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1. Phase 1 dose-escalation trial evaluating a group 2 influenza hemagglutinin stabilized stem nanoparticle vaccine

Author

Casazza, Joseph P., Hofstetter, Amelia R., Costner, Pamela J. M., Holman, LaSonji A., Hendel, Cynthia S., Widge, Alicia T., Wu, Richard L., Whalen, William R., Cunningham, Jennifer, Arthur, Anita, Wang, Xiaolin, Ola, Abidemi, Saunders, Jamie, Mendoza, Floreliz, Novik, Laura, Burgos Florez, Maria C., Ortega-Villa, Ana M., Apte, Preeti J., Strom, Larisa, Wang, Lu, Imam, Marjaan, Basappa, Manjula, Naisan, Mursal, Castro, Mike, Trost, Jessica F., Narpala, Sandeep R., Vanderven, Hillary A., Yamshchikov, Galina V., Berkowitz, Nina M., Gordon, Ingelise J., Plummer, Sarah H., Wycuff, Diane L., Vazquez, Sandra, Gillespie, Rebecca A., Creanga, Adrian, Adams, William C., Carlton, Kevin, Gall, Jason G., McDermott, Adrian B., Serebryannyy, Leonid A., Houser, Katherine V., Koup, Richard A., Graham, Barney S., Ledgerwood, Julie E., Mascola, John R., Pierson, Theodore C., Andrews, Sarah F., Kanekiyo, Masaru, and Dropulic, Lesia K.

Published
2024
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2. Low-dose intravenous and subcutaneous CIS43LS monoclonal antibody for protection against malaria (VRC 612 Part C): a phase 1, adaptive trial

Author

Young, Cheryl, Boyce, Colleen, Winkler, Jennifer, Holian, Susan, Greenberg, Nancy, George, Shirley, Kwon, Alyson, Dorsey, Brenda, Da Costa, Ana Raquel, Witt, William, Grays, Daryl, Gapasin, Arren, Bernal, Paula, Floyd, Jeffrey, Goldstein, Eric, Howe, Leslie, Lee, Myounghee, Marron, Jennifer, Brooks, Kelly, Turek, Lisa, Farley, Patricia, Frels, Shantel, Booth, Delores, Gall, Jason, Carlton, Kevin, Albright, Gabriela, Amharref, Nadia, Atallah, Kandace, Banappagari, Sashikanth, Bastani, Niutish, Blackstock, Daniel, Boonyaratanakornkit, Bobby, Carey, Elizabeth, Charlton, Adam, Chaudhuri, Rajoshi, Caringal, Alegria M., Chen, Mingzhong, Chen, Peifeng, Cheng, Wei, Gowetski, Daniel, Gulla, Krishana, Hastings, Erica, Horwitz, Joe, Ivleva, Vera, Kordella, Dan, Kueltzo, Lisa A., Lagler, Sara, Le, Matt, Lee, James, Lei, Paula, Li, Yile, Nagy, Attila, Patel, Aakash, Runsewe, Peyi, Shadrick, Will, Shetty, Shamitha, Wang, Hairong, Webber, Calvin, Vejzagic, Farah, Yang, Yoo-Jung, Lyke, Kirsten E, Berry, Andrea A, Mason, Kaitlin, Idris, Azza H, O'Callahan, Mark, Happe, Myra, Strom, Larisa, Berkowitz, Nina M, Guech, Mercy, Hu, Zonghui, Castro, Mike, Basappa, Manjula, Wang, Lu, Low, Kwang, Holman, LaSonji A, Mendoza, Floreliz, Gordon, Ingelise J, Plummer, Sarah H, Trofymenko, Olga, Strauss, Kathleen S, Joshi, Sudhaunshu, Shrestha, Biraj, Adams, Matthew, Chagas, Andrezza Campos, Murphy, Jittawadee R, Stein, Judy, Hickman, Somia, McDougal, Andrew, Lin, Bob, Narpala, Sandeep R, Vazquez, Sandra, Serebryannyy, Leonid, McDermott, Adrian, Gaudinski, Martin R, Capparelli, Edmund V, Coates, Emily E, Wu, Richard L, Ledgerwood, Julie E, Dropulic, Lesia K, and Seder, Robert A

Published
2023
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3. Safety and immunogenicity of an HIV-1 prefusion-stabilized envelope trimer (Trimer 4571) vaccine in healthy adults: A first-in-human open-label, randomized, dose-escalation, phase 1 clinical trial

Author

Houser, Katherine V., Gaudinski, Martin R., Happe, Myra, Narpala, Sandeep, Verardi, Raffaello, Sarfo, Edward K., Corrigan, Angela R., Wu, Richard, Rothwell, Ro Shauna, Novik, Laura, Hendel, Cynthia S., Gordon, Ingelise J., Berkowitz, Nina M., Cartagena, Cora Trelles, Widge, Alicia T., Coates, Emily E., Strom, Larisa, Hickman, Somia, Conan-Cibotti, Michelle, Vazquez, Sandra, Trofymenko, Olga, Plummer, Sarah, Stein, Judy, Case, Christopher L., Nason, Martha, Biju, Andrea, Parchment, Danealle K., Changela, Anita, Cheng, Cheng, Duan, Hongying, Geng, Hui, Teng, I-Ting, Zhou, Tongqing, O'Connell, Sarah, Barry, Chris, Carlton, Kevin, Gall, Jason G., Flach, Britta, Doria-Rose, Nicole A., Graham, Barney S., Koup, Richard A., McDermott, Adrian B., Mascola, John R., Kwong, Peter D., and Ledgerwood, Julie E.

