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1. Optimization of non-coding regions for a non-modified mRNA COVID-19 vaccine

Author

Gebre, Makda S., Rauch, Susanne, Roth, Nicole, Yu, Jingyou, Chandrashekar, Abishek, Mercado, Noe B., He, Xuan, Liu, Jinyan, McMahan, Katherine, Martinot, Amanda, Martinez, David R., Giffin, Victoria, Hope, David, Patel, Shivani, Sellers, Daniel, Sanborn, Owen, Barrett, Julia, Liu, Xiaowen, Cole, Andrew C., Pessaint, Laurent, Valentin, Daniel, Flinchbaugh, Zack, Yalley-Ogunro, Jake, Muench, Jeanne, Brown, Renita, Cook, Anthony, Teow, Elyse, Andersen, Hanne, Lewis, Mark G., Boon, Adrianus C. M., Baric, Ralph S., Mueller, Stefan O., Petsch, Benjamin, and Barouch, Dan H.

Published
2022
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2. Protective efficacy of Ad26.COV2.S against SARS-CoV-2 B.1.351 in macaques

Author

Yu, Jingyou, Tostanoski, Lisa H., Mercado, Noe B., McMahan, Katherine, Liu, Jinyan, Jacob-Dolan, Catherine, Chandrashekar, Abishek, Atyeo, Caroline, Martinez, David R., Anioke, Tochi, Bondzie, Esther A., Chang, Aiquan, Gardner, Sarah, Giffin, Victoria M., Hope, David L., Nampanya, Felix, Nkolola, Joseph, Patel, Shivani, Sanborn, Owen, Sellers, Daniel, Wan, Huahua, Hayes, Tammy, Bauer, Katherine, Pessaint, Laurent, Valentin, Daniel, Flinchbaugh, Zack, Brown, Renita, Cook, Anthony, Bueno-Wilkerson, Deandre, Teow, Elyse, Andersen, Hanne, Lewis, Mark G., Martinot, Amanda J., Baric, Ralph S., Alter, Galit, Wegmann, Frank, Zahn, Roland, Schuitemaker, Hanneke, and Barouch, Dan H.

Published
2021
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3. Correlates of protection against SARS-CoV-2 in rhesus macaques

Author

McMahan, Katherine, Yu, Jingyou, Mercado, Noe B., Loos, Carolin, Tostanoski, Lisa H., Chandrashekar, Abishek, Liu, Jinyan, Peter, Lauren, Atyeo, Caroline, Zhu, Alex, Bondzie, Esther A., Dagotto, Gabriel, Gebre, Makda S., Jacob-Dolan, Catherine, Li, Zhenfeng, Nampanya, Felix, Patel, Shivani, Pessaint, Laurent, Van Ry, Alex, Blade, Kelvin, Yalley-Ogunro, Jake, Cabus, Mehtap, Brown, Renita, Cook, Anthony, Teow, Elyse, Andersen, Hanne, Lewis, Mark G., Lauffenburger, Douglas A., Alter, Galit, and Barouch, Dan H.

Published
2021
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5. Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques

Author

Mercado, Noe B., Zahn, Roland, Wegmann, Frank, Loos, Carolin, Chandrashekar, Abishek, Yu, Jingyou, Liu, Jinyan, Peter, Lauren, McMahan, Katherine, Tostanoski, Lisa H., He, Xuan, Martinez, David R., Rutten, Lucy, Bos, Rinke, van Manen, Danielle, Vellinga, Jort, Custers, Jerome, Langedijk, Johannes P., Kwaks, Ted, Bakkers, Mark J. G., Zuijdgeest, David, Rosendahl Huber, Sietske K., Atyeo, Caroline, Fischinger, Stephanie, Burke, John S., Feldman, Jared, Hauser, Blake M., Caradonna, Timothy M., Bondzie, Esther A., Dagotto, Gabriel, Gebre, Makda S., Hoffman, Emily, Jacob-Dolan, Catherine, Kirilova, Marinela, Li, Zhenfeng, Lin, Zijin, Mahrokhian, Shant H., Maxfield, Lori F., Nampanya, Felix, Nityanandam, Ramya, Nkolola, Joseph P., Patel, Shivani, Ventura, John D., Verrington, Kaylee, Wan, Huahua, Pessaint, Laurent, Van Ry, Alex, Blade, Kelvin, Strasbaugh, Amanda, Cabus, Mehtap, Brown, Renita, Cook, Anthony, Zouantchangadou, Serge, Teow, Elyse, Andersen, Hanne, Lewis, Mark G., Cai, Yongfei, Chen, Bing, Schmidt, Aaron G., Reeves, R. Keith, Baric, Ralph S., Lauffenburger, Douglas A., Alter, Galit, Stoffels, Paul, Mammen, Mathai, Van Hoof, Johan, Schuitemaker, Hanneke, and Barouch, Dan H.

