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SARS-CoV-2 Vaccines Elicit Durable Immune Responses in Infant Rhesus Macaques

Carolina Garrido, Alan D. Curtis II, Maria Dennis, Sachi H. Pathak, Hongmei Gao, David Montefiori, Mark Tomai, Christopher B. Fox, Pamela A. Kozlowski, Trevor Scobey, Jennifer E. Munt, Michael L. Mallroy, Pooja T. Saha, Michael G. Hudgens, Lisa C. Lindesmith, Ralph S. Baric, Olubukola M. Abiona, Barney Graham, Kizzmekia S. Corbett, Darin Edwards, Andrea Carfi, Genevieve Fouda, Koen K. A. Van Rompay, Kristina De Paris, Sallie R. Permar
doi: https://doi.org/10.1101/2021.04.05.438479
Carolina Garrido
1Duke University Medical Center, Duke Human Vaccine Institute, Durham, NC, USA
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Alan D. Curtis II
2Department of Microbiology and Immunology, Center for AIDS Research, and Children’s Research Institute, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
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Maria Dennis
1Duke University Medical Center, Duke Human Vaccine Institute, Durham, NC, USA
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Sachi H. Pathak
2Department of Microbiology and Immunology, Center for AIDS Research, and Children’s Research Institute, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
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Hongmei Gao
1Duke University Medical Center, Duke Human Vaccine Institute, Durham, NC, USA
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David Montefiori
1Duke University Medical Center, Duke Human Vaccine Institute, Durham, NC, USA
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Mark Tomai
33M Corporate Research Materials Laboratory, Saint Paul, MN, USA
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Christopher B. Fox
4Infectious Disease Research Institute, Seattle, WA, USA
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Pamela A. Kozlowski
5Department of Microbiology, Immunology and Parasitology, Louisiana State University Health Sciences Center, New Orleans, LA, USA
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Trevor Scobey
6Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
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Jennifer E. Munt
6Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
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Michael L. Mallroy
6Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
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Pooja T. Saha
7Department of Biostatistics, Gillings School of Global Public Health, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
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Michael G. Hudgens
7Department of Biostatistics, Gillings School of Global Public Health, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
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Lisa C. Lindesmith
6Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
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Ralph S. Baric
6Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
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Olubukola M. Abiona
8Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MA, USA
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Barney Graham
8Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MA, USA
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Kizzmekia S. Corbett
8Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MA, USA
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Darin Edwards
9Moderna, Inc., Cambridge, MA, USA
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Andrea Carfi
9Moderna, Inc., Cambridge, MA, USA
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Genevieve Fouda
1Duke University Medical Center, Duke Human Vaccine Institute, Durham, NC, USA
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Koen K. A. Van Rompay
10California National Primate Research Center, University of California, Davis, CA, USA
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Kristina De Paris
2Department of Microbiology and Immunology, Center for AIDS Research, and Children’s Research Institute, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
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  • For correspondence: abelk@med.unc.edu
Sallie R. Permar
11Cornell Weill Medical College, New York, NY, USA
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Abstract

Early life SARS-CoV-2 vaccination has the potential to provide lifelong protection and achieve herd immunity. To evaluate SARS-CoV-2 infant vaccination, we immunized two groups of 8 infant rhesus macaques (RMs) at weeks 0 and 4 with stabilized prefusion SARS-CoV-2 S-2P spike (S) protein, either encoded by mRNA encapsulated in lipid nanoparticles (mRNA-LNP) or mixed with 3M-052-SE, a TLR7/8 agonist in a squalene emulsion (Protein+3M-052-SE). Neither vaccine induced adverse effects. High magnitude S-binding IgG and neutralizing infectious dose 50 (ID50) >103 were elicited by both vaccines. S-specific T cell responses were dominated by IL-17, IFN-γ, or TNF-α. Antibody and cellular responses were stable through week 22. The S-2P mRNA-LNP and Protein-3M-052-SE vaccines are promising pediatric SARS-CoV-2 vaccine candidates to achieve durable protective immunity.

One-Sentence Summary SARS-CoV-2 vaccines are well-tolerated and highly immunogenic in infant rhesus macaques

Competing Interest Statement

A. Carfi, and D. Edwards are employees of Moderna Inc. and hold equities from the company. B. S. Graham and K. S. Corbett are inventors on Patent Applications: EP Patent Application 17800655.7 filed 13 May 2019, entitled Prefusion coronavirus spike proteins and their use; US Patent Application 16/344,774 filed 24 April 2019 entitled Prefusion coronavirus spike proteins and their use [HHS Ref. No. E-234-2016-1-US-03]. O. M. Abiona, B. S. Graham and K. S. Corbett are inventors on the Patent Application: US Provisional Patent Application 62/972,886 filed 11 February 2020 entitled 2019-nCoV Vaccine. Dr. Permar has sponsored programs and consults with Merck and Moderna for their CMV vaccine programs. C.B. Fox is an inventor on US patent application 2017/032756, PEGylated Lysosmes and Methods of Use.

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 April 06, 2021.
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SARS-CoV-2 Vaccines Elicit Durable Immune Responses in Infant Rhesus Macaques
Carolina Garrido, Alan D. Curtis II, Maria Dennis, Sachi H. Pathak, Hongmei Gao, David Montefiori, Mark Tomai, Christopher B. Fox, Pamela A. Kozlowski, Trevor Scobey, Jennifer E. Munt, Michael L. Mallroy, Pooja T. Saha, Michael G. Hudgens, Lisa C. Lindesmith, Ralph S. Baric, Olubukola M. Abiona, Barney Graham, Kizzmekia S. Corbett, Darin Edwards, Andrea Carfi, Genevieve Fouda, Koen K. A. Van Rompay, Kristina De Paris, Sallie R. Permar
bioRxiv 2021.04.05.438479; doi: https://doi.org/10.1101/2021.04.05.438479
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SARS-CoV-2 Vaccines Elicit Durable Immune Responses in Infant Rhesus Macaques
Carolina Garrido, Alan D. Curtis II, Maria Dennis, Sachi H. Pathak, Hongmei Gao, David Montefiori, Mark Tomai, Christopher B. Fox, Pamela A. Kozlowski, Trevor Scobey, Jennifer E. Munt, Michael L. Mallroy, Pooja T. Saha, Michael G. Hudgens, Lisa C. Lindesmith, Ralph S. Baric, Olubukola M. Abiona, Barney Graham, Kizzmekia S. Corbett, Darin Edwards, Andrea Carfi, Genevieve Fouda, Koen K. A. Van Rompay, Kristina De Paris, Sallie R. Permar
bioRxiv 2021.04.05.438479; doi: https://doi.org/10.1101/2021.04.05.438479

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