Published
2022
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4. Safety and immunogenicity of a ferritin nanoparticle H2 influenza vaccine in healthy adults: a phase 1 trial

Author

Houser, Katherine V., Chen, Grace L., Carter, Cristina, Crank, Michelle C., Nguyen, Thuy A., Burgos Florez, Maria Claudia, Berkowitz, Nina M., Mendoza, Floreliz, Hendel, Cynthia Starr, Gordon, Ingelise J., Coates, Emily E., Vazquez, Sandra, Stein, Judy, Case, Christopher L., Lawlor, Heather, Carlton, Kevin, Gaudinski, Martin R., Strom, Larisa, Hofstetter, Amelia R., Liang, C. Jason, Narpala, Sandeep, Hatcher, Christian, Gillespie, Rebecca A., Creanga, Adrian, Kanekiyo, Masaru, Raab, Julie E., Andrews, Sarah F., Zhang, Yi, Yang, Eun Sung, Wang, Lingshu, Leung, Kwanyee, Kong, Wing-Pui, Freyn, Alec W., Nachbagauer, Raffael, Palese, Peter, Bailer, Robert T., McDermott, Adrian B., Koup, Richard A., Gall, Jason G., Arnold, Frank, Mascola, John R., Graham, Barney S., and Ledgerwood, Julie E.

Published
2022
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5. Safety, tolerability, and immunogenicity of the respiratory syncytial virus prefusion F subunit vaccine DS-Cav1: a phase 1, randomised, open-label, dose-escalation clinical trial

Author

Arthur, Anita, Cunningham, Jennifer, Eshun, Aba, Larkin, Brenda, Mendoza, Floreliz, Novik, Laura, Saunders, Jamie, Wang, Xiaolin, Whalen, William, Carter, Cristina, Hendel, Cynthia Starr, Plummer, Sarah, Ola, Abidemi, Widge, Alicia, Burgos Florez, Maria C, Le, Lam, Pittman, Iris, Rothwell, Ro Shauna S, Trofymenko, Olga, Vasilenko, Olga, Apte, Preeti, Hicks, Renunda, Cartagena, Cora Trelles, Williams, Pernell, Requilman, LaShawn, Tran, Colin, Bai, Shufeng, Carey, Elizabeth, Chamberlain, Amy L, Chang, Ya-chen, Chen, Mingzhong, Chen, Peifeng, Cooper, Jon, Fridley, Colleen, Ghosh, Mridul, Gollapudi, Deepika, Holland-Linn, Janel, Horwitz, Joe, Hussain, Althaf, Ivleva, Vera, Kaltovich, Florence, Leach, Kristin, Lee, Christopher, Liu, Amy, Liu, Xun, Manceva, Slobodanka, Menon, Amritha, Nagy, Attila, O'Connell, Sarah, Ragunathan, Rahul, Walters, Jennifer, Zhao, Zhong, Ruckwardt, Tracy J, Morabito, Kaitlyn M, Phung, Emily, Crank, Michelle C, Costner, Pamela J, Holman, LaSonji A, Chang, Lauren A, Hickman, Somia P, Berkowitz, Nina M, Gordon, Ingelise J, Yamshchikov, Galina V, Gaudinski, Martin R, Lin, Bob, Bailer, Robert, Chen, Man, Ortega-Villa, Ana M, Nguyen, Thuy, Kumar, Azad, Schwartz, Richard M, Kueltzo, Lisa A, Stein, Judith A, Carlton, Kevin, Gall, Jason G, Nason, Martha C, Mascola, John R, Chen, Grace, and Graham, Barney S

Published
2021
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6. Attenuated PfSPZ Vaccine induces strain-transcending T cells and durable protection against heterologous controlled human malaria infection

Author

Lyke, Kirsten E., Ishizuka, Andrew S., Berry, Andrea A., Chakravarty, Sumana, DeZure, Adam, Enama, Mary E., James, Eric R., Billingsley, Peter F., Gunasekera, Anusha, Manoj, Anita, Li, Minglin, Ruben, Adam J., Li, Tao, Eappen, Abraham G., Stafford, Richard E., KC, Natasha, Murshedkar, Tooba, Mendoza, Floreliz H., Gordon, Ingelise J., Zephir, Kathryn L., Holman, LaSonji A., Plummer, Sarah H., Hendel, Cynthia S., Novik, Laura, Costner, Pamela J. M., Saunders, Jamie G., Berkowitz, Nina M., Flynn, Barbara J., Nason, Martha C., Garver, Lindsay S., Laurens, Matthew B., Plowe, Christopher V., Richie, Thomas L., Graham, Barney S., Roederer, Mario, Sim, B. Kim Lee, Ledgerwood, Julie E., Hoffman, Stephen L., and Seder, Robert A.

