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1. Mucosal adenovirus vaccine boosting elicits IgA and durably prevents XBB.1.16 infection in nonhuman primates

Author

Gagne, Matthew, Flynn, Barbara J., Andrew, Shayne F., Marquez, Josue, Flebbe, Dillon R., Mychalowych, Anna, Lamb, Evan, Davis-Gardner, Meredith E., Burnett, Matthew R., Serebryannyy, Leonid A., Lin, Bob C., Ziff, Zohar E., Maule, Erin, Carroll, Robin, Naisan, Mursal, Jethmalani, Yogita, Pessaint, Laurent, Todd, John-Paul M., Doria-Rose, Nicole A., Case, James Brett, Dmitriev, Igor P., Kashentseva, Elena A., Ying, Baoling, Dodson, Alan, Kouneski, Katelyn, O’Dell, Sijy, Wali, Bushra, Ellis, Madison, Godbole, Sucheta, Laboune, Farida, Henry, Amy R., Teng, I-Ting, Wang, Danyi, Wang, Lingshu, Zhou, Qiong, Zouantchangadou, Serge, Van Ry, Alex, Lewis, Mark G., Andersen, Hanne, Kwong, Peter D., Curiel, David T., Roederer, Mario, Nason, Martha C., Foulds, Kathryn E., Suthar, Mehul S., Diamond, Michael S., Douek, Daniel C., and Seder, Robert A.

Published
2024
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2. Variant-proof high affinity ACE2 antagonist limits SARS-CoV-2 replication in upper and lower airways

Author

Gagne, Matthew, Flynn, Barbara J., Honeycutt, Christopher Cole, Flebbe, Dillon R., Andrew, Shayne F., Provost, Samantha J., McCormick, Lauren, Van Ry, Alex, McCarthy, Elizabeth, Todd, John-Paul M., Bao, Saran, Teng, I-Ting, Marciano, Shir, Rudich, Yinon, Li, Chunlin, Jain, Shilpi, Wali, Bushra, Pessaint, Laurent, Dodson, Alan, Cook, Anthony, Lewis, Mark G., Andersen, Hanne, Zahradník, Jiří, Suthar, Mehul S., Nason, Martha C., Foulds, Kathryn E., Kwong, Peter D., Roederer, Mario, Schreiber, Gideon, Seder, Robert A., and Douek, Daniel C.

Published
2024
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3. mRNA-1273 or mRNA-Omicron boost in vaccinated macaques elicits similar B cell expansion, neutralizing responses, and protection from Omicron

Author

Gagne, Matthew, Moliva, Juan I., Foulds, Kathryn E., Andrew, Shayne F., Flynn, Barbara J., Werner, Anne P., Wagner, Danielle A., Teng, I-Ting, Lin, Bob C., Moore, Christopher, Jean-Baptiste, Nazaire, Carroll, Robin, Foster, Stephanie L., Patel, Mit, Ellis, Madison, Edara, Venkata-Viswanadh, Maldonado, Nahara Vargas, Minai, Mahnaz, McCormick, Lauren, Honeycutt, Christopher Cole, Nagata, Bianca M., Bock, Kevin W., Dulan, Caitlyn N.M., Cordon, Jamilet, Flebbe, Dillon R., Todd, John-Paul M., McCarthy, Elizabeth, Pessaint, Laurent, Van Ry, Alex, Narvaez, Brandon, Valentin, Daniel, Cook, Anthony, Dodson, Alan, Steingrebe, Katelyn, Nurmukhambetova, Saule T., Godbole, Sucheta, Henry, Amy R., Laboune, Farida, Roberts-Torres, Jesmine, Lorang, Cynthia G., Amin, Shivani, Trost, Jessica, Naisan, Mursal, Basappa, Manjula, Willis, Jacquelyn, Wang, Lingshu, Shi, Wei, Doria-Rose, Nicole A., Zhang, Yi, Yang, Eun Sung, Leung, Kwanyee, O’Dell, Sijy, Schmidt, Stephen D., Olia, Adam S., Liu, Cuiping, Harris, Darcy R., Chuang, Gwo-Yu, Stewart-Jones, Guillaume, Renzi, Isabella, Lai, Yen-Ting, Malinowski, Agata, Wu, Kai, Mascola, John R., Carfi, Andrea, Kwong, Peter D., Edwards, Darin K., Lewis, Mark G., Andersen, Hanne, Corbett, Kizzmekia S., Nason, Martha C., McDermott, Adrian B., Suthar, Mehul S., Moore, Ian N., Roederer, Mario, Sullivan, Nancy J., Douek, Daniel C., and Seder, Robert A.

Published
2022
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4. Protection from SARS-CoV-2 Delta one year after mRNA-1273 vaccination in rhesus macaques coincides with anamnestic antibody response in the lung

Author

Gagne, Matthew, Corbett, Kizzmekia S., Flynn, Barbara J., Foulds, Kathryn E., Wagner, Danielle A., Andrew, Shayne F., Todd, John-Paul M., Honeycutt, Christopher Cole, McCormick, Lauren, Nurmukhambetova, Saule T., Davis-Gardner, Meredith E., Pessaint, Laurent, Bock, Kevin W., Nagata, Bianca M., Minai, Mahnaz, Werner, Anne P., Moliva, Juan I., Tucker, Courtney, Lorang, Cynthia G., Zhao, Bingchun, McCarthy, Elizabeth, Cook, Anthony, Dodson, Alan, Teng, I-Ting, Mudvari, Prakriti, Roberts-Torres, Jesmine, Laboune, Farida, Wang, Lingshu, Goode, Adrienne, Kar, Swagata, Boyoglu-Barnum, Seyhan, Yang, Eun Sung, Shi, Wei, Ploquin, Aurélie, Doria-Rose, Nicole, Carfi, Andrea, Mascola, John R., Boritz, Eli A., Edwards, Darin K., Andersen, Hanne, Lewis, Mark G., Suthar, Mehul S., Graham, Barney S., Roederer, Mario, Moore, Ian N., Nason, Martha C., Sullivan, Nancy J., Douek, Daniel C., and Seder, Robert A.