Published
2020
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6. Defining the determinants of protection against SARS-CoV-2 infection and viral control in a dose-down Ad26.CoV2.S vaccine study in nonhuman primates

Author

Massachusetts Institute of Technology. Department of Biological Engineering, Zhu, Daniel Y, Gorman, Matthew J, Yuan, Dansu, Yu, Jingyou, Mercado, Noe B, McMahan, Katherine, Borducchi, Erica N, Lifton, Michelle, Liu, Jinyan, Nampanya, Felix, Patel, Shivani, Peter, Lauren, Tostanoski, Lisa H, Pessaint, Laurent, Van Ry, Alex, Finneyfrock, Brad, Velasco, Jason, Teow, Elyse, Brown, Renita, Cook, Anthony, Andersen, Hanne, Lewis, Mark G, Lauffenburger, Douglas A, Barouch, Dan H, Alter, Galit, Massachusetts Institute of Technology. Department of Biological Engineering, Zhu, Daniel Y, Gorman, Matthew J, Yuan, Dansu, Yu, Jingyou, Mercado, Noe B, McMahan, Katherine, Borducchi, Erica N, Lifton, Michelle, Liu, Jinyan, Nampanya, Felix, Patel, Shivani, Peter, Lauren, Tostanoski, Lisa H, Pessaint, Laurent, Van Ry, Alex, Finneyfrock, Brad, Velasco, Jason, Teow, Elyse, Brown, Renita, Cook, Anthony, Andersen, Hanne, Lewis, Mark G, Lauffenburger, Douglas A, Barouch, Dan H, and Alter, Galit

Abstract

Despite the rapid creation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccines, the precise correlates of immunity against severe Coronavirus Disease 2019 (COVID-19) are still unknown. Neutralizing antibodies represent a robust surrogate of protection in early Phase III studies, but vaccines provide protection prior to the evolution of neutralization, vaccines provide protection against variants that evade neutralization, and vaccines continue to provide protection against disease severity in the setting of waning neutralizing titers. Thus, in this study, using an Ad26.CoV2.S dose-down approach in nonhuman primates (NHPs), the role of neutralization, Fc effector function, and T-cell immunity were collectively probed against infection as well as against viral control. While dosing-down minimally impacted neutralizing and binding antibody titers, Fc receptor binding and functional antibody levels were induced in a highly dose-dependent manner. Neutralizing antibody and Fc receptor binding titers, but minimally T cells, were linked to the prevention of transmission. Conversely, Fc receptor binding/function and T cells were linked to antiviral control, with a minimal role for neutralization. These data point to dichotomous roles of neutralization and T-cell function in protection against transmission and disease severity and a continuous role for Fc effector function as a correlate of immunity key to halting and controlling SARS-CoV-2 and emerging variants.

Published
2023

7. Publisher Correction: Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques

Author

Mercado, Noe B., Zahn, Roland, Wegmann, Frank, Loos, Carolin, Chandrashekar, Abishek, Yu, Jingyou, Liu, Jinyan, Peter, Lauren, McMahan, Katherine, Tostanoski, Lisa H., He, Xuan, Martinez, David R., Rutten, Lucy, Bos, Rinke, van Manen, Danielle, Vellinga, Jort, Custers, Jerome, Langedijk, Johannes P., Kwaks, Ted, Bakkers, Mark J. G., Zuijdgeest, David, Huber, Sietske K. Rosendahl, Atyeo, Caroline, Fischinger, Stephanie, Burke, John S., Feldman, Jared, Hauser, Blake M., Caradonna, Timothy M., Bondzie, Esther A., Dagotto, Gabriel, Gebre, Makda S., Hoffman, Emily, Jacob-Dolan, Catherine, Kirilova, Marinela, Li, Zhenfeng, Lin, Zijin, Mahrokhian, Shant H., Maxfield, Lori F., Nampanya, Felix, Nityanandam, Ramya, Nkolola, Joseph P., Patel, Shivani, Ventura, John D., Verrington, Kaylee, Wan, Huahua, Pessaint, Laurent, Van Ry, Alex, Blade, Kelvin, Strasbaugh, Amanda, Cabus, Mehtap, Brown, Renita, Cook, Anthony, Zouantchangadou, Serge, Teow, Elyse, Andersen, Hanne, Lewis, Mark G., Cai, Yongfei, Chen, Bing, Schmidt, Aaron G., Reeves, R. Keith, Baric, Ralph S., Lauffenburger, Douglas A., Alter, Galit, Stoffels, Paul, Mammen, Mathai, Van Hoof, Johan, Schuitemaker, Hanneke, and Barouch, Dan H.

Published
2021
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8. An intranasally administrated SARS-CoV-2 beta variant subunit booster vaccine prevents beta variant replication in rhesus macaques

Author

Sui, Yongjun, primary, Li, Jianping, additional, Andersen, Hanne, additional, Zhang, Roushu, additional, Prabhu, Sunaina K, additional, Hoang, Tanya, additional, Venzon, David, additional, Cook, Anthony, additional, Brown, Renita, additional, Teow, Elyse, additional, Velasco, Jason, additional, Pessaint, Laurent, additional, Moore, Ian N, additional, Lagenaur, Laurel, additional, Talton, Jim, additional, Breed, Matthew W, additional, Kramer, Josh, additional, Bock, Kevin W, additional, Minai, Mahnaz, additional, Nagata, Bianca M, additional, Choo-Wosoba, Hyoyoung, additional, Lewis, Mark G, additional, Wang, Lai-Xi, additional, and Berzofsky, Jay A, additional

