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1. Immune correlates of protection by mRNA-1273 vaccine against SARS-CoV-2 in nonhuman primates

Author

Ian N. Moore, Seyhan Boyoglu-Barnum, Swagata Kar, Bianca M. Nagata, Shayne F. Andrew, Joseph R. Francica, John R. Mascola, Shruti N. Shah, Darin K. Edwards, Samantha J. Provost, Barney S. Graham, John Paul Todd, Venkata Viswanadh Edara, Eun Sung Yang, Daniel Valentin, Katelyn Steingrebe, David C. Montefiori, Andrea Carfi, Maciel Porto, Hanne Leth Andersen, Robert A. Seder, Kizzmekia S. Corbett, Wei Shi, Jack Greenhouse, Mark G. Lewis, Evan Lamb, Adrian B. McDermott, Daniel C. Douek, Serge Zouantcha, Kathryn E. Foulds, Nancy J. Sullivan, Mahnaz Minai, Kevin W. Bock, Britta Flach, Lilin Lai, Katharine Floyd, Angela Choi, Charlene McDanal, Jonathan Fintzi, Alan Dodson, Matthew A. Koch, Mario Roederer, Amy T. Noe, Juan I. Moliva, Saule T. Nurmukhambetova, Mitzi M. Donaldson, Laurent Pessaint, Timothy S. Johnston, Andrew Faudree, Anne P. Werner, Mehul S. Suthar, Barbara J. Flynn, Kai Wu, Anthony L. Cook, Sarah O’Connell, Gabriela S. Alvarado, Lingshu Wang, Yi Zhang, Martha Nason, Dillon R. Flebbe, Matthew Gagne, Olubukola M. Abiona, Renee van de Wetering, and Kwanyee Leung

Subjects
0301 basic medicine, Multidisciplinary, biology, Surrogate endpoint, business.industry, Immunogenicity, respiratory system, Vaccine efficacy, Article, Vaccination, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Vaccine Potency, Immunization, Viral replication, Immunology, biology.protein, Medicine, 030212 general & internal medicine, Antibody, business
Abstract

Immune correlates of protection can be used as surrogate endpoints for vaccine efficacy. The nonhuman primate (NHP) model of SARS-CoV-2 infection replicates key features of human infection and may be used to define immune correlates of protection following vaccination. Here, NHP received either no vaccine or doses ranging from 0.3 - 100 μg of mRNA-1273, a mRNA vaccine encoding the prefusion-stabilized SARS-CoV-2 spike (S-2P) protein encapsulated in a lipid nanoparticle. mRNA-1273 vaccination elicited robust circulating and mucosal antibody responses in a dose-dependent manner. Viral replication was significantly reduced in bronchoalveolar lavages and nasal swabs following SARS-CoV-2 challenge in vaccinated animals and was most strongly correlated with levels of anti-S antibody binding and neutralizing activity. Consistent with antibodies being a correlate of protection, passive transfer of vaccine-induced IgG to naïve hamsters was sufficient to mediate protection. Taken together, these data show that mRNA-1273 vaccine-induced humoral immune responses are a mechanistic correlate of protection against SARS-CoV-2 infection in NHP.mRNA-1273 vaccine-induced antibody responses are a mechanistic correlate of protection against SARS-CoV-2 infection in NHP.

Published
2021
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2. Immune Correlates of Protection by mRNA-1273 Immunization against SARS-CoV-2 Infection in Nonhuman Primates

Author

Kizzmekia S. Corbett, Martha C. Nason, Britta Flach, Matthew Gagne, Sarah O’ Connell, Timothy S. Johnston, Shruti N. Shah, Venkata Viswanadh Edara, Katharine Floyd, Lilin Lai, Charlene McDanal, Joseph R. Francica, Barbara Flynn, Kai Wu, Angela Choi, Matthew Koch, Olubukola M. Abiona, Anne P. Werner, Gabriela S. Alvarado, Shayne F. Andrew, Mitzi M. Donaldson, Jonathan Fintzi, Dillon R. Flebbe, Evan Lamb, Amy T. Noe, Saule T. Nurmukhambetova, Samantha J. Provost, Anthony Cook, Alan Dodson, Andrew Faudree, Jack Greenhouse, Swagata Kar, Laurent Pessaint, Maciel Porto, Katelyn Steingrebe, Daniel Valentin, Serge Zouantcha, Kevin W. Bock, Mahnaz Minai, Bianca M. Nagata, Juan I. Moliva, Renee van de Wetering, Seyhan Boyoglu-Barnum, Kwanyee Leung, Wei Shi, Eun Sung Yang, Yi Zhang, John-Paul M. Todd, Lingshu Wang, Hanne Andersen, Kathryn E. Foulds, Darin K. Edwards, John R. Mascola, Ian N. Moore, Mark G. Lewis, Andrea Carfi, David Montefiori, Mehul S. Suthar, Adrian McDermott, Nancy J. Sullivan, Mario Roederer, Daniel C. Douek, Barney S. Graham, and Robert A. Seder

Subjects
CD4-Positive T-Lymphocytes, Male, COVID-19 Vaccines, Antibody Affinity, Immunization, Secondary, Antibodies, Viral, Virus Replication, Article, Immunogenicity, Vaccine, Immune system, Animals, Medicine, Lung, Vaccine Potency, Immunization Schedule, Messenger RNA, Mesocricetus, biology, SARS-CoV-2, business.industry, Surrogate endpoint, Vaccination, Immunization, Passive, COVID-19, Vaccine efficacy, Antibodies, Neutralizing, Macaca mulatta, Nasal Mucosa, Viral replication, Immunization, Immunoglobulin G, Spike Glycoprotein, Coronavirus, Immunology, biology.protein, Female, Antibody, business, Bronchoalveolar Lavage Fluid, Immunologic Memory, 2019-nCoV Vaccine mRNA-1273
Abstract

Immune correlates of protection can be used as surrogate endpoints for vaccine efficacy. The nonhuman primate (NHP) model of SARS-CoV-2 infection replicates key features of human infection and may be used to define immune correlates of protection following vaccination. Here, NHP received either no vaccine or doses ranging from 0.3 – 100 μg of mRNA-1273, a mRNA vaccine encoding the prefusion-stabilized SARS-CoV-2 spike (S-2P) protein encapsulated in a lipid nanoparticle. mRNA-1273 vaccination elicited robust circulating and mucosal antibody responses in a dose-dependent manner. Viral replication was significantly reduced in bronchoalveolar lavages and nasal swabs following SARS-CoV-2 challenge in vaccinated animals and was most strongly correlated with levels of anti-S antibody binding and neutralizing activity. Consistent with antibodies being a correlate of protection, passive transfer of vaccine-induced IgG to naïve hamsters was sufficient to mediate protection. Taken together, these data show that mRNA-1273 vaccine-induced humoral immune responses are a mechanistic correlate of protection against SARS-CoV-2 infection in NHP.One-Sentence SummarymRNA-1273 vaccine-induced antibody responses are a mechanistic correlate of protection against SARS-CoV-2 infection in NHP.

Published
2021
Full Text
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