Published
2022
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5. mRNA-1273 protects against SARS-CoV-2 beta infection in nonhuman primates

Author

Corbett, Kizzmekia S., Werner, Anne P., Connell, Sarah O’, Gagne, Matthew, Lai, Lilin, Moliva, Juan I., Flynn, Barbara, Choi, Angela, Koch, Matthew, Foulds, Kathryn E., Andrew, Shayne F., Flebbe, Dillon R., Lamb, Evan, Nurmukhambetova, Saule T., Provost, Samantha J., Bock, Kevin W., Minai, Mahnaz, Nagata, Bianca M., Ry, Alex Van, Flinchbaugh, Zackery, Johnston, Timothy S., Mokhtari, Elham Bayat, Mudvari, Prakriti, Henry, Amy R., Laboune, Farida, Chang, Becky, Porto, Maciel, Wear, Jaclyn, Alvarado, Gabriela S., Boyoglu-Barnum, Seyhan, Todd, John-Paul M., Bart, Bridget, Cook, Anthony, Dodson, Alan, Pessaint, Laurent, Steingrebe, Katelyn, Elbashir, Sayda, Sriparna, Manjari, Pekosz, Andrew, Andersen, Hanne, Wu, Kai, Edwards, Darin K., Kar, Swagata, Lewis, Mark G., Boritz, Eli, Moore, Ian N., Carfi, Andrea, Suthar, Mehul S., McDermott, Adrian, Roederer, Mario, Nason, Martha C., Sullivan, Nancy J., Douek, Daniel C., Graham, Barney S., and Seder, Robert A.

Published
2021
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7. Durable immunity to SARS-CoV-2 in both lower and upper airways achieved with a gorilla adenovirus (GRAd) S-2P vaccine in non-human primates

Author

Moliva, Juan I, primary, Andrew, Shayne F, additional, Flynn, Barbara J, additional, Wagner, Danielle A, additional, Foulds, Kathryn E, additional, Gagne, Matthew, additional, Flebbe, Dillon R, additional, Lamb, Evan, additional, Provost, Samantha, additional, Marquez, Josue, additional, Mychalowych, Anna, additional, Lorag, Cynthia, additional, Honeycutt, Christopher Cole, additional, Burnett, Matthew R, additional, McCormick, Lauren, additional, Henry, Amy R, additional, Godbole, Sucheta, additional, Davis-Gardner, Meredith E, additional, Minai, Mahnaz, additional, Bok, Kevin W, additional, Nagata, Bianca M, additional, Todd, John-Paul M, additional, McCarthy, Elizabeth, additional, Dodson, Alan, additional, Kouneski, Katelyn, additional, Cook, Anthony, additional, Pessaint, Laurent, additional, Van Ry, Alex, additional, Valentin, Daniel, additional, Young, Steve, additional, Littman, Yoav, additional, Boon, Adrianus C. M., additional, Suthar, Mehul S, additional, Lewis, Mark G, additional, Andersen, Hanne, additional, Alves, Derron A, additional, Woodward, Ruth, additional, Leuzzi, Adriano, additional, Vitelli, Alessandra, additional, Colloca, Stefano, additional, Folgori, Antonella, additional, Raggiolli, Angelo, additional, Capone, Stefania, additional, Nason, Martha C, additional, Douek, Daniel, additional, Roederer, Mario, additional, Seder, Robert A, additional, and Sullivan, Nancy J, additional

Published
2023
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8. Mucosal Adenoviral-vectored Vaccine Boosting Durably Prevents XBB.1.16 Infection in Nonhuman Primates

Author

Gagne, Matthew, primary, Flynn, Barbara J., additional, Andrew, Shayne F., additional, Flebbe, Dillon R., additional, Mychalowych, Anna, additional, Lamb, Evan, additional, Davis-Gardner, Meredith E., additional, Burnett, Matthew R., additional, Serebryannyy, Leonid A., additional, Lin, Bob C., additional, Pessaint, Laurent, additional, Todd, John-Paul M., additional, Ziff, Zohar E., additional, Maule, Erin, additional, Carroll, Robin, additional, Naisan, Mursal, additional, Jethmalani, Yogita, additional, Case, James Brett, additional, Dmitriev, Igor P., additional, Kashentseva, Elena A., additional, Ying, Baoling, additional, Dodson, Alan, additional, Kouneski, Katelyn, additional, Doria-Rose, Nicole A., additional, O'Dell, Sijy, additional, Godbole, Sucheta, additional, Laboune, Farida, additional, Henry, Amy R., additional, Marquez, Josue, additional, Teng, I-Ting, additional, Wang, Lingshu, additional, Zhou, Qiong, additional, Wali, Bushra, additional, Ellis, Madison, additional, Zouantchangadou, Serge, additional, Van Ry, Alex, additional, Lewis, Mark G., additional, Andersen, Hanne, additional, Kwong, Peter D., additional, Curiel, David T., additional, Foulds, Kathryn E., additional, Nason, Martha C., additional, Suthar, Mehul S., additional, Roederer, Mario, additional, Diamond, Michael S., additional, Douek, Daniel C., additional, and Seder, Robert A., additional

Published
2023
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9. RBD-based high affinity ACE2 antagonist limits SARS-CoV-2 replication in upper and lower airways

Author

Gagne, Matthew, primary, Flynn, Barbara J., additional, Honeycutt, Christopher Cole, additional, Flebbe, Dillon R., additional, Andrew, Shayne F., additional, Provost, Samantha J., additional, McCormick, Lauren, additional, Van Ry, Alex, additional, McCarthy, Elizabeth, additional, Todd, John-Paul M., additional, Bao, Saran, additional, Teng, I-Ting, additional, Marciano, Shir, additional, Rudich, Yinon, additional, Li, Chunlin, additional, Pessaint, Laurent, additional, Dodson, Alan, additional, Cook, Anthony, additional, Lewis, Mark G., additional, Andersen, Hanne, additional, Zahradník, Jiří, additional, Nason, Martha C., additional, Foulds, Kathryn E., additional, Kwong, Peter D., additional, Roederer, Mario, additional, Schreiber, Gideon, additional, Seder, Robert A., additional, and Douek, Daniel C., additional

Published
2023
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11. mRNA-1273 or mRNA-Omicron boost in vaccinated macaques elicits comparable B cell expansion, neutralizing antibodies and protection against Omicron