Published
2022
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9. Defining the determinants of protection against SARS-CoV-2 infection and viral control in a dose-down Ad26.CoV2.S vaccine study in nonhuman primates

Author

Zhu, Daniel Y., primary, Gorman, Matthew J., additional, Yuan, Dansu, additional, Yu, Jingyou, additional, Mercado, Noe B., additional, McMahan, Katherine, additional, Borducchi, Erica N., additional, Lifton, Michelle, additional, Liu, Jinyan, additional, Nampanya, Felix, additional, Patel, Shivani, additional, Peter, Lauren, additional, Tostanoski, Lisa H., additional, Pessaint, Laurent, additional, Van Ry, Alex, additional, Finneyfrock, Brad, additional, Velasco, Jason, additional, Teow, Elyse, additional, Brown, Renita, additional, Cook, Anthony, additional, Andersen, Hanne, additional, Lewis, Mark G., additional, Lauffenburger, Douglas A., additional, Barouch, Dan H., additional, and Alter, Galit, additional

Published
2022
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10. SARS-CoV-2 receptor binding domain displayed on HBsAg virus–like particles elicits protective immunity in macaques

Author

Dalvie, Neil C., primary, Tostanoski, Lisa H., additional, Rodriguez-Aponte, Sergio A., additional, Kaur, Kawaljit, additional, Bajoria, Sakshi, additional, Kumru, Ozan S., additional, Martinot, Amanda J., additional, Chandrashekar, Abishek, additional, McMahan, Katherine, additional, Mercado, Noe B., additional, Yu, Jingyou, additional, Chang, Aiquan, additional, Giffin, Victoria M., additional, Nampanya, Felix, additional, Patel, Shivani, additional, Bowman, Lesley, additional, Naranjo, Christopher A., additional, Yun, Dongsoo, additional, Flinchbaugh, Zach, additional, Pessaint, Laurent, additional, Brown, Renita, additional, Velasco, Jason, additional, Teow, Elyse, additional, Cook, Anthony, additional, Andersen, Hanne, additional, Lewis, Mark G., additional, Camp, Danielle L., additional, Silverman, Judith Maxwell, additional, Nagar, Gaurav S., additional, Rao, Harish D., additional, Lothe, Rakesh R., additional, Chandrasekharan, Rahul, additional, Rajurkar, Meghraj P., additional, Shaligram, Umesh S., additional, Kleanthous, Harry, additional, Joshi, Sangeeta B., additional, Volkin, David B., additional, Biswas, Sumi, additional, Love, J. Christopher, additional, and Barouch, Dan H., additional

Published
2022
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11. Optimization of non-coding regions for a non-modified mRNA COVID-19 vaccine

Author

Gebre, Makda S., primary, Rauch, Susanne, additional, Roth, Nicole, additional, Yu, Jingyou, additional, Chandrashekar, Abishek, additional, Mercado, Noe B., additional, He, Xuan, additional, Liu, Jinyan, additional, McMahan, Katherine, additional, Martinot, Amanda, additional, Martinez, David R., additional, Giffin, Victoria, additional, Hope, David, additional, Patel, Shivani, additional, Sellers, Daniel, additional, Sanborn, Owen, additional, Barrett, Julia, additional, Liu, Xiaowen, additional, Cole, Andrew C., additional, Pessaint, Laurent, additional, Valentin, Daniel, additional, Flinchbaugh, Zack, additional, Yalley-Ogunro, Jake, additional, Muench, Jeanne, additional, Brown, Renita, additional, Cook, Anthony, additional, Teow, Elyse, additional, Andersen, Hanne, additional, Lewis, Mark G., additional, Boon, Adrianus C. M., additional, Baric, Ralph S., additional, Mueller, Stefan O., additional, Petsch, Benjamin, additional, and Barouch, Dan H., additional

Published
2021
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12. Prior infection with SARS-CoV-2 WA1/2020 partially protects rhesus macaques against reinfection with B.1.1.7 and B.1.351 variants

Author

Chandrashekar, Abishek, primary, Liu, Jinyan, additional, Yu, Jingyou, additional, McMahan, Katherine, additional, Tostanoski, Lisa H., additional, Jacob-Dolan, Catherine, additional, Mercado, Noe B., additional, Anioke, Tochi, additional, Chang, Aiquan, additional, Gardner, Sarah, additional, Giffin, Victoria M., additional, Hope, David L., additional, Nampanya, Felix, additional, Patel, Shivani, additional, Sanborn, Owen, additional, Sellers, Daniel, additional, Wan, Huahua, additional, Martinot, Amanda J., additional, Baczenas, John J., additional, O’Connor, Shelby L., additional, Pessaint, Laurent, additional, Valentin, Daniel, additional, Espina, Benjamin, additional, Wattay, Lauren, additional, Ferrari, Maria G., additional, Brown, Renita, additional, Cook, Anthony, additional, Bueno-Wilkerson, Deandre, additional, Teow, Elyse, additional, Andersen, Hanne, additional, Lewis, Mark G., additional, and Barouch, Dan H., additional

Published
2021
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13. An intranasally administrated SARS-CoV-2 beta variant subunit booster vaccine prevents beta variant viral replication in rhesus macaques

