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Combination Respiratory Vaccine Containing Recombinant SARS-CoV-2 Spike and Quadrivalent Seasonal Influenza Hemagglutinin Nanoparticles with Matrix-M Adjuvant

Michael J Massare, Nita Patel, Bin Zhou, Sonia Maciejewski, Rhonda Flores, Mimi Guebre-Xabier, Jing-Hui Tian, Alyse D. Portnoff, Louis Fries, Vivek Shinde, Larry Ellingsworth, Gregory Glenn, Gale Smith
doi: https://doi.org/10.1101/2021.05.05.442782
Michael J Massare
Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD 20878, USA
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Nita Patel
Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD 20878, USA
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Bin Zhou
Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD 20878, USA
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Sonia Maciejewski
Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD 20878, USA
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Rhonda Flores
Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD 20878, USA
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Mimi Guebre-Xabier
Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD 20878, USA
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Jing-Hui Tian
Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD 20878, USA
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Alyse D. Portnoff
Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD 20878, USA
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Louis Fries
Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD 20878, USA
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Vivek Shinde
Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD 20878, USA
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Larry Ellingsworth
Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD 20878, USA
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Gregory Glenn
Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD 20878, USA
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Gale Smith
Novavax, Inc. 21 Firstfield Road, Gaithersburg, MD 20878, USA
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  • For correspondence: gsmith@novavax.com
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Abstract

The 2019 outbreak of a severe respiratory disease caused by an emerging coronavirus, SARS-CoV-2, has spread globally with high morbidity and mortality. Co-circulating seasonal influenza has greatly diminished recently, but expected to return with novel strains emerging, thus requiring annual strain adjustments. We have developed a recombinant hemagglutinin (HA) quadrivalent nanoparticle influenza vaccine (qNIV) produced using an established recombinant insect cell expression system to produce nanoparticles. Influenza qNIV adjuvanted with Matrix-M was well-tolerated and induced robust antibody and cellular responses, notably against both homologous and drifted A/H3N2 viruses in Phase 1, 2, and 3 trials. We also developed a full-length SARS-CoV-2 spike protein vaccine which is stable in the prefusion conformation (NVX-CoV2373) using the same platform technology. In phase 3 clinical trials, NVX-CoV2373 is highly immunogenic and protective against the prototype strain and B.1.1.7 variant. Here we describe the immunogenicity and efficacy of a combination quadrivalent seasonal flu and COVID-19 vaccine (qNIV/CoV2373) in ferret and hamster models. The combination qNIV/CoV2373 vaccine produces high titer influenza hemagglutination inhibiting (HAI) and neutralizing antibodies against influenza A and B strains. The combination vaccine also elicited antibodies that block SARS-CoV-2 spike protein binding to the human angiotensin converting enzyme-2 (hACE2) receptor. Significantly, hamsters immunized with qNIV/CoV2373 vaccine and challenged with SARS-CoV-2 were protected against weight loss and were free of replicating SARS-CoV-2 in the upper and lower respiratory tract with no evidence of viral pneumonia. This study supports evaluation of qNIV/CoV2373 combination vaccine as a preventive measure for seasonal influenza and CoVID-19.

Highlights

  • Combination qNIV/CoV2373 vaccine induced protective hemagglutination inhibition (HAI) responses to seasonal influenza A and B unchanged when formulated with recombinant spike.

  • Combination qNIV/CoV2373 vaccine maintained clinical and virologic protection against experimental challenge with SARS-CoV-2.

  • Combination qNIV/CoV2373 vaccine showed no clinical or histological sign of enhanced disease following experimental challenge with SARS-CoV-2.

  • Combination qNIV/CoV2373 vaccine induced antibodies against SARS-CoV-2 neutralizing epitopes common between US-WA and B.1.352 variant.

Competing Interest Statement

Authors MM, NP, BZ, SM, RF, MGX, JHT, AP, LF, VS, LE, GG, and GS are current or past employees of Novavax, Inc.

Copyright 
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 May 05, 2021.
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Combination Respiratory Vaccine Containing Recombinant SARS-CoV-2 Spike and Quadrivalent Seasonal Influenza Hemagglutinin Nanoparticles with Matrix-M Adjuvant
Michael J Massare, Nita Patel, Bin Zhou, Sonia Maciejewski, Rhonda Flores, Mimi Guebre-Xabier, Jing-Hui Tian, Alyse D. Portnoff, Louis Fries, Vivek Shinde, Larry Ellingsworth, Gregory Glenn, Gale Smith
bioRxiv 2021.05.05.442782; doi: https://doi.org/10.1101/2021.05.05.442782
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Combination Respiratory Vaccine Containing Recombinant SARS-CoV-2 Spike and Quadrivalent Seasonal Influenza Hemagglutinin Nanoparticles with Matrix-M Adjuvant
Michael J Massare, Nita Patel, Bin Zhou, Sonia Maciejewski, Rhonda Flores, Mimi Guebre-Xabier, Jing-Hui Tian, Alyse D. Portnoff, Louis Fries, Vivek Shinde, Larry Ellingsworth, Gregory Glenn, Gale Smith
bioRxiv 2021.05.05.442782; doi: https://doi.org/10.1101/2021.05.05.442782

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