Author

Gagne, Matthew, primary, Moliva, Juan I., additional, Foulds, Kathryn E., additional, Andrew, Shayne F., additional, Flynn, Barbara J., additional, Werner, Anne P., additional, Wagner, Danielle A., additional, Teng, I-Ting, additional, Lin, Bob C., additional, Moore, Christopher, additional, Jean-Baptiste, Nazaire, additional, Carroll, Robin, additional, Foster, Stephanie L., additional, Patel, Mit, additional, Ellis, Madison, additional, Edara, Venkata-Viswanadh, additional, Maldonado, Nahara Vargas, additional, Minai, Mahnaz, additional, McCormick, Lauren, additional, Honeycutt, Christopher Cole, additional, Nagata, Bianca M., additional, Bock, Kevin W., additional, Dulan, Caitlyn N. M., additional, Cordon, Jamilet, additional, Todd, John-Paul M., additional, McCarthy, Elizabeth, additional, Pessaint, Laurent, additional, Van Ry, Alex, additional, Narvaez, Brandon, additional, Valentin, Daniel, additional, Cook, Anthony, additional, Dodson, Alan, additional, Steingrebe, Katelyn, additional, Flebbe, Dillon R., additional, Nurmukhambetova, Saule T., additional, Godbole, Sucheta, additional, Henry, Amy R., additional, Laboune, Farida, additional, Roberts-Torres, Jesmine, additional, Lorang, Cynthia G., additional, Amin, Shivani, additional, Trost, Jessica, additional, Naisan, Mursal, additional, Basappa, Manjula, additional, Willis, Jacquelyn, additional, Wang, Lingshu, additional, Shi, Wei, additional, Doria-Rose, Nicole A., additional, Olia, Adam S., additional, Liu, Cuiping, additional, Harris, Darcy R., additional, Carfi, Andrea, additional, Mascola, John R., additional, Kwong, Peter D., additional, Edwards, Darin K., additional, Andersen, Hanne, additional, Lewis, Mark G., additional, Corbett, Kizzmekia S., additional, Nason, Martha C., additional, McDermott, Adrian B., additional, Suthar, Mehul S., additional, Moore, Ian N., additional, Roederer, Mario, additional, Sullivan, Nancy J., additional, Douek, Daniel C., additional, and Seder, Robert A., additional

Published
2022
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12. Development of an In Vivo Probe to Track SARS-CoV-2 Infection in Rhesus Macaques

Author

Madden, Patrick J., primary, Arif, Muhammad S., additional, Becker, Mark E., additional, McRaven, Michael D., additional, Carias, Ann M., additional, Lorenzo-Redondo, Ramon, additional, Xiao, Sixia, additional, Midkiff, Cecily C., additional, Blair, Robert V., additional, Potter, Elizabeth Lake, additional, Martin-Sancho, Laura, additional, Dodson, Alan, additional, Martinelli, Elena, additional, Todd, John-Paul M., additional, Villinger, Francois J., additional, Chanda, Sumit K., additional, Aye, Pyone Pyone, additional, Roy, Chad J., additional, Roederer, Mario, additional, Lewis, Mark G., additional, Veazey, Ronald S., additional, and Hope, Thomas J., additional

Published
2021
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13. Protection against SARS-CoV-2 Beta variant in mRNA-1273 vaccine–boosted nonhuman primates

Author

Corbett, Kizzmekia S., primary, Gagne, Matthew, additional, Wagner, Danielle A., additional, O’ Connell, Sarah, additional, Narpala, Sandeep R., additional, Flebbe, Dillon R., additional, Andrew, Shayne F., additional, Davis, Rachel L., additional, Flynn, Barbara, additional, Johnston, Timothy S., additional, Stringham, Christopher D., additional, Lai, Lilin, additional, Valentin, Daniel, additional, Van Ry, Alex, additional, Flinchbaugh, Zackery, additional, Werner, Anne P., additional, Moliva, Juan I., additional, Sriparna, Manjari, additional, O’Dell, Sijy, additional, Schmidt, Stephen D., additional, Tucker, Courtney, additional, Choi, Angela, additional, Koch, Matthew, additional, Bock, Kevin W., additional, Minai, Mahnaz, additional, Nagata, Bianca M., additional, Alvarado, Gabriela S., additional, Henry, Amy R., additional, Laboune, Farida, additional, Schramm, Chaim A., additional, Zhang, Yi, additional, Yang, Eun Sung, additional, Wang, Lingshu, additional, Choe, Misook, additional, Boyoglu-Barnum, Seyhan, additional, Wei, Shi, additional, Lamb, Evan, additional, Nurmukhambetova, Saule T., additional, Provost, Samantha J., additional, Donaldson, Mitzi M., additional, Marquez, Josue, additional, Todd, John-Paul M., additional, Cook, Anthony, additional, Dodson, Alan, additional, Pekosz, Andrew, additional, Boritz, Eli, additional, Ploquin, Aurélie, additional, Doria-Rose, Nicole, additional, Pessaint, Laurent, additional, Andersen, Hanne, additional, Foulds, Kathryn E., additional, Misasi, John, additional, Wu, Kai, additional, Carfi, Andrea, additional, Nason, Martha C., additional, Mascola, John, additional, Moore, Ian N., additional, Edwards, Darin K., additional, Lewis, Mark G., additional, Suthar, Mehul S., additional, Roederer, Mario, additional, McDermott, Adrian, additional, Douek, Daniel C., additional, Sullivan, Nancy J., additional, Graham, Barney S., additional, and Seder, Robert A., additional

Published
2021
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14. Protection from SARS-CoV-2 Delta one year after mRNA-1273 vaccination in nonhuman primates is coincident with an anamnestic antibody response in the lower airway

Author

Gagne, Matthew, primary, Corbett, Kizzmekia S., additional, Flynn, Barbara J., additional, Foulds, Kathryn E., additional, Wagner, Danielle A., additional, Andrew, Shayne F., additional, Todd, John-Paul M., additional, Honeycutt, Christopher Cole, additional, McCormick, Lauren, additional, Nurmukhambetova, Saule T., additional, Davis-Gardner, Meredith E., additional, Pessaint, Laurent, additional, Bock, Kevin W., additional, Nagata, Bianca M., additional, Minai, Mahnaz, additional, Werner, Anne P., additional, Moliva, Juan I., additional, Tucker, Courtney, additional, Lorang, Cynthia G., additional, Zhao, Bingchun, additional, McCarthy, Elizabeth, additional, Cook, Anthony, additional, Dodson, Alan, additional, Mudvari, Prakriti, additional, Roberts-Torres, Jesmine, additional, Laboune, Farida, additional, Wang, Lingshu, additional, Goode, Adrienne, additional, Kar, Swagata, additional, Boyoglu-Barnum, Seyhan, additional, Yang, Eun Sung, additional, Shi, Wei, additional, Ploquin, Aurélie, additional, Doria-Rose, Nicole, additional, Carfi, Andrea, additional, Mascola, John R., additional, Boritz, Eli A., additional, Edwards, Darin K., additional, Andersen, Hanne, additional, Lewis, Mark G., additional, Suthar, Mehul S., additional, Graham, Barney S., additional, Roederer, Mario, additional, Moore, Ian N., additional, Nason, Martha C., additional, Sullivan, Nancy J., additional, Douek, Daniel C., additional, and Seder, Robert A., additional

Published
2021
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15. Intradermal-delivered DNA vaccine induces durable immunity mediating a reduction in viral load in a rhesus macaque SARS-CoV-2 challenge model