Published
2017

8. Low-dose intravenous and subcutaneous CIS43LS monoclonal antibody for protection against malaria (VRC 612 Part C): a phase 1, adaptive trial

Author

Lyke, Kirsten E, primary, Berry, Andrea A, additional, Mason, Kaitlin, additional, Idris, Azza H, additional, O'Callahan, Mark, additional, Happe, Myra, additional, Strom, Larisa, additional, Berkowitz, Nina M, additional, Guech, Mercy, additional, Hu, Zonghui, additional, Castro, Mike, additional, Basappa, Manjula, additional, Wang, Lu, additional, Low, Kwang, additional, Holman, LaSonji A, additional, Mendoza, Floreliz, additional, Gordon, Ingelise J, additional, Plummer, Sarah H, additional, Trofymenko, Olga, additional, Strauss, Kathleen S, additional, Joshi, Sudhaunshu, additional, Shrestha, Biraj, additional, Adams, Matthew, additional, Chagas, Andrezza Campos, additional, Murphy, Jittawadee R, additional, Stein, Judy, additional, Hickman, Somia, additional, McDougal, Andrew, additional, Lin, Bob, additional, Narpala, Sandeep R, additional, Vazquez, Sandra, additional, Serebryannyy, Leonid, additional, McDermott, Adrian, additional, Gaudinski, Martin R, additional, Capparelli, Edmund V, additional, Coates, Emily E, additional, Wu, Richard L, additional, Ledgerwood, Julie E, additional, Dropulic, Lesia K, additional, Seder, Robert A, additional, Young, Cheryl, additional, Boyce, Colleen, additional, Winkler, Jennifer, additional, Holian, Susan, additional, Greenberg, Nancy, additional, George, Shirley, additional, Kwon, Alyson, additional, Dorsey, Brenda, additional, Da Costa, Ana Raquel, additional, Witt, William, additional, Grays, Daryl, additional, Gapasin, Arren, additional, Bernal, Paula, additional, Floyd, Jeffrey, additional, Goldstein, Eric, additional, Howe, Leslie, additional, Lee, Myounghee, additional, Marron, Jennifer, additional, Brooks, Kelly, additional, Turek, Lisa, additional, Farley, Patricia, additional, Frels, Shantel, additional, Booth, Delores, additional, Gall, Jason, additional, Carlton, Kevin, additional, Albright, Gabriela, additional, Amharref, Nadia, additional, Atallah, Kandace, additional, Banappagari, Sashikanth, additional, Bastani, Niutish, additional, Blackstock, Daniel, additional, Boonyaratanakornkit, Bobby, additional, Carey, Elizabeth, additional, Charlton, Adam, additional, Chaudhuri, Rajoshi, additional, Caringal, Alegria M., additional, Chen, Mingzhong, additional, Chen, Peifeng, additional, Cheng, Wei, additional, Gowetski, Daniel, additional, Gulla, Krishana, additional, Hastings, Erica, additional, Horwitz, Joe, additional, Ivleva, Vera, additional, Kordella, Dan, additional, Kueltzo, Lisa A., additional, Lagler, Sara, additional, Le, Matt, additional, Lee, James, additional, Lei, Paula, additional, Li, Yile, additional, Nagy, Attila, additional, Patel, Aakash, additional, Runsewe, Peyi, additional, Shadrick, Will, additional, Shetty, Shamitha, additional, Wang, Hairong, additional, Webber, Calvin, additional, Vejzagic, Farah, additional, and Yang, Yoo-Jung, additional

Published
2023
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9. Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial

Author

Kibuuka, Hannah, Berkowitz, Nina M, Millard, Monica, Enama, Mary E, Tindikahwa, Allan, Sekiziyivu, Arthur B, Costner, Pamela, Sitar, Sandra, Glover, Deline, Hu, Zonghui, Joshi, Gyan, Stanley, Daphne, Kunchai, Meghan, Eller, Leigh Anne, Bailer, Robert T, Koup, Richard A, Nabel, Gary J, Mascola, John R, Sullivan, Nancy J, Graham, Barney S, Roederer, Mario, Michael, Nelson L, Robb, Merlin L, and Ledgerwood, Julie E

Published
2015
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10. Supplemental Materials for Safety and Immunogenicity of Chimpanzee Adenovirus Vector Ebola Vaccine

Author

Ledgerwood, Julie E., DeZure, Adam D., Stanley, Daphne A., Novik, Laura, Enama, Mary E., Berkowitz, Nina M., Hu, Zonghui, Joshi, Gyan, Ploquin, Aurélie, Sitar, Sandra, Gordon, Ingelise J., Plummer, Sarah A., Holman, LaSonji A., Hendel, Cynthia S., Yamshchikov, Galina, Roman, Francois, Nicosia, Alfredo, Colloca, Stefano, Cortese, Riccardo, Bailer, Robert T., Schwartz, Richard M., Roederer, Mario, Mascola, John R., Koup, Richard A., Sullivan, Nancy J., and Graham, Barney S.

