@Novavax.com
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Abstract

The COVID-19 pandemic continues to spread throughout the world with an urgent need for a safe and protective vaccine to effectuate herd immunity to control the spread of SARS-CoV-2. Here, we report the development of a SARS-CoV-2 subunit vaccine (NVX-CoV2373) produced from the full-length spike (S) protein, stabilized in the prefusion conformation. Purified NVX-CoV2373 S form 27.2nm nanoparticles that are thermostable and bind with high affinity to the human angiotensin-converting enzyme 2 (hACE2) receptor. In mice and baboons, low-dose NVX-CoV2373 with saponin-based Matrix-M adjuvant elicits high titer anti-S IgG that is associated with blockade of hACE2 receptor binding, virus neutralization, and protection against SARS-CoV-2 challenge in mice with no evidence of vaccine-associated enhanced respiratory disease (VAERD). NVX-CoV2373 vaccine also elicits multifunctional CD4+ and CD8+ T cells, CD4+ T follicular helper T cells (Tfh), and the generation of antigen-specific germinal center (GC) B cells in the spleen. These results support the ongoing phase 1/2 clinical evaluation of the safety and immunogenicity of NVX-CoV2327 with Matrix-M (NCT04368988).

Competing Interest Statement

GS, GG, JHT, NP, RH, HZ, MGX, ADP, MJM, MBF and LE contributed to conceptualization of experiments, generation of data and analysis, and interpretation of the results. JHT, RH, NP, SW, HH, JL, JN, BZ, KJ, SM, RK, MW, WM, SKS, BE, SB, CJW, HZ performed experiments. ADP, MGX, JP coordinated projects. MBF, ADP, MJM, LF, PAP, KLB, LS, GG, GS, LE contributed to drafting and making critical revisions with the help of others.

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The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.
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Posted June 30, 2020.
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SARS-CoV-2 spike glycoprotein vaccine candidate NVX-CoV2373 elicits immunogenicity in baboons and protection in mice
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SARS-CoV-2 spike glycoprotein vaccine candidate NVX-CoV2373 elicits immunogenicity in baboons and protection in mice
Jing-Hui Tian, Nita Patel, Robert Haupt, Haixia Zhou, Stuart Weston, Holly Hammond, James Lague, Alyse D. Portnoff, James Norton, Mimi Guebre-Xabier, Bin Zhou, Kelsey Jacobson, Sonia Maciejewski, Rafia Khatoon, Malgorzata Wisniewska, Will Moffitt, Stefanie Kluepfel-Stahl, Betty Ekechukwu, James Papin, Sarathi Boddapati, C. Jason Wong, Pedro A. Piedra, Matthew B. Frieman, Michael J. Massare, Louis Fries, Karin Lövgren Bengtsson, Linda Stertman, Larry Ellingsworth, Gregory Glenn, Gale Smith
bioRxiv 2020.06.29.178509; doi: https://doi.org/10.1101/2020.06.29.178509
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SARS-CoV-2 spike glycoprotein vaccine candidate NVX-CoV2373 elicits immunogenicity in baboons and protection in mice
Jing-Hui Tian, Nita Patel, Robert Haupt, Haixia Zhou, Stuart Weston, Holly Hammond, James Lague, Alyse D. Portnoff, James Norton, Mimi Guebre-Xabier, Bin Zhou, Kelsey Jacobson, Sonia Maciejewski, Rafia Khatoon, Malgorzata Wisniewska, Will Moffitt, Stefanie Kluepfel-Stahl, Betty Ekechukwu, James Papin, Sarathi Boddapati, C. Jason Wong, Pedro A. Piedra, Matthew B. Frieman, Michael J. Massare, Louis Fries, Karin Lövgren Bengtsson, Linda Stertman, Larry Ellingsworth, Gregory Glenn, Gale Smith
bioRxiv 2020.06.29.178509; doi: https://doi.org/10.1101/2020.06.29.178509

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