Author

Patel, Ami, primary, Walters, Jewell N., additional, Reuschel, Emma L., additional, Schultheis, Katherine, additional, Parzych, Elizabeth, additional, Gary, Ebony N., additional, Maricic, Igor, additional, Purwar, Mansi, additional, Eblimit, Zeena, additional, Walker, Susanne N., additional, Guimet, Diana, additional, Bhojnagarwala, Pratik, additional, Adeniji, Opeyemi S., additional, Doan, Arthur, additional, Xu, Ziyang, additional, Elwood, Dustin, additional, Reeder, Sophia M., additional, Pessaint, Laurent, additional, Kim, Kevin Y., additional, Cook, Anthony, additional, Chokkalingam, Neethu, additional, Finneyfrock, Brad, additional, Tello-Ruiz, Edgar, additional, Dodson, Alan, additional, Choi, Jihae, additional, Generotti, Alison, additional, Harrison, John, additional, Tursi, Nicholas J., additional, Andrade, Viviane M., additional, Dia, Yaya, additional, Zaidi, Faraz I., additional, Andersen, Hanne, additional, Abdel-Mohsen, Mohamed, additional, Lewis, Mark G., additional, Muthumani, Kar, additional, Kim, J. Joseph, additional, Kulp, Daniel W., additional, Humeau, Laurent M., additional, Ramos, Stephanie J., additional, Smith, Trevor R.F., additional, Weiner, David B., additional, and Broderick, Kate E., additional

Published
2021
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16. Immune correlates of protection by mRNA-1273 vaccine against SARS-CoV-2 in nonhuman primates

Author

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

Published
2021
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17. Protective antibodies elicited by SARS-CoV-2 spike protein vaccination are boosted in the lung after challenge in nonhuman primates

Author

Francica, Joseph R., primary, Flynn, Barbara J., additional, Foulds, Kathryn E., additional, Noe, Amy T., additional, Werner, Anne P., additional, Moore, Ian N., additional, Gagne, Matthew, additional, Johnston, Timothy S., additional, Tucker, Courtney, additional, Davis, Rachel L., additional, Flach, Britta, additional, O’Connell, Sarah, additional, Andrew, Shayne F., additional, Lamb, Evan, additional, Flebbe, Dillon R., additional, Nurmukhambetova, Saule T., additional, Donaldson, Mitzi M., additional, Todd, John-Paul M., additional, Zhu, Alex Lee, additional, Atyeo, Caroline, additional, Fischinger, Stephanie, additional, Gorman, Matthew J, additional, Shin, Sally, additional, Edara, Venkata Viswanadh, additional, Floyd, Katharine, additional, Lai, Lilin, additional, Boyoglu-Barnum, Seyhan, additional, Van De Wetering, Renee, additional, Tylor, Alida, additional, McCarthy, Elizabeth, additional, Lecouturier, Valerie, additional, Ruiz, Sophie, additional, Berry, Catherine, additional, Tibbitts, Timothy, additional, Andersen, Hanne, additional, Cook, Anthony, additional, Dodson, Alan, additional, Pessaint, Laurent, additional, Van Ry, Alex, additional, Koutsoukos, Marguerite, additional, Gutzeit, Cindy, additional, Teng, I.-Ting, additional, Zhou, Tongqing, additional, Li, Dapeng, additional, Haynes, Barton F., additional, Kwong, Peter D., additional, McDermott, Adrian, additional, Lewis, Mark G., additional, Fu, Tong Ming, additional, Chicz, Roman, additional, van der Most, Robbert, additional, Corbett, Kizzmekia S., additional, Suthar, Mehul S., additional, Alter, Galit, additional, Roederer, Mario, additional, Sullivan, Nancy J., additional, Douek, Daniel C., additional, Graham, Barney S., additional, Casimiro, Danilo, additional, and Seder, Robert A., additional

Published
2021
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18. Protection against SARS-CoV-2 Beta Variant in mRNA-1273 Boosted Nonhuman Primates

Author

Corbett, Kizzmekia S., primary, Gagne, Matthew, additional, Wagner, Danielle A., additional, Connell, Sarah O’, additional, Narpala, Sandeep R., additional, Flebbe, Dillon R., additional, Andrew, Shayne F., additional, Davis, Rachel L., additional, Flynn, Barbara, additional, Johnston, Timothy S., additional, Stringham, Christopher, additional, Lai, Lilin, additional, Valentin, Daniel, additional, Van Ry, Alex, additional, Flinchbaugh, Zackery, additional, Werner, Anne P., additional, Moliva, Juan I., additional, Sriparna, Manjari, additional, O’Dell, Sijy, additional, Schmidt, Stephen D., additional, Tucker, Courtney, additional, Choi, Angela, additional, Koch, Matthew, additional, Bock, Kevin W., additional, Minai, Mahnaz, additional, Nagata, Bianca M., additional, Alvarado, Gabriela S., additional, Henry, Amy R., additional, Laboune, Farida, additional, Schramm, Chaim A., additional, Zhang, Yi, additional, Wang, Lingshu, additional, Choe, Misook, additional, Boyoglu-Barnum, Seyhan, additional, Shi, Wei, additional, Lamb, Evan, additional, Nurmukhambetova, Saule T., additional, Provost, Samantha J., additional, Donaldson, Mitzi M., additional, Marquez, Josue, additional, Todd, John-Paul M., additional, Cook, Anthony, additional, Dodson, Alan, additional, Pekosz, Andrew, additional, Boritz, Eli, additional, Ploquin, Aurélie, additional, Doria-Rose, Nicole, additional, Pessaint, Laurent, additional, Andersen, Hanne, additional, Foulds, Kathryn E., additional, Misasi, John, additional, Wu, Kai, additional, Carfi, Andrea, additional, Nason, Martha C., additional, Mascola, John, additional, Moore, Ian N., additional, Edwards, Darin K., additional, Lewis, Mark G., additional, Suthar, Mehul S., additional, Roederer, Mario, additional, McDermott, Adrian, additional, Douek, Daniel C., additional, Sullivan, Nancy J., additional, Graham, Barney S., additional, and Seder, Robert A., additional

Published
2021
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19. Evaluation of mRNA-1273 against SARS-CoV-2 B.1.351 Infection in Nonhuman Primates