Author

Sui, Yongjun, primary, Li, Jianping, additional, Andersen, Hanne, additional, Zhang, Roushu, additional, Prabhu, Sunaina Kiran, additional, Hoang, Tanya, additional, Venzon, David, additional, Cook, Anthony, additional, Brown, Renita, additional, Teow, Elyse, additional, Velasco, Jason, additional, Pessaint, Laurent, additional, Moore, Ian N., additional, Lagenaur, Laurel, additional, Talton, Jim, additional, Breed, Matthew W., additional, Kramer, Josh, additional, Bock, Kevin W., additional, Minai, Mahnaz, additional, Nagata, Bianca M., additional, Choo-Wosoba, Hyoyoung, additional, Lewis, Mark G., additional, Wang, Lai-Xi, additional, and Berzofsky, Jay A., additional

Published
2021
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14. Optimization of Non-Coding Regions Improves Protective Efficacy of an mRNA SARS-CoV-2 Vaccine in Nonhuman Primates

Author

Gebre, Makda S., primary, Rauch, Susanne, additional, Roth, Nicole, additional, Yu, Jingyou, additional, Chandrashekar, Abishek, additional, Mercado, Noe B., additional, He, Xuan, additional, Liu, Jinyan, additional, McMahan, Katherine, additional, Martinot, Amanda, additional, Giffin, Tori, additional, Hope, David, additional, Patel, Shivani, additional, Sellers, Daniel, additional, Sanborn, Owen, additional, Barrett, Julia, additional, Liu, Xiaowen, additional, Cole, Andrew C., additional, Pessaint, Laurent, additional, Valentin, Daniel, additional, Flinchbaugh, Zack, additional, Yalley-Ogunro, Jake, additional, Muench, Jeanne, additional, Brown, Renita, additional, Cook, Anthony, additional, Teow, Elyse, additional, Andersen, Hanne, additional, Lewis, Mark G., additional, Mueller, Stefan O., additional, Petsch, Benjamin, additional, and Barouch, Dan H., additional

Published
2021
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15. A modular protein subunit vaccine candidate produced in yeast confers protection against SARS-CoV-2 in non-human primates

Author

Dalvie, Neil C., primary, Tostanoski, Lisa H., additional, Rodriguez-Aponte, Sergio A, additional, Kaur, Kawaljit, additional, Bajoria, Sakshi, additional, Kumru, Ozan S., additional, Martinot, Amanda J., additional, Chandrashekar, Abishek, additional, McMahan, Katherine, additional, Mercado, Noe B., additional, Yu, Jingyou, additional, Chang, Aiquan, additional, Giffin, Victoria M., additional, Nampanya, Felix, additional, Patel, Shivani, additional, Bowman, Lesley, additional, Naranjo, Christopher A., additional, Yun, Dongsoo, additional, Flinchbaugh, Zach, additional, Pessaint, Laurent, additional, Brown, Renita, additional, Velasco, Jason, additional, Teow, Elyse, additional, Cook, Anthony, additional, Andersen, Hanne, additional, Lewis, Mark G., additional, Camp, Danielle L., additional, Silverman, Judith Maxwell, additional, Kleanthous, Harry, additional, Joshi, Sangeeta B., additional, Volkin, David B., additional, Biswas, Sumi, additional, Love, J. Christopher, additional, and Barouch, Dan H., additional

Published
2021
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16. Low-dose Ad26.COV2.S protection against SARS-CoV-2 challenge in rhesus macaques

Author

He, Xuan, primary, Chandrashekar, Abishek, additional, Zahn, Roland, additional, Wegmann, Frank, additional, Yu, Jingyou, additional, Mercado, Noe B., additional, McMahan, Katherine, additional, Martinot, Amanda J., additional, Piedra-Mora, Cesar, additional, Beecy, Sidney, additional, Ducat, Sarah, additional, Chamanza, Ronnie, additional, Huber, Sietske Rosendahl, additional, van Heerden, Marjolein, additional, van der Fits, Leslie, additional, Borducchi, Erica N., additional, Lifton, Michelle, additional, Liu, Jinyan, additional, Nampanya, Felix, additional, Patel, Shivani, additional, Peter, Lauren, additional, Tostanoski, Lisa H., additional, Pessaint, Laurent, additional, Van Ry, Alex, additional, Finneyfrock, Brad, additional, Velasco, Jason, additional, Teow, Elyse, additional, Brown, Renita, additional, Cook, Anthony, additional, Andersen, Hanne, additional, Lewis, Mark G., additional, Schuitemaker, Hanneke, additional, and Barouch, Dan H., additional

Published
2021
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17. Correlates of protection against SARS-CoV-2 in rhesus macaques