Published
2017

11. Low-Dose Subcutaneous or Intravenous Monoclonal Antibody to Prevent Malaria

Author

Wu, Richard L., primary, Idris, Azza H., additional, Berkowitz, Nina M., additional, Happe, Myra, additional, Gaudinski, Martin R., additional, Buettner, Christian, additional, Strom, Larisa, additional, Awan, Seemal F., additional, Holman, LaSonji A., additional, Mendoza, Floreliz, additional, Gordon, Ingelise J., additional, Hu, Zonghui, additional, Campos Chagas, Andrezza, additional, Wang, Lawrence T., additional, Da Silva Pereira, Lais, additional, Francica, Joseph R., additional, Kisalu, Neville K., additional, Flynn, Barbara J., additional, Shi, Wei, additional, Kong, Wing-Pui, additional, O’Connell, Sarah, additional, Plummer, Sarah H., additional, Beck, Allison, additional, McDermott, Adrian, additional, Narpala, Sandeep R., additional, Serebryannyy, Leonid, additional, Castro, Mike, additional, Silva, Rosa, additional, Imam, Marjaan, additional, Pittman, Iris, additional, Hickman, Somia P., additional, McDougal, Andrew J., additional, Lukoskie, Ashly E., additional, Murphy, Jittawadee R., additional, Gall, Jason G., additional, Carlton, Kevin, additional, Morgan, Patricia, additional, Seo, Ellie, additional, Stein, Judy A., additional, Vazquez, Sandra, additional, Telscher, Shinyi, additional, Capparelli, Edmund V., additional, Coates, Emily E., additional, Mascola, John R., additional, Ledgerwood, Julie E., additional, Dropulic, Lesia K., additional, and Seder, Robert A., additional

Published
2022
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12. Safety and tolerability of AAV8 delivery of a broadly neutralizing antibody in adults living with HIV: a phase 1, dose-escalation trial

Author

Casazza, Joseph P., Cale, Evan M., Narpala, Sandeep, Yamshchikov, Galina V., Coates, Emily E., Hendel, Cynthia S., Novik, Laura, Holman, LaSonji A., Widge, Alicia T., Apte, Preeti, Gordon, Ingelise, Gaudinski, Martin R., Conan-Cibotti, Michelle, Lin, Bob C., Nason, Martha C., Trofymenko, Olga, Telscher, Shinyi, Plummer, Sarah H., Wycuff, Diane, Adams, William C., Pandey, Janardan P., McDermott, Adrian, Roederer, Mario, Sukienik, Avery N., O'Dell, Sijy, Gall, Jason G., Flach, Britta, Terry, Travis L., Choe, Misook, Shi, Wei, Chen, Xuejun, Kaltovich, Florence, Saunders, Kevin O., Stein, Judy A., Doria-Rose, Nicole A., Schwartz, Richard M., Balazs, Alejandro B., Baltimore, David, Nabel, Gary J., Koup, Richard A., Graham, Barney S., Ledgerwood, Julie E., Mascola, John R., Andrews, Charla, Arthur, Anita, Awan, Seemal F., Beck, Allison, Burch, Eugeania, Burgos Florez, Maria C., Berkowitz, Nina M., Boritz, Eli A., Carlton, Kevin, Cartagena, Cora T., Carter, Christina, Chen, Grace L., Costner, Pamela, Cunningham, Jennifer, Douek, Daniel C., Eshun, Aba M., Evans, Catina, Hicks, Renunda, Houser, Katherine V., Jones, Justine, Larkin, Brenda, Le, Lam, Mendoza, Floreliz, Migueles, Stephen, Misasi, John, Nguyen, Thuy A., Ola, Abidemi, Parker, Karen, Pittman, Iris, Requilman, La’ Shawn, Rothwell, Ro Shauna, Schieber, Gretchen L., Saunders, Jamie, Sitar, Sandra, Tran, Colin, Vasilenko, Olga, Waheed, Sana, Wang, Lingshu, Wang, Xiaolin, Whalen, William, Williams, Pernell, Wu, Richard L., and Zephir, Kathy

Subjects
Adult, HIV-1, Humans, HIV Infections, General Medicine, Dependovirus, HIV Antibodies, Antibodies, Neutralizing, General Biochemistry, Genetics and Molecular Biology, Article, Broadly Neutralizing Antibodies
Abstract