Author

Corbett, Kizzmekia S., primary, Werner, Anne P., additional, O’ Connell, Sarah, additional, Gagne, Matthew, additional, Lai, Lilin, additional, Moliva, Juan I., additional, Flynn, Barbara, additional, Choi, Angela, additional, Koch, Matthew, additional, Foulds, Kathryn E., additional, Andrew, Shayne F., additional, Flebbe, Dillon R., additional, Lamb, Evan, additional, Nurmukhambetova, Saule T., additional, Provost, Samantha J., additional, Bock, Kevin W., additional, Minai, Mahnaz, additional, Nagata, Bianca M., additional, Van Ry, Alex, additional, Flinchbaugh, Zackery, additional, Johnston, Timothy S., additional, Mokhtari, Elham Bayat, additional, Mudvari, Prakriti, additional, Henry, Amy R., additional, Laboune, Farida, additional, Chang, Becky, additional, Porto, Maciel, additional, Wear, Jaclyn, additional, Alvarado, Gabriela S., additional, Boyoglu-Barnum, Seyhan, additional, Todd, John-Paul M., additional, Bart, Bridget, additional, Cook, Anthony, additional, Dodson, Alan, additional, Pessaint, Laurent, additional, Steingrebe, Katelyn, additional, Elbashir, Sayda, additional, Andersen, Hanne, additional, Wu, Kai, additional, Edwards, Darin K., additional, Kar, Swagata, additional, Lewis, Mark G., additional, Bortiz, Eli, additional, Moore, Ian N., additional, Carfi, Andrea, additional, Suthar, Mehul S., additional, McDermott, Adrian, additional, Roederer, Mario, additional, Nason, Martha C., additional, Sullivan, Nancy J., additional, Douek, Daniel C., additional, Graham, Barney S., additional, and Seder, Robert A., additional

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

Author

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

Published
2021
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21. Vaccination with SARS-CoV-2 Spike Protein and AS03 Adjuvant Induces Rapid Anamnestic Antibodies in the Lung and Protects Against Virus Challenge in Nonhuman Primates

Author

Francica, Joseph R., primary, Flynn, Barbara J., additional, Foulds, Kathryn E., additional, Noe, Amy T., additional, Werner, Anne P., additional, Moore, Ian N., additional, Gagne, Matthew, additional, Johnston, Timothy S., additional, Tucker, Courtney, additional, Davis, Rachel L., additional, Flach, Britta, additional, O’Connell, Sarah, additional, Andrew, Shayne F., additional, Lamb, Evan, additional, Flebbe, Dillon R., additional, Nurmukhambetova, Saule T., additional, Donaldson, Mitzi M., additional, Todd, John-Paul M., additional, Zhu, Alex Lee, additional, Atyeo, Caroline, additional, Fischinger, Stephanie, additional, Gorman, Matthew J, additional, Shin, Sally, additional, Edara, Venkata Viswanadh, additional, Floyd, Katharine, additional, Lai, Lilin, additional, Tylor, Alida, additional, McCarthy, Elizabeth, additional, Lecouturier, Valerie, additional, Ruiz, Sophie, additional, Berry, Catherine, additional, Tibbitts, Timothy, additional, Andersen, Hanne, additional, Cook, Anthony, additional, Dodson, Alan, additional, Pessaint, Laurent, additional, Ry, Alex Van, additional, Koutsoukos, Marguerite, additional, Gutzeit, Cindy, additional, Teng, I-Ting, additional, Zhou, Tongqing, additional, Li, Dapeng, additional, Haynes, Barton F., additional, Kwong, Peter D., additional, McDermott, Adrian, additional, Lewis, Mark G., additional, Fu, Tong Ming, additional, Chicz, Roman, additional, van der Most, Robbert, additional, Corbett, Kizzmekia S., additional, Suthar, Mehul S., additional, Alter, Galit, additional, Roederer, Mario, additional, Sullivan, Nancy J., additional, Douek, Daniel C., additional, Graham, Barney S., additional, Casimiro, Danilo, additional, and Seder, Robert A., additional

Published
2021
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22. Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates

Author

Corbett, Kizzmekia S., primary, Flynn, Barbara, additional, Foulds, Kathryn E., additional, Francica, Joseph R., additional, Boyoglu-Barnum, Seyhan, additional, Werner, Anne P., additional, Flach, Britta, additional, O’Connell, Sarah, additional, Bock, Kevin W., additional, Minai, Mahnaz, additional, Nagata, Bianca M., additional, Andersen, Hanne, additional, Martinez, David R., additional, Noe, Amy T., additional, Douek, Naomi, additional, Donaldson, Mitzi M., additional, Nji, Nadesh N., additional, Alvarado, Gabriela S., additional, Edwards, Darin K., additional, Flebbe, Dillon R., additional, Lamb, Evan, additional, Doria-Rose, Nicole A., additional, Lin, Bob C., additional, Louder, Mark K., additional, O’Dell, Sijy, additional, Schmidt, Stephen D., additional, Phung, Emily, additional, Chang, Lauren A., additional, Yap, Christina, additional, Todd, John-Paul M., additional, Pessaint, Laurent, additional, Van Ry, Alex, additional, Browne, Shanai, additional, Greenhouse, Jack, additional, Putman-Taylor, Tammy, additional, Strasbaugh, Amanda, additional, Campbell, Tracey-Ann, additional, Cook, Anthony, additional, Dodson, Alan, additional, Steingrebe, Katelyn, additional, Shi, Wei, additional, Zhang, Yi, additional, Abiona, Olubukola M., additional, Wang, Lingshu, additional, Pegu, Amarendra, additional, Yang, Eun Sung, additional, Leung, Kwanyee, additional, Zhou, Tongqing, additional, Teng, I-Ting, additional, Widge, Alicia, additional, Gordon, Ingelise, additional, Novik, Laura, additional, Gillespie, Rebecca A., additional, Loomis, Rebecca J., additional, Moliva, Juan I., additional, Stewart-Jones, Guillaume, additional, Himansu, Sunny, additional, Kong, Wing-Pui, additional, Nason, Martha C., additional, Morabito, Kaitlyn M., additional, Ruckwardt, Tracy J., additional, Ledgerwood, Julie E., additional, Gaudinski, Martin R., additional, Kwong, Peter D., additional, Mascola, John R., additional, Carfi, Andrea, additional, Lewis, Mark G., additional, Baric, Ralph S., additional, McDermott, Adrian, additional, Moore, Ian N., additional, Sullivan, Nancy J., additional, Roederer, Mario, additional, Seder, Robert A., additional, and Graham, Barney S., additional

Published
2020
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23. Intradermal-delivered DNA vaccine provides anamnestic protection in a rhesus macaque SARS-CoV-2 challenge model

