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Safety, immunogenicity and protection provided by unadjuvanted and adjuvanted formulations of recombinant plant-derived virus-like particle vaccine candidate for COVID-19 in non-human primates

Stéphane Pillet, Prabhu S. Arunachalam, Guadalupe Andreani, Nadia Golden, Jane Fontenot, Pyone Aye, Katharina Röltgen, Gabrielle Lehmick, Charlotte Dubé, Philipe Gobeil, Sonia Trépanier, Nathalie Charland, Marc-André D’Aoust, Kasi Russell-Lodrigue, Robert V. Blair, Scott Boyd, Rudolph B. Bohm, Jay Rappaport, François Villinger, Brian J. Ward, View ORCID ProfileBali Pulendran, View ORCID ProfileNathalie Landry
doi: https://doi.org/10.1101/2021.05.15.444262
Stéphane Pillet
1Medicago Inc., Québec, QC, Canada
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Prabhu S. Arunachalam
2Institute for Immunity, Transplantation and Infection, Stanford University School of Medicine, Stanford University, Stanford, CA, USA
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Guadalupe Andreani
1Medicago Inc., Québec, QC, Canada
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Nadia Golden
3Tulane National Primate Research Center, Covington, LA, USA
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Jane Fontenot
4New Iberia Research Center, University of Louisiana at Lafayette, New Iberia, LA, USA
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Pyone Aye
3Tulane National Primate Research Center, Covington, LA, USA
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Katharina Röltgen
5Department of Pathology, Stanford University School of Medicine, Stanford University, Stanford, CA, USA
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Gabrielle Lehmick
3Tulane National Primate Research Center, Covington, LA, USA
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Charlotte Dubé
1Medicago Inc., Québec, QC, Canada
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Philipe Gobeil
1Medicago Inc., Québec, QC, Canada
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Sonia Trépanier
1Medicago Inc., Québec, QC, Canada
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Nathalie Charland
1Medicago Inc., Québec, QC, Canada
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Marc-André D’Aoust
1Medicago Inc., Québec, QC, Canada
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Kasi Russell-Lodrigue
3Tulane National Primate Research Center, Covington, LA, USA
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Robert V. Blair
3Tulane National Primate Research Center, Covington, LA, USA
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Scott Boyd
5Department of Pathology, Stanford University School of Medicine, Stanford University, Stanford, CA, USA
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Rudolph B. Bohm
3Tulane National Primate Research Center, Covington, LA, USA
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Jay Rappaport
3Tulane National Primate Research Center, Covington, LA, USA
6Department of Microbiology and Immunology, Tulane University School of Medicine, New Orleans, LA, USA
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François Villinger
4New Iberia Research Center, University of Louisiana at Lafayette, New Iberia, LA, USA
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Brian J. Ward
1Medicago Inc., Québec, QC, Canada
7Research Institute of the McGill University Health Centre, Montreal, QC, Canada
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Bali Pulendran
2Institute for Immunity, Transplantation and Infection, Stanford University School of Medicine, Stanford University, Stanford, CA, USA
5Department of Pathology, Stanford University School of Medicine, Stanford University, Stanford, CA, USA
8Department of Microbiology and Immunology, Stanford University School of Medicine, Stanford University, Stanford, CA, USA
9Institute for Immunity, Transplantation & Infection, Stanford University School of Medicine, Stanford University, Stanford, CA, USA
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Nathalie Landry
1Medicago Inc., Québec, QC, Canada
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  • ORCID record for Nathalie Landry
  • For correspondence: landryn@medicago.com
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Abstract

Although antivirals are important tools to control the SARS-CoV-2 infection, effective vaccines are essential to control the current pandemic. Plant-derived virus-like particle (VLP) vaccine candidates have previously demonstrated immunogenicity and efficacy against influenza. Here we report the immunogenicity and protection induced in macaques by intramuscular injections of VLP bearing SARS-CoV-2 spike protein (CoVLP) vaccine candidate formulated with or without Adjuvant System 03 (AS03) or cytosine phosphoguanine (CpG) 1018. Although a single dose of unadjuvanted CoVLP vaccine candidate stimulated humoral and cell-mediated immune responses, booster immunization (at 28 days after prime) and adjuvants significantly improved both responses with a higher immunogenicity and protection provided by AS03 adjuvanted CoVLP. Fifteen microgram CoVLP adjuvanted with AS03 induced a balanced IL-2 driven response along with IL-4 expression in CD4 T cells and mobilization of CD4 follicular helper cells (Tfh). Animals were challenged by multiple routes (i.e. intratracheal, intranasal and ocular) with a total viral dose of 106 plaque forming units of SARS-CoV-2. Lower viral replication in nasal swabs and broncho-alveolar lavage (BAL) as well as fewer SARS-CoV-2 infected cells and immune cell infiltrates in the lungs concomitant with reduced levels of pro-inflammatory cytokines and chemotactic factors in BAL were observed in the animals immunized with CoVLP adjuvanted with AS03. No clinical, pathologic or virologic evidences of vaccine associated enhanced disease (VAED) were observed in vaccinated animals. CoVLP adjuvanted with AS03 was therefore selected for vaccine development and clinical trials.

Competing Interest Statement

SP, GA, CD, PG, ST, NC, MAD, BJW and NL are either employees of Medicago Inc or receive salary support from Medicago Inc. NIRC, TNPRC and Stanford University received payments or financial compensations from Medicago Inc for the services they provided in this study.

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 15, 2021.
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Safety, immunogenicity and protection provided by unadjuvanted and adjuvanted formulations of recombinant plant-derived virus-like particle vaccine candidate for COVID-19 in non-human primates
Stéphane Pillet, Prabhu S. Arunachalam, Guadalupe Andreani, Nadia Golden, Jane Fontenot, Pyone Aye, Katharina Röltgen, Gabrielle Lehmick, Charlotte Dubé, Philipe Gobeil, Sonia Trépanier, Nathalie Charland, Marc-André D’Aoust, Kasi Russell-Lodrigue, Robert V. Blair, Scott Boyd, Rudolph B. Bohm, Jay Rappaport, François Villinger, Brian J. Ward, Bali Pulendran, Nathalie Landry
bioRxiv 2021.05.15.444262; doi: https://doi.org/10.1101/2021.05.15.444262
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Safety, immunogenicity and protection provided by unadjuvanted and adjuvanted formulations of recombinant plant-derived virus-like particle vaccine candidate for COVID-19 in non-human primates
Stéphane Pillet, Prabhu S. Arunachalam, Guadalupe Andreani, Nadia Golden, Jane Fontenot, Pyone Aye, Katharina Röltgen, Gabrielle Lehmick, Charlotte Dubé, Philipe Gobeil, Sonia Trépanier, Nathalie Charland, Marc-André D’Aoust, Kasi Russell-Lodrigue, Robert V. Blair, Scott Boyd, Rudolph B. Bohm, Jay Rappaport, François Villinger, Brian J. Ward, Bali Pulendran, Nathalie Landry
bioRxiv 2021.05.15.444262; doi: https://doi.org/10.1101/2021.05.15.444262

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