Adeno-associated viral vector-mediated transfer of DNA coding for broadly neutralizing anti-HIV antibodies (bnAbs) offers an alternative to attempting to induce protection by vaccination or by repeated infusions of bnAbs. In this study, we administered a recombinant bicistronic adeno-associated virus (AAV8) vector coding for both the light and heavy chains of the potent broadly neutralizing HIV-1 antibody VRC07 (AAV8-VRC07) to eight adults living with HIV. All participants remained on effective anti-retroviral therapy (viral load (VL) 1 μg ml(−1) in three individuals. In four individuals, VRC07 serum concentrations remained stable near maximal concentration for up to 3 years of follow-up. In exploratory analyses, neutralizing activity of in vivo produced VRC07 was similar to that of in vitro produced VRC07. Three of eight participants showed a non-idiotypic anti-drug antibody (ADA) response directed against the Fab portion of VRC07. This ADA response appeared to decrease the production of serum VRC07 in two of these three participants. These data represent a proof of concept that adeno-associated viral vectors can durably produce biologically active, difficult-to-induce bnAbs in vivo, which could add valuable new tools to the fight against infectious diseases.

Published
2022

13. Chimpanzee Adenovirus Vector Ebola Vaccine

Author

Ledgerwood, Julie E., DeZure, Adam D., Stanley, Daphne A., Coates, Emily E., Novik, Laura, Enama, Mary E., Berkowitz, Nina M., Hu, Zonghui, Joshi, Gyan, Ploquin, Aurélie, Sitar, Sandra, Gordon, Ingelise J., Plummer, Sarah A., Holman, LaSonji A., Hendel, Cynthia S., Yamshchikov, Galina, Roman, Francois, Nicosia, Alfredo, Colloca, Stefano, Cortese, Riccardo, Bailer, Robert T., Schwartz, Richard M., Roederer, Mario, Mascola, John R., Koup, Richard A., Sullivan, Nancy J., and Graham, Barney S.

Published
2017
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14. An influenza hemagglutinin stem nanoparticle vaccine induces cross-group 1 neutralizing antibodies in healthy adults.

Author

Widge, Alicia T., Hofstetter, Amelia R., Houser, Katherine V., Awan, Seemal F., Chen, Grace L., Burgos Florez, Maria C., Berkowitz, Nina M., Mendoza, Floreliz, Hendel, Cynthia S., Holman, LaSonji A., Gordon, Ingelise J., Apte, Preeti, Liang, C. Jason, Gaudinski, Martin R., Coates, Emily E., Strom, Larisa, Wycuff, Diane, Vazquez, Sandra, Stein, Judy A., and Gall, Jason G.

Subjects
IMMUNOGLOBULINS, NANOPARTICLES, IMMUNOLOGIC memory, HEMAGGLUTININ, VACCINE trials, SUMATRIPTAN, INFLUENZA vaccines
Abstract

Influenza vaccines could be improved by platforms inducing cross-reactive immunity. Immunodominance of the influenza hemagglutinin (HA) head in currently licensed vaccines impedes induction of cross-reactive neutralizing stem-directed antibodies. A vaccine without the variable HA head domain has the potential to focus the immune response on the conserved HA stem. This first-in-human dose-escalation open-label phase 1 clinical trial (NCT03814720) tested an HA stabilized stem ferritin nanoparticle vaccine (H1ssF) based on the H1 HA stem of A/New Caledonia/20/1999. Fifty-two healthy adults aged 18 to 70 years old enrolled to receive either 20 μg of H1ssF once (n = 5) or 60 μg of H1ssF twice (n = 47) with a prime-boost interval of 16 weeks. Thirty-five (74%) 60-μg dose participants received the boost, whereas 11 (23%) boost vaccinations were missed because of public health restrictions in the early stages of the COVID-19 pandemic. The primary objective of this trial was to evaluate the safety and tolerability of H1ssF, and the secondary objective was to evaluate antibody responses after vaccination. H1ssF was safe and well tolerated, with mild solicited local and systemic reactogenicity. The most common symptoms included pain or tenderness at the injection site (n = 10, 19%), headache (n = 10, 19%), and malaise (n = 6, 12%). We found that H1ssF elicited cross-reactive neutralizing antibodies against the conserved HA stem of group 1 influenza viruses, despite previous H1 subtype head-specific immunity. These responses were durable, with neutralizing antibodies observed more than 1 year after vaccination. Our results support this platform as a step forward in the development of a universal influenza vaccine. Fighting flu: A major goal for influenza vaccines is to elicit broadly reactive immune responses that can protect against many strains of the virus. Widge et al. and Andrews et al. report results of a phase 1 clinical trial testing a vaccine that may get closer to this goal. Widge et al. demonstrated that immunization with one or two doses of an H1 hemagglutinin stabilized stem nanoparticle (H1ssF) vaccine was safe in recipients and elicited durable neutralizing antibody responses. Andrews et al. found that memory B cell responses elicited by H1ssF vaccination were broadly cross-reactive and targeted two conserved epitopes on the H1 stem. Together, these studies highlight the potential of H1ssF and similar stem-only immunogens as influenza vaccines. —CM [ABSTRACT FROM AUTHOR]