Author

Patel, Ami, primary, Walters, Jewell, additional, Reuschel, Emma L., additional, Schultheis, Katherine, additional, Parzych, Elizabeth, additional, Gary, Ebony N., additional, Maricic, Igor, additional, Purwar, Mansi, additional, Eblimit, Zeena, additional, Walker, Susanne N., additional, Guimet, Diana, additional, Bhojnagarwala, Pratik, additional, Doan, Arthur, additional, Xu, Ziyang, additional, Elwood, Dustin, additional, Reeder, Sophia M., additional, Pessaint, Laurent, additional, Kim, Kevin Y., additional, Cook, Anthony, additional, Chokkalingam, Neethu, additional, Finneyfrock, Brad, additional, Tello-Ruiz, Edgar, additional, Dodson, Alan, additional, Choi, Jihae, additional, Generotti, Alison, additional, Harrison, John, additional, Tursi, Nicholas J., additional, Andrade, Viviane M., additional, Dia, Yaya, additional, Zaidi, Faraz I., additional, Andersen, Hanne, additional, Lewis, Mark G., additional, Muthumani, Kar, additional, Kim, J Joseph, additional, Kulp, Daniel W., additional, Humeau, Laurent M., additional, Ramos, Stephanie, additional, Smith, Trevor R.F., additional, Weiner, David B., additional, and Broderick, Kate E., additional

Published
2020
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24. 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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26. Correction

Author

Dodson, Alan and Hesselbring, Bobbie

Subjects
Travel, recreation and leisure
Abstract

In your April issue, Rood Foodie section, I got lost going 'an hour or so north of Dallas-Fort Worth' to get to Brenham. It is actually about four hours south [...]

Published
2015

27. Durable immunity to SARS-CoV-2 in both lower and upper airways achieved with a gorilla adenovirus (GRAd) S-2P vaccine in non-human primates.

Author

Moliva JI, Andrew SF, Flynn BJ, Wagner DA, Foulds KE, Gagne M, Flebbe DR, Lamb E, Provost S, Marquez J, Mychalowych A, Lorag CG, Honeycutt CC, Burnett MR, McCormick L, Henry AR, Godbole S, Davis-Gardner ME, Minai M, Bock KW, Nagata BM, Todd JM, McCarthy E, Dodson A, Kouneski K, Cook A, Pessaint L, Ry AV, Valentin D, Young S, Littman Y, Boon ACM, Suthar MS, Lewis MG, Andersen H, Alves DA, Woodward R, Leuzzi A, Vitelli A, Colloca S, Folgori A, Raggiolli A, Capone S, Nason MC, Douek DC, Roederer M, Seder RA, and Sullivan NJ

Abstract

SARS-CoV-2 continues to pose a global threat, and current vaccines, while effective against severe illness, fall short in preventing transmission. To address this challenge, there's a need for vaccines that induce mucosal immunity and can rapidly control the virus. In this study, we demonstrate that a single immunization with a novel gorilla adenovirus-based vaccine (GRAd) carrying the pre-fusion stabilized Spike protein (S-2P) in non-human primates provided protective immunity for over one year against the BA.5 variant of SARS-CoV-2. A prime-boost regimen using GRAd followed by adjuvanted S-2P (GRAd+S-2P) accelerated viral clearance in both the lower and upper airways. GRAd delivered via aerosol (GRAd(AE)+S-2P) modestly improved protection compared to its matched intramuscular regimen, but showed dramatically superior boosting by mRNA and, importantly, total virus clearance in the upper airway by day 4 post infection. GrAd vaccination regimens elicited robust and durable systemic and mucosal antibody responses to multiple SARS-CoV-2 variants, but only GRAd(AE)+S-2P generated long-lasting T cell responses in the lung. This research underscores the flexibility of the GRAd vaccine platform to provide durable immunity against SARS-CoV-2 in both the lower and upper airways., Competing Interests: Declaration of interests M.R., N.J.S., and D.C.D. are inventors on U.S. Patent Application No. 63/147,419 entitled “Antibodies Targeting the Spike Protein of Coronaviruses”. L.P., A.V.R., D.V., A.C., A.D., M.G.L., and H.A. are employees of Bioqual, Inc. A.L., A.V., S.Co., A.F., A.R., and S.Ca. are employees of ReiThera Srl. S.Co. and A.F. are shareholders of Keires AG. A.V., S.Co. and A.R. are named inventors of the Patent Application No. 20183515.4 entitled “Gorilla Adenovirus Nucleic Acid- and Amino Acid-Sequences, Vectors Containing Same, and Uses Thereof”. The other authors declare no competing interests.

Published
2023
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28. Mucosal Adenoviral-vectored Vaccine Boosting Durably Prevents XBB.1.16 Infection in Nonhuman Primates.

Author

Gagne M, Flynn BJ, Andrew SF, Flebbe DR, Mychalowych A, Lamb E, Davis-Gardner ME, Burnett MR, Serebryannyy LA, Lin BC, Pessaint L, Todd JM, Ziff ZE, Maule E, Carroll R, Naisan M, Jethmalani Y, Case JB, Dmitriev IP, Kashentseva EA, Ying B, Dodson A, Kouneski K, Doria-Rose NA, O'Dell S, Godbole S, Laboune F, Henry AR, Marquez J, Teng IT, Wang L, Zhou Q, Wali B, Ellis M, Zouantchangadou S, Ry AV, Lewis MG, Andersen H, Kwong PD, Curiel DT, Foulds KE, Nason MC, Suthar MS, Roederer M, Diamond MS, Douek DC, and Seder RA

Abstract

Waning immunity and continued virus evolution have limited the durability of protection from symptomatic infection mediated by intramuscularly (IM)-delivered mRNA vaccines against COVID-19 although protection from severe disease remains high. Mucosal vaccination has been proposed as a strategy to increase protection at the site of SARS-CoV-2 infection by enhancing airway immunity, potentially reducing rates of infection and transmission. Here, we compared protection against XBB.1.16 virus challenge 5 months following IM or mucosal boosting in non-human primates (NHP) that had previously received a two-dose mRNA-1273 primary vaccine regimen. The mucosal boost was composed of a bivalent chimpanzee adenoviral-vectored vaccine encoding for both SARS-CoV-2 WA1 and BA.5 spike proteins (ChAd-SARS-CoV-2-S) and delivered either by an intranasal mist or an inhaled aerosol. An additional group of animals was boosted by the IM route with bivalent WA1/BA.5 spike-matched mRNA (mRNA-1273.222) as a benchmark control. NHP were challenged in the upper and lower airways 18 weeks after boosting with XBB.1.16, a heterologous Omicron lineage strain. Cohorts boosted with ChAd-SARS-CoV-2-S by an aerosolized or intranasal route had low to undetectable virus replication as assessed by levels of subgenomic SARS-CoV-2 RNA in the lungs and nose, respectively. In contrast, animals that received the mRNA-1273.222 boost by the IM route showed minimal protection against virus replication in the upper airway but substantial reduction of virus RNA levels in the lower airway. Immune analysis showed that the mucosal vaccines elicited more durable antibody and T cell responses than the IM vaccine. Protection elicited by the aerosolized vaccine was associated with mucosal IgG and IgA responses, whereas protection elicited by intranasal delivery was mediated primarily by mucosal IgA. Thus, durable immunity and effective protection against a highly transmissible heterologous variant in both the upper and lower airways can be achieved by mucosal delivery of a virus-vectored vaccine. Our study provides a template for the development of mucosal vaccines that limit infection and transmission against respiratory pathogens.