Author

Ragon Institute of MGH, MIT and Harvard, Massachusetts Institute of Technology. Department of Biological Engineering, McMahan, Katherine, Yu, Jingyou, Mercado, Noe B., Loos, Carolin, Tostanoski, Lisa H., Chandrashekar, Abishek, Liu, Jinyan, Peter, Lauren, Atyeo, Caroline, Zhu, Alex Lee, Bondzie, Esther A., Dagotto, Gabriel, Gebre, Makda S., Jacob-Dolan, Catherine, Li, Zhenfeng, Nampanya, Felix, Patel, Shivani, Pessaint, Laurent, Van Ry, Alex, Blade, Kelvin, Yalley-Ogunro, Jake, Cabus, Mehtap, Brown, Renita, Cook, Anthony, Teow, Elyse, Andersen, Hanne, Lewis, Mark G., Lauffenburger, Douglas A, Alter, Galit, Barouch, Dan H., Ragon Institute of MGH, MIT and Harvard, Massachusetts Institute of Technology. Department of Biological Engineering, McMahan, Katherine, Yu, Jingyou, Mercado, Noe B., Loos, Carolin, Tostanoski, Lisa H., Chandrashekar, Abishek, Liu, Jinyan, Peter, Lauren, Atyeo, Caroline, Zhu, Alex Lee, Bondzie, Esther A., Dagotto, Gabriel, Gebre, Makda S., Jacob-Dolan, Catherine, Li, Zhenfeng, Nampanya, Felix, Patel, Shivani, Pessaint, Laurent, Van Ry, Alex, Blade, Kelvin, Yalley-Ogunro, Jake, Cabus, Mehtap, Brown, Renita, Cook, Anthony, Teow, Elyse, Andersen, Hanne, Lewis, Mark G., Lauffenburger, Douglas A, Alter, Galit, and Barouch, Dan H.

Abstract

Recent studies have reported the protective efficacy of both natural1 and vaccine-induced2–7 immunity against challenge with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in rhesus macaques. However, the importance of humoral and cellular immunity for protection against infection with SARS-CoV-2 remains to be determined. Here we show that the adoptive transfer of purified IgG from convalescent rhesus macaques (Macaca mulatta) protects naive recipient macaques against challenge with SARS-CoV-2 in a dose-dependent fashion. Depletion of CD8+ T cells in convalescent macaques partially abrogated the protective efficacy of natural immunity against rechallenge with SARS-CoV-2, which suggests a role for cellular immunity in the context of waning or subprotective antibody titres. These data demonstrate that relatively low antibody titres are sufficient for protection against SARS-CoV-2 in rhesus macaques, and that cellular immune responses may contribute to protection if antibody responses are suboptimal. We also show that higher antibody titres are required for treatment of SARS-CoV-2 infection in macaques. These findings have implications for the development of SARS-CoV-2 vaccines and immune-based therapeutic agents., Bill & Melinda Gates Foundation (Grant INV-006131), National Institutes of Health (Grants OD024917, AI129797, AI124377, AI128751, AI126603 and CA260476)

Published
2021

18. Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques

Author

Ragon Institute of MGH, MIT and Harvard, Massachusetts Institute of Technology. Department of Biological Engineering, Mercado, Noe B., Zahn, Roland, Wegmann, Frank, Loos, Carolin, Chandrashekar, Abishek, Yu, Jingyou, Liu, Jinyan, Peter, Lauren, McMahan, Katherine, Tostanoski, Lisa H., He, Xuan, Martinez, David R., Rutten, Lucy, Bos, Rinke, van Manen, Danielle, Vellinga, Jort, Custers, Jerome, Langedijk, Johannes P., Kwaks, Ted, Bakkers, Mark J. G., Zuijdgeest, David, Rosendahl Huber, Sietske K., Atyeo, Caroline, Fischinger, Stephanie, Burke, John, Feldman, Jared, Hauser, Blake Marie, Caradonna, Timothy M., Bondzie, Esther A., Dagotto, Gabriel, Gebre, Makda S., Hoffman, Emily, Jacob-Dolan, Catherine, Kirilova, Marinela, Li, Zhenfeng, Lin, Zijin, Mahrokhian, Shant H., Maxfield, Lori F., Nampanya, Felix, Nityanandam, Ramya, Nkolola, Joseph P., Patel, Shivani, Ventura, John D., Verrington, Kaylee, Wan, Huahua, Pessaint, Laurent, Van Ry, Alex, Blade, Kelvin, Strasbaugh, Amanda, Cabus, Mehtap, Brown, Renita, Cook, Anthony, Zouantchangadou, Serge, Teow, Elyse, Andersen, Hanne, Lewis, Mark G., Cai, Yongfei, Chen, Bing, Schmidt, Aaron G., Reeves, R. Keith, Baric, Ralph S., Lauffenburger, Douglas A., Alter, Galit, Stoffels, Paul, Mammen, Mathai, Van Hoof, Johan, Schuitemaker, Hanneke, Barouch, Dan, Ragon Institute of MGH, MIT and Harvard, Massachusetts Institute of Technology. Department of Biological Engineering, Mercado, Noe B., Zahn, Roland, Wegmann, Frank, Loos, Carolin, Chandrashekar, Abishek, Yu, Jingyou, Liu, Jinyan, Peter, Lauren, McMahan, Katherine, Tostanoski, Lisa H., He, Xuan, Martinez, David R., Rutten, Lucy, Bos, Rinke, van Manen, Danielle, Vellinga, Jort, Custers, Jerome, Langedijk, Johannes P., Kwaks, Ted, Bakkers, Mark J. G., Zuijdgeest, David, Rosendahl Huber, Sietske K., Atyeo, Caroline, Fischinger, Stephanie, Burke, John, Feldman, Jared, Hauser, Blake Marie, Caradonna, Timothy M., Bondzie, Esther A., Dagotto, Gabriel, Gebre, Makda S., Hoffman, Emily, Jacob-Dolan, Catherine, Kirilova, Marinela, Li, Zhenfeng, Lin, Zijin, Mahrokhian, Shant H., Maxfield, Lori F., Nampanya, Felix, Nityanandam, Ramya, Nkolola, Joseph P., Patel, Shivani, Ventura, John D., Verrington, Kaylee, Wan, Huahua, Pessaint, Laurent, Van Ry, Alex, Blade, Kelvin, Strasbaugh, Amanda, Cabus, Mehtap, Brown, Renita, Cook, Anthony, Zouantchangadou, Serge, Teow, Elyse, Andersen, Hanne, Lewis, Mark G., Cai, Yongfei, Chen, Bing, Schmidt, Aaron G., Reeves, R. Keith, Baric, Ralph S., Lauffenburger, Douglas A., Alter, Galit, Stoffels, Paul, Mammen, Mathai, Van Hoof, Johan, Schuitemaker, Hanneke, and Barouch, Dan