Published
2023
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15. Optimization of the CIS43LS Malarial Monoclonal Antibody and Protection Against Malaria

Author

Lyke, Kirsten E., primary, Berry, Andrea A., additional, Mason, Kaitlin, additional, Idris, Azza A., additional, O'Callahan, Mark, additional, Happe, Myra, additional, Strom, Larisa, additional, Berkowitz, Nina M., additional, Guech, Mercy, additional, Hu, Zonghui, additional, Castro, Mike, additional, Basappa, Manjula, additional, Wang, Lu, additional, Naqvi, Muhammed, additional, Low, Kwang, additional, Holman, LaSonji A., additional, Mendoza, Floreliz, additional, Gordon, Ingelize J., additional, Plummer, Sarah H., additional, Trofymenko, Olga, additional, Strauss, Kathleen S., additional, Joshi, Sudhaunshu, additional, Shrestha, Biraj, additional, Adams, Matthew, additional, Campos Chagas, Andrezza, additional, Murphy, Jittawadee R., additional, Stein, Judy A., additional, Hickman, Somia P., additional, McDougal, Andrew J., additional, Lin, Bob, additional, Narparla, Sandeep, additional, Vazquez, Sandra, additional, Serebryannyy, Leonid, additional, McDermott, Adrian, additional, Gaudinski, Martin R., additional, Capparelli, Edmund V., additional, Coates, Emily E., additional, Wu, Richard L., additional, Ledgerwood, Julie E., additional, Dropulic, Lesia K., additional, and Seder, Robert A., additional

Published
2022
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16. Safety, tolerability, and immunogenicity of the respiratory syncytial virus prefusion F subunit vaccine DS-Cav1: a phase 1, randomised, open-label, dose-escalation clinical trial

Author

Ruckwardt, Tracy J, primary, Morabito, Kaitlyn M, additional, Phung, Emily, additional, Crank, Michelle C, additional, Costner, Pamela J, additional, Holman, LaSonji A, additional, Chang, Lauren A, additional, Hickman, Somia P, additional, Berkowitz, Nina M, additional, Gordon, Ingelise J, additional, Yamshchikov, Galina V, additional, Gaudinski, Martin R, additional, Lin, Bob, additional, Bailer, Robert, additional, Chen, Man, additional, Ortega-Villa, Ana M, additional, Nguyen, Thuy, additional, Kumar, Azad, additional, Schwartz, Richard M, additional, Kueltzo, Lisa A, additional, Stein, Judith A, additional, Carlton, Kevin, additional, Gall, Jason G, additional, Nason, Martha C, additional, Mascola, John R, additional, Chen, Grace, additional, Graham, Barney S, additional, Arthur, Anita, additional, Cunningham, Jennifer, additional, Eshun, Aba, additional, Larkin, Brenda, additional, Mendoza, Floreliz, additional, Novik, Laura, additional, Saunders, Jamie, additional, Wang, Xiaolin, additional, Whalen, William, additional, Carter, Cristina, additional, Hendel, Cynthia Starr, additional, Plummer, Sarah, additional, Ola, Abidemi, additional, Widge, Alicia, additional, Burgos Florez, Maria C, additional, Le, Lam, additional, Pittman, Iris, additional, Rothwell, Ro Shauna S, additional, Trofymenko, Olga, additional, Vasilenko, Olga, additional, Apte, Preeti, additional, Hicks, Renunda, additional, Cartagena, Cora Trelles, additional, Williams, Pernell, additional, Requilman, LaShawn, additional, Tran, Colin, additional, Bai, Shufeng, additional, Carey, Elizabeth, additional, Chamberlain, Amy L, additional, Chang, Ya-chen, additional, Chen, Mingzhong, additional, Chen, Peifeng, additional, Cooper, Jon, additional, Fridley, Colleen, additional, Ghosh, Mridul, additional, Gollapudi, Deepika, additional, Holland-Linn, Janel, additional, Horwitz, Joe, additional, Hussain, Althaf, additional, Ivleva, Vera, additional, Kaltovich, Florence, additional, Leach, Kristin, additional, Lee, Christopher, additional, Liu, Amy, additional, Liu, Xun, additional, Manceva, Slobodanka, additional, Menon, Amritha, additional, Nagy, Attila, additional, O'Connell, Sarah, additional, Ragunathan, Rahul, additional, Walters, Jennifer, additional, and Zhao, Zhong, additional

Published
2021
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17. A Monoclonal Antibody for Malaria Prevention