Published
2023
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29. RBD-based high affinity ACE2 antagonist limits SARS-CoV-2 replication in upper and lower airways.

Author

Gagne M, Flynn BJ, Honeycutt CC, Flebbe DR, Andrew SF, Provost SJ, McCormick L, Van Ry A, McCarthy E, Todd JM, Bao S, Teng IT, Marciano S, Rudich Y, Li C, Pessaint L, Dodson A, Cook A, Lewis MG, Andersen H, Zahradník J, Nason MC, Foulds KE, Kwong PD, Roederer M, Schreiber G, Seder RA, and Douek DC

Abstract

SARS-CoV-2 has the capacity to evolve mutations to escape vaccine-and infection-acquired immunity and antiviral drugs. A variant-agnostic therapeutic agent that protects against severe disease without putting selective pressure on the virus would thus be a valuable biomedical tool. Here, we challenged rhesus macaques with SARS-CoV-2 Delta and simultaneously treated them with aerosolized RBD-62, a protein developed through multiple rounds of in vitro evolution of SARS-CoV-2 RBD to acquire 1000-fold enhanced ACE2 binding affinity. RBD-62 treatment gave equivalent protection in upper and lower airways, a phenomenon not previously observed with clinically approved vaccines. Importantly, RBD-62 did not block the development of memory responses to Delta and did not elicit anti-drug immunity. These data provide proof-of-concept that RBD-62 can prevent severe disease from a highly virulent variant.

Published
2023
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30. Protection from SARS-CoV-2 Delta one year after mRNA-1273 vaccination in nonhuman primates is coincident with an anamnestic antibody response in the lower airway.

Author

Gagne M, Corbett KS, Flynn BJ, Foulds KE, Wagner DA, Andrew SF, Todd JM, Honeycutt CC, McCormick L, Nurmukhambetova ST, Davis-Gardner ME, Pessaint L, Bock KW, Nagata BM, Minai M, Werner AP, Moliva JI, Tucker C, Lorang CG, Zhao B, McCarthy E, Cook A, Dodson A, Mudvari P, Roberts-Torres J, Laboune F, Wang L, Goode A, Kar S, Boyoglu-Barnum S, Yang ES, Shi W, Ploquin A, Doria-Rose N, Carfi A, Mascola JR, Boritz EA, Edwards DK, Andersen H, Lewis MG, Suthar MS, Graham BS, Roederer M, Moore IN, Nason MC, Sullivan NJ, Douek DC, and Seder RA

Abstract

mRNA-1273 vaccine efficacy against SARS-CoV-2 Delta wanes over time; however, there are limited data on the impact of durability of immune responses on protection. We immunized rhesus macaques at weeks 0 and 4 and assessed immune responses over one year in blood, upper and lower airways. Serum neutralizing titers to Delta were 280 and 34 reciprocal ID 50 at weeks 6 (peak) and 48 (challenge), respectively. Antibody binding titers also decreased in bronchoalveolar lavage (BAL). Four days after challenge, virus was unculturable in BAL and subgenomic RNA declined ∼3-log 10 compared to control animals. In nasal swabs, sgRNA declined 1-log 10 and virus remained culturable. Anamnestic antibody responses (590-fold increase) but not T cell responses were detected in BAL by day 4 post-challenge. mRNA-1273-mediated protection in the lungs is durable but delayed and potentially dependent on anamnestic antibody responses. Rapid and sustained protection in upper and lower airways may eventually require a boost.

Published
2021
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31. Protection against SARS-CoV-2 Beta Variant in mRNA-1273 Boosted Nonhuman Primates.

Author

Corbett KS, Gagne M, Wagner DA, Connell SO, Narpala SR, Flebbe DR, Andrew SF, Davis RL, Flynn B, Johnston TS, Stringham C, Lai L, Valentin D, Van Ry A, Flinchbaugh Z, Werner AP, Moliva JI, Sriparna M, O'Dell S, Schmidt SD, Tucker C, Choi A, Koch M, Bock KW, Minai M, Nagata BM, Alvarado GS, Henry AR, Laboune F, Schramm CA, Zhang Y, Wang L, Choe M, Boyoglu-Barnum S, Shi W, Lamb E, Nurmukhambetova ST, Provost SJ, Donaldson MM, Marquez J, Todd JM, Cook A, Dodson A, Pekosz A, Boritz E, Ploquin A, Doria-Rose N, Pessaint L, Andersen H, Foulds KE, Misasi J, Wu K, Carfi A, Nason MC, Mascola J, Moore IN, Edwards DK, Lewis MG, Suthar MS, Roederer M, McDermott A, Douek DC, Sullivan NJ, Graham BS, and Seder RA

Abstract

Neutralizing antibody responses gradually wane after vaccination with mRNA-1273 against several variants of concern (VOC), and additional boost vaccinations may be required to sustain immunity and protection. Here, we evaluated the immune responses in nonhuman primates that received 100 µg of mRNA-1273 vaccine at 0 and 4 weeks and were boosted at week 29 with mRNA-1273 (homologous) or mRNA-1273.β (heterologous), which encompasses the spike sequence of the B.1.351 (beta or β) variant. Reciprocal ID 50 pseudovirus neutralizing antibody geometric mean titers (GMT) against live SARS-CoV-2 D614G and the β variant, were 4700 and 765, respectively, at week 6, the peak of primary response, and 644 and 553, respectively, at a 5-month post-vaccination memory time point. Two weeks following homologous or heterologous boost β-specific reciprocal ID 50 GMT were 5000 and 3000, respectively. At week 38, animals were challenged in the upper and lower airway with the β variant. Two days post-challenge, viral replication was low to undetectable in both BAL and nasal swabs in most of the boosted animals. These data show that boosting with the homologous mRNA-1273 vaccine six months after primary immunization provides up to a 20-fold increase in neutralizing antibody responses across all VOC, which may be required to sustain high-level protection against severe disease, especially for at-risk populations., One-Sentence Summary: mRNA-1273 boosted nonhuman primates have increased immune responses and are protected against SARS-CoV-2 beta infection.