Abstract

A safe and effective vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may be required to end the coronavirus disease 2019 (COVID-19) pandemic1–8. For global deployment and pandemic control, a vaccine that requires only a single immunization would be optimal. Here we show the immunogenicity and protective efficacy of a single dose of adenovirus serotype 26 (Ad26) vector-based vaccines expressing the SARS-CoV-2 spike (S) protein in non-human primates. Fifty-two rhesus macaques (Macaca mulatta) were immunized with Ad26 vectors that encoded S variants or sham control, and then challenged with SARS-CoV-2 by the intranasal and intratracheal routes9,10. The optimal Ad26 vaccine induced robust neutralizing antibody responses and provided complete or near-complete protection in bronchoalveolar lavage and nasal swabs after SARS-CoV-2 challenge. Titres of vaccine-elicited neutralizing antibodies correlated with protective efficacy, suggesting an immune correlate of protection. These data demonstrate robust single-shot vaccine protection against SARS-CoV-2 in non-human primates. The optimal Ad26 vector-based vaccine for SARS-CoV-2, termed Ad26.COV2.S, is currently being evaluated in clinical trials.

Published
2021

19. Protection against SARS-CoV-2 infection by a mucosal vaccine in rhesus macaques

Author

Sui, Yongjun, primary, Li, Jianping, additional, Zhang, Roushu, additional, Prabhu, Sunaina Kiran, additional, Andersen, Hanne, additional, Venzon, David, additional, Cook, Anthony, additional, Brown, Renita, additional, Teow, Elyse, additional, Velasco, Jason, additional, Greenhouse, Jack, additional, Putman-Taylor, Tammy, additional, Campbell, Tracey-Ann, additional, Pessaint, Laurent, additional, Moore, Ian N., additional, Lagenaur, Laurel, additional, Talton, Jim, additional, Breed, Matthew W., additional, Kramer, Josh, additional, Bock, Kevin W., additional, Minai, Mahnaz, additional, Nagata, Bianca M., additional, Lewis, Mark G., additional, Wang, Lai-Xi, additional, and Berzofsky, Jay A., additional

Published
2021
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20. Correlates of protection against SARS-CoV-2 in rhesus macaques

Author

McMahan, Katherine, primary, Yu, Jingyou, additional, Mercado, Noe B., additional, Loos, Carolin, additional, Tostanoski, Lisa H., additional, Chandrashekar, Abishek, additional, Liu, Jinyan, additional, Peter, Lauren, additional, Atyeo, Caroline, additional, Zhu, Alex, additional, Bondzie, Esther A., additional, Dagotto, Gabriel, additional, Gebre, Makda S., additional, Jacob-Dolan, Catherine, additional, Li, Zhenfeng, additional, Nampanya, Felix, additional, Patel, Shivani, additional, Pessaint, Laurent, additional, Van Ry, Alex, additional, Blade, Kelvin, additional, Yalley-Ogunro, Jake, additional, Cabus, Mehtap, additional, Brown, Renita, additional, Cook, Anthony, additional, Teow, Elyse, additional, Andersen, Hanne, additional, Lewis, Mark G., additional, Lauffenburger, Douglas A., additional, Alter, Galit, additional, and Barouch, Dan H., additional

Published
2020
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21. REGN-COV2 antibodies prevent and treat SARS-CoV-2 infection in rhesus macaques and hamsters

Author

Baum, Alina, primary, Ajithdoss, Dharani, additional, Copin, Richard, additional, Zhou, Anbo, additional, Lanza, Kathryn, additional, Negron, Nicole, additional, Ni, Min, additional, Wei, Yi, additional, Mohammadi, Kusha, additional, Musser, Bret, additional, Atwal, Gurinder S., additional, Oyejide, Adelekan, additional, Goez-Gazi, Yenny, additional, Dutton, John, additional, Clemmons, Elizabeth, additional, Staples, Hilary M., additional, Bartley, Carmen, additional, Klaffke, Benjamin, additional, Alfson, Kendra, additional, Gazi, Michal, additional, Gonzalez, Olga, additional, Dick, Edward, additional, Carrion, Ricardo, additional, Pessaint, Laurent, additional, Porto, Maciel, additional, Cook, Anthony, additional, Brown, Renita, additional, Ali, Vaneesha, additional, Greenhouse, Jack, additional, Taylor, Tammy, additional, Andersen, Hanne, additional, Lewis, Mark G., additional, Stahl, Neil, additional, Murphy, Andrew J., additional, Yancopoulos, George D., additional, and Kyratsous, Christos A., additional