Author

Gaudinski, Martin R., primary, Berkowitz, Nina M., additional, Idris, Azza H., additional, Coates, Emily E., additional, Holman, LaSonji A., additional, Mendoza, Floreliz, additional, Gordon, Ingelise J., additional, Plummer, Sarah H., additional, Trofymenko, Olga, additional, Hu, Zonghui, additional, Campos Chagas, Andrezza, additional, O’Connell, Sarah, additional, Basappa, Manjula, additional, Douek, Naomi, additional, Narpala, Sandeep R., additional, Barry, Christopher R., additional, Widge, Alicia T., additional, Hicks, Renunda, additional, Awan, Seemal F., additional, Wu, Richard L., additional, Hickman, Somia, additional, Wycuff, Diane, additional, Stein, Judy A., additional, Case, Christopher, additional, Evans, Brian P., additional, Carlton, Kevin, additional, Gall, Jason G., additional, Vazquez, Sandra, additional, Flach, Britta, additional, Chen, Grace L., additional, Francica, Joseph R., additional, Flynn, Barbara J., additional, Kisalu, Neville K., additional, Capparelli, Edmund V., additional, McDermott, Adrian, additional, Mascola, John R., additional, Ledgerwood, Julie E., additional, and Seder, Robert A., additional

Published
2021
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18. Vaccination with prefusion-stabilized respiratory syncytial virus fusion protein induces genetically and antigenically diverse antibody responses

Author

Mukhamedova, Maryam, primary, Wrapp, Daniel, additional, Shen, Chen-Hsiang, additional, Gilman, Morgan S.A., additional, Ruckwardt, Tracy J., additional, Schramm, Chaim A., additional, Ault, Larissa, additional, Chang, Lauren, additional, Derrien-Colemyn, Alexandrine, additional, Lucas, Sarah A.M., additional, Ransier, Amy, additional, Darko, Samuel, additional, Phung, Emily, additional, Wang, Lingshu, additional, Zhang, Yi, additional, Rush, Scott A., additional, Madan, Bharat, additional, Stewart-Jones, Guillaume B.E., additional, Costner, Pamela J., additional, Holman, LaSonji A., additional, Hickman, Somia P., additional, Berkowitz, Nina M., additional, Doria-Rose, Nicole A., additional, Morabito, Kaitlyn M., additional, DeKosky, Brandon J., additional, Gaudinski, Martin R., additional, Chen, Grace L., additional, Crank, Michelle C., additional, Misasi, John, additional, Sullivan, Nancy J., additional, Douek, Daniel C., additional, Kwong, Peter D., additional, Graham, Barney S., additional, McLellan, Jason S., additional, and Mascola, John R., additional

Published
2021
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19. Molecular Dissection Of Human Antibody Responses Following Prefusion-Stabilized RSV F Vaccination

Author

Mukhamedova, Maryam, primary, Wrapp, Daniel, additional, Shen, Chen-Hsiang, additional, Gilman, Morgan S.A., additional, Ruckwardt, Tracy, additional, Schramm, Chaim A., additional, Ault, Larissa, additional, Chang, Lauren, additional, Derrien-Colemyn, Alexandrine, additional, Lucas, Sarah A.M., additional, Ransier, Amy, additional, Darko, Samuel, additional, Phung, Emily, additional, Wang, Lingshu, additional, Zhang, Yi, additional, Rush, Scott A., additional, Madan, Bharat, additional, Stewart-Jones, Guillaume B. E., additional, Costner, Pamela J., additional, Holman, LaSonji A., additional, Hickman, Somia P., additional, Berkowitz, Nina M., additional, Doria-Rose, Nicole, additional, Morabito, Kaitlyn M., additional, DeKosky, Brandon J., additional, Gaudinski, Martin R., additional, Chen, Grace L., additional, Crank, Michelle C., additional, Misasi, John, additional, Sullivan, Nancy J., additional, Douek, Daniel C., additional, Kwong, Peter D., additional, Graham, Barney S., additional, McLellan, Jason S., additional, and Mascola, John, additional

Published
2020
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20. Chimpanzee Adenovirus Vector Ebola Vaccine - Preliminary Report

Author

Ledgerwood, Julie E, Dezure, Adam D, Stanley, Daphne A, Novik, Laura, Enama, Mary E, Berkowitz, Nina M, Hu, Zonghui, Joshi, Gyan, Ploquin, Aurélie, Sitar, Sandra, Gordon, Ingelise J, Plummer, Sarah A, Holman, LaSonji A, Hendel, Cynthia S, Yamshchikov, Galina, Roman, Francois, Colloca, Stefano, Cortese, Riccardo, Bailer, Robert T, Schwartz, Richard M, Roederer, Mario, Mascola, John R, Koup, Richard A, Sullivan, Nancy J, Graham, Barney S., NICOSIA, Alfredo, Ledgerwood, Julie E, Dezure, Adam D, Stanley, Daphne A, Novik, Laura, Enama, Mary E, Berkowitz, Nina M, Hu, Zonghui, Joshi, Gyan, Ploquin, Aurélie, Sitar, Sandra, Gordon, Ingelise J, Plummer, Sarah A, Holman, LaSonji A, Hendel, Cynthia S, Yamshchikov, Galina, Roman, Francoi, Nicosia, Alfredo, Colloca, Stefano, Cortese, Riccardo, Bailer, Robert T, Schwartz, Richard M, Roederer, Mario, Mascola, John R, Koup, Richard A, Sullivan, Nancy J, and Graham, Barney S.