Published
2021
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32. Evaluation of mRNA-1273 against SARS-CoV-2 B.1.351 Infection in Nonhuman Primates.

Author

Corbett KS, Werner AP, O' Connell S, Gagne M, Lai L, Moliva JI, Flynn B, Choi A, Koch M, Foulds KE, Andrew SF, Flebbe DR, Lamb E, Nurmukhambetova ST, Provost SJ, Bock KW, Minai M, Nagata BM, Van Ry A, Flinchbaugh Z, Johnston TS, Mokhtari EB, Mudvari P, Henry AR, Laboune F, Chang B, Porto M, Wear J, Alvarado GS, Boyoglu-Barnum S, Todd JM, Bart B, Cook A, Dodson A, Pessaint L, Steingrebe K, Elbashir S, Andersen H, Wu K, Edwards DK, Kar S, Lewis MG, Bortiz E, Moore IN, Carfi A, Suthar MS, McDermott A, Roederer M, Nason MC, Sullivan NJ, Douek DC, Graham BS, and Seder RA

Abstract

Background: Vaccine efficacy against the B.1.351 variant following mRNA-1273 vaccination in humans has not been determined. Nonhuman primates (NHP) are a useful model for demonstrating whether mRNA-1273 mediates protection against B.1.351., Methods: Nonhuman primates received 30 or 100 µg of mRNA-1273 as a prime-boost vaccine at 0 and 4 weeks, a single immunization of 30 µg at week 0, or no vaccine. Antibody and T cell responses were assessed in blood, bronchioalveolar lavages (BAL), and nasal washes. Viral replication in BAL and nasal swabs were determined by qRT-PCR for sgRNA, and histopathology and viral antigen quantification were performed on lung tissue post-challenge., Results: Eight weeks post-boost, 100 µg x2 of mRNA-1273 induced reciprocal ID 50 neutralizing geometric mean titers against live SARS-CoV-2 D614G and B.1.351 of 3300 and 240, respectively, and 430 and 84 for the 30 µg x2 group. There were no detectable neutralizing antibodies against B.1351 after the single immunization of 30 µg. On day 2 following B.1.351 challenge, sgRNA in BAL was undetectable in 6 of 8 NHP that received 100 µg x2 of mRNA-1273, and there was a ∼2-log reduction in sgRNA in NHP that received two doses of 30 µg compared to controls. In nasal swabs, there was a 1-log 10 reduction observed in the 100 µg x2 group. There was limited inflammation or viral antigen in lungs of vaccinated NHP post-challenge., Conclusions: Immunization with two doses of mRNA-1273 achieves effective immunity that rapidly controls lower and upper airway viral replication against the B.1.351 variant in NHP.

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

Author

Corbett KS, Nason MC, Flach B, Gagne M, O' Connell S, Johnston TS, Shah SN, Edara VV, Floyd K, Lai L, McDanal C, Francica JR, Flynn B, Wu K, Choi A, Koch M, Abiona OM, Werner AP, Alvarado GS, Andrew SF, Donaldson MM, Fintzi J, Flebbe DR, Lamb E, Noe AT, Nurmukhambetova ST, Provost SJ, Cook A, Dodson A, Faudree A, Greenhouse J, Kar S, Pessaint L, Porto M, Steingrebe K, Valentin D, Zouantcha S, Bock KW, Minai M, Nagata BM, Moliva JI, van de Wetering R, Boyoglu-Barnum S, Leung K, Shi W, Yang ES, Zhang Y, Todd JM, Wang L, Andersen H, Foulds KE, Edwards DK, Mascola JR, Moore IN, Lewis MG, Carfi A, Montefiori D, Suthar MS, McDermott A, Sullivan NJ, Roederer M, Douek DC, Graham BS, and Seder RA

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 Summary: 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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34. Vaccination with SARS-CoV-2 Spike Protein and AS03 Adjuvant Induces Rapid Anamnestic Antibodies in the Lung and Protects Against Virus Challenge in Nonhuman Primates.

Author

Francica JR, Flynn BJ, Foulds KE, Noe AT, Werner AP, Moore IN, Gagne M, Johnston TS, Tucker C, Davis RL, Flach B, O'Connell S, Andrew SF, Lamb E, Flebbe DR, Nurmukhambetova ST, Donaldson MM, Todd JM, Zhu AL, Atyeo C, Fischinger S, Gorman MJ, Shin S, Edara VV, Floyd K, Lai L, Tylor A, McCarthy E, Lecouturier V, Ruiz S, Berry C, Tibbitts T, Andersen H, Cook A, Dodson A, Pessaint L, Ry AV, Koutsoukos M, Gutzeit C, Teng IT, Zhou T, Li D, Haynes BF, Kwong PD, McDermott A, Lewis MG, Fu TM, Chicz R, van der Most R, Corbett KS, Suthar MS, Alter G, Roederer M, Sullivan NJ, Douek DC, Graham BS, Casimiro D, and Seder RA

Abstract

Adjuvanted soluble protein vaccines have been used extensively in humans for protection against various viral infections based on their robust induction of antibody responses. Here, soluble prefusion-stabilized spike trimers (preS dTM) from the severe acute respiratory syndrome coronavirus (SARS-CoV-2) were formulated with the adjuvant AS03 and administered twice to nonhuman primates (NHP). Binding and functional neutralization assays and systems serology revealed that NHP developed AS03-dependent multi-functional humoral responses that targeted multiple spike domains and bound to a variety of antibody F C receptors mediating effector functions in vitro . Pseudovirus and live virus neutralizing IC 50 titers were on average greater than 1000 and significantly higher than a panel of human convalescent sera. NHP were challenged intranasally and intratracheally with a high dose (3×10 6 PFU) of SARS-CoV-2 (USA-WA1/2020 isolate). Two days post-challenge, vaccinated NHP showed rapid control of viral replication in both the upper and lower airways. Notably, vaccinated NHP also had increased spike-specific IgG antibody responses in the lung as early as 2 days post challenge. Moreover, vaccine-induced IgG mediated protection from SARS-CoV-2 challenge following passive transfer to hamsters. These data show that antibodies induced by the AS03-adjuvanted preS dTM vaccine are sufficient to mediate protection against SARS-CoV-2 and support the evaluation of this vaccine in human clinical trials., Competing Interests: Declaration of interests All authors have declared the following interests: VL, TB, CB, SR, TMF, DC, RC are Sanofi Pasteur employees and may hold stock. MK, RvdM, and CG are employees of the GSK group of companies and report ownership of GSK shares.

Published
2021
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