Published
2020
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22. REGN-COV2 antibody cocktail prevents and treats SARS-CoV-2 infection in rhesus macaques and hamsters

Author

Baum, Alina, primary, Copin, Richard, additional, Ajithdoss, Dharani, additional, Zhou, Anbo, additional, Lanza, Kathryn, additional, Negron, Nicole, additional, Ni, Min, additional, Wei, Yi, additional, Atwal, Gurinder S., additional, Oyejide, Adelekan, additional, Goez-Gazi, Yenny, additional, Dutton, John, additional, Clemmons, Elizabeth, additional, Staples, Hilary M., additional, Bartley, Carmen, additional, Klaffke, Benjamin, additional, Alfson, Kendra, additional, Gazi, Michal, additional, Gonzales, Olga, additional, Dick, Edward, additional, Carrion, Ricardo, additional, Pessaint, Laurent, additional, Porto, Maciel, additional, Cook, Anthony, additional, Brown, Renita, additional, Ali, Vaneesha, additional, Greenhouse, Jack, additional, Taylor, Tammy, additional, Andersen, Hanne, additional, Lewis, Mark G., additional, Stahl, Neil, additional, Murphy, Andrew J., additional, Yancopoulos, George D., additional, and Kyratsous, Christos A., additional

Published
2020
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23. DNA vaccine protection against SARS-CoV-2 in rhesus macaques

Author

Yu, Jingyou, primary, Tostanoski, Lisa H., additional, Peter, Lauren, additional, Mercado, Noe B., additional, McMahan, Katherine, additional, Mahrokhian, Shant H., additional, Nkolola, Joseph P., additional, Liu, Jinyan, additional, Li, Zhenfeng, additional, Chandrashekar, Abishek, additional, Martinez, David R., additional, Loos, Carolin, additional, Atyeo, Caroline, additional, Fischinger, Stephanie, additional, Burke, John S., additional, Slein, Matthew D., additional, Chen, Yuezhou, additional, Zuiani, Adam, additional, Lelis, Felipe J. N., additional, Travers, Meghan, additional, Habibi, Shaghayegh, additional, Pessaint, Laurent, additional, Van Ry, Alex, additional, Blade, Kelvin, additional, Brown, Renita, additional, Cook, Anthony, additional, Finneyfrock, Brad, additional, Dodson, Alan, additional, Teow, Elyse, additional, Velasco, Jason, additional, Zahn, Roland, additional, Wegmann, Frank, additional, Bondzie, Esther A., additional, Dagotto, Gabriel, additional, Gebre, Makda S., additional, He, Xuan, additional, Jacob-Dolan, Catherine, additional, Kirilova, Marinela, additional, Kordana, Nicole, additional, Lin, Zijin, additional, Maxfield, Lori F., additional, Nampanya, Felix, additional, Nityanandam, Ramya, additional, Ventura, John D., additional, Wan, Huahua, additional, Cai, Yongfei, additional, Chen, Bing, additional, Schmidt, Aaron G., additional, Wesemann, Duane R., additional, Baric, Ralph S., additional, Alter, Galit, additional, Andersen, Hanne, additional, Lewis, Mark G., additional, and Barouch, Dan H., additional

Published
2020
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24. SARS-CoV-2 infection protects against rechallenge in rhesus macaques

Author

Chandrashekar, Abishek, primary, Liu, Jinyan, additional, Martinot, Amanda J., additional, McMahan, Katherine, additional, Mercado, Noe B., additional, Peter, Lauren, additional, Tostanoski, Lisa H., additional, Yu, Jingyou, additional, Maliga, Zoltan, additional, Nekorchuk, Michael, additional, Busman-Sahay, Kathleen, additional, Terry, Margaret, additional, Wrijil, Linda M., additional, Ducat, Sarah, additional, Martinez, David R., additional, Atyeo, Caroline, additional, Fischinger, Stephanie, additional, Burke, John S., additional, Slein, Matthew D., additional, Pessaint, Laurent, additional, Van Ry, Alex, additional, Greenhouse, Jack, additional, Taylor, Tammy, additional, Blade, Kelvin, additional, Cook, Anthony, additional, Finneyfrock, Brad, additional, Brown, Renita, additional, Teow, Elyse, additional, Velasco, Jason, additional, Zahn, Roland, additional, Wegmann, Frank, additional, Abbink, Peter, additional, Bondzie, Esther A., additional, Dagotto, Gabriel, additional, Gebre, Makda S., additional, He, Xuan, additional, Jacob-Dolan, Catherine, additional, Kordana, Nicole, additional, Li, Zhenfeng, additional, Lifton, Michelle A., additional, Mahrokhian, Shant H., additional, Maxfield, Lori F., additional, Nityanandam, Ramya, additional, Nkolola, Joseph P., additional, Schmidt, Aaron G., additional, Miller, Andrew D., additional, Baric, Ralph S., additional, Alter, Galit, additional, Sorger, Peter K., additional, Estes, Jacob D., additional, Andersen, Hanne, additional, Lewis, Mark G., additional, and Barouch, Dan H., additional

Published
2020
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25. A modular protein subunit vaccine candidate produced in yeast confers protection against SARS-CoV-2 in non-human primates.

Author

Dalvie NC, Tostanoski LH, Rodriguez-Aponte SA, Kaur K, Bajoria S, Kumru OS, Martinot AJ, Chandrashekar A, McMahan K, Mercado NB, Yu J, Chang A, Giffin VM, Nampanya F, Patel S, Bowman L, Naranjo CA, Yun D, Flinchbaugh Z, Pessaint L, Brown R, Velasco J, Teow E, Cook A, Andersen H, Lewis MG, Camp DL, Silverman JM, Kleanthous H, Joshi SB, Volkin DB, Biswas S, Love JC, and Barouch DH

Abstract

Vaccines against SARS-CoV-2 have been distributed at massive scale in developed countries, and have been effective at preventing COVID-19. Access to vaccines is limited, however, in low- and middle-income countries (LMICs) due to insufficient supply, high costs, and cold storage requirements. New vaccines that can be produced in existing manufacturing facilities in LMICs, can be manufactured at low cost, and use widely available, proven, safe adjuvants like alum, would improve global immunity against SARS-CoV-2. One such protein subunit vaccine is produced by the Serum Institute of India Pvt. Ltd. and is currently in clinical testing. Two protein components, the SARS-CoV-2 receptor binding domain (RBD) and hepatitis B surface antigen virus-like particles (VLPs), are each produced in yeast, which would enable a low-cost, high-volume manufacturing process. Here, we describe the design and preclinical testing of the RBD-VLP vaccine in cynomolgus macaques. We observed titers of neutralizing antibodies (>10 4 ) above the range of protection for other licensed vaccines in non-human primates. Interestingly, addition of a second adjuvant (CpG1018) appeared to improve the cellular response while reducing the humoral response. We challenged animals with SARS-CoV-2, and observed a ~3.4 and ~2.9 log 10 reduction in median viral loads in bronchoalveolar lavage and nasal mucosa, respectively, compared to sham controls. These results inform the design and formulation of current clinical COVID-19 vaccine candidates like the one described here, and future designs of RBD-based vaccines against variants of SARS-CoV-2 or other betacoronaviruses., Competing Interests: Competing interests J.C.L. has interests in Sunflower Therapeutics PBC, Pfizer, Honeycomb Biotechnologies, OneCyte Biotechnologies, QuantumCyte, Amgen, and Repligen. J.C.L’s interests are reviewed and managed under MIT’s policies for potential conflicts of interest. J.M.S. is an employee of the Bill & Melinda Gates Medical Research Institute. H.K. is an employee of the Bill & Melinda Gates Foundation. Sumi Biswas is the CEO and co-founder of SpyBiotech Ltd. which holds the exclusive rights for the use of Spytag/Spyctacher in the field of vaccines. Lesley Bowman is an employee of SpyBiotech Ltd.

Published
2021
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26. Low-Dose Ad26.COV2.S Protection Against SARS-CoV-2 Challenge in Rhesus Macaques.

Author

He X, Chandrashekar A, Zahn R, Wegmann F, Yu J, Mercado NB, McMahan K, Martinot AJ, Piedra-Mora C, Beecy S, Ducat S, Chamanza R, Huber SR, van der Fits L, Borducchi EN, Lifton M, Liu J, Nampanya F, Patel S, Peter L, Tostanoski LH, Pessaint L, Van Ry A, Finneyfrock B, Velasco J, Teow E, Brown R, Cook A, Andersen H, Lewis MG, Schuitemaker H, and Barouch DH

Abstract

We previously reported that a single immunization with an adenovirus serotype 26 (Ad26) vector-based vaccine expressing an optimized SARS-CoV-2 spike (Ad26.COV2.S) protected rhesus macaques against SARS-CoV-2 challenge. In this study, we evaluated the immunogenicity and protective efficacy of reduced doses of Ad26.COV2.S. 30 rhesus macaques were immunized once with 1×10 11 , 5×10 10 , 1.125×10 10 , or 2×10 9 vp Ad26.COV2.S or sham and were challenged with SARS-CoV-2 by the intranasal and intratracheal routes. Vaccine doses as low as 2×10 9 vp provided robust protection in bronchoalveolar lavage, whereas doses of 1.125×10 10 vp were required for protection in nasal swabs. Activated memory B cells as well as binding and neutralizing antibody titers following vaccination correlated with protective efficacy. At suboptimal vaccine doses, viral breakthrough was observed but did not show evidence of virologic, immunologic, histopathologic, or clinical enhancement of disease compared with sham controls. These data demonstrate that a single immunization with a relatively low dose of Ad26.COV2.S effectively protected against SARS-CoV-2 challenge in rhesus macaques. Moreover, our findings show that a higher vaccine dose may be required for protection in the upper respiratory tract compared with the lower respiratory tract.

Published
2021
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