Abstract

Background The unprecedented 2014 epidemic of Ebola virus disease (EVD) has prompted an international response to accelerate the availability of a preventive vaccine. A replication-defective recombinant chimpanzee adenovirus type 3-vectored ebolavirus vaccine (cAd3-EBO), encoding the glycoprotein from Zaire and Sudan species that offers protection in the nonhuman primate model, was rapidly advanced into phase 1 clinical evaluation. Methods We conducted a phase 1, dose-escalation, open-label trial of cAd3-EBO. Twenty healthy adults, in sequentially enrolled groups of 10 each, received vaccination intramuscularly in doses of 2×10(10) particle units or 2×10(11) particle units. Primary and secondary end points related to safety and immunogenicity were assessed throughout the first 4 weeks after vaccination. Results In this small study, no safety concerns were identified; however, transient fever developed within 1 day after vaccination in two participants who had received the 2×10(11) particle-unit dose. Glycoprotein-specific antibodies were induced in all 20 participants; the titers were of greater magnitude in the group that received the 2×10(11) particle-unit dose than in the group that received the 2×10(10) particle-unit dose (geometric mean titer against the Zaire antigen, 2037 vs. 331; P=0.001). Glycoprotein-specific T-cell responses were more frequent among those who received the 2x10(11) particle-unit dose than among those who received the 2×10(10) particle-unit dose, with a CD4 response in 10 of 10 participants versus 3 of 10 participants (P=0.004) and a CD8 response in 7 of 10 participants versus 2 of 10 participants (P=0.07). Conclusions Reactogenicity and immune responses to cAd3-EBO vaccine were dose-dependent. At the 2×10(11) particle-unit dose, glycoprotein Zaire-specific antibody responses were in the range reported to be associated with vaccine-induced protective immunity in challenge studies involving nonhuman primates. Clinical trials assessing cAd3-EBO are ongoing. (Funded by the Intramural Research Program of the National Institutes of Health; VRC 207 ClinicalTrials.gov number, NCT02231866 .).

Published
2014

21. A proof of concept for structure-based vaccine design targeting RSV in humans.

Author

Crank, Michelle C., Ruckwardt, Tracy J., Chen, Man, Morabito, Kaitlyn M., Phung, Emily, Costner, Pamela J., Holman, LaSonji A., Hickman, Somia P., Berkowitz, Nina M., Gordon, Ingelise J., Yamshchikov, Galina V., Gaudinski, Martin R., Kumar, Azad, Chang, Lauren A., Moin, Syed M., Hill, Juliane P., DiPiazza, Anthony T., Schwartz, Richard M., Kueltzo, Lisa, and Cooper, Jonathan W.

Published
2019
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23. Durability of mRNA-1273 vaccine-induced antibodies against SARS-CoV-2 variants.

Author

Pegu A, O'Connell SE, Schmidt SD, O'Dell S, Talana CA, Lai L, Albert J, Anderson E, Bennett H, Corbett KS, Flach B, Jackson L, Leav B, Ledgerwood JE, Luke CJ, Makowski M, Nason MC, Roberts PC, Roederer M, Rebolledo PA, Rostad CA, Rouphael NG, Shi W, Wang L, Widge AT, Yang ES, Beigel JH, Graham BS, Mascola JR, Suthar MS, McDermott AB, Doria-Rose NA, Arega J, Beigel JH, Buchanan W, Elsafy M, Hoang B, Lampley R, Kolhekar A, Koo H, Luke C, Makhene M, Nayak S, Pikaart-Tautges R, Roberts PC, Russell J, Sindall E, Albert J, Kunwar P, Makowski M, Anderson EJ, Bechnak A, Bower M, Camacho-Gonzalez AF, Collins M, Drobeniuc A, Edara VV, Edupuganti S, Floyd K, Gibson T, Ackerley CMG, Johnson B, Kamidani S, Kao C, Kelley C, Lai L, Macenczak H, McCullough MP, Peters E, Phadke VK, Rebolledo PA, Rostad CA, Rouphael N, Scherer E, Sherman A, Stephens K, Suthar MS, Teherani M, Traenkner J, Winston J, Yildirim I, Barr L, Benoit J, Carste B, Choe J, Dunstan M, Erolin R, Ffitch J, Fields C, Jackson LA, Kiniry E, Lasicka S, Lee S, Nguyen M, Pimienta S, Suyehira J, Witte M, Bennett H, Altaras NE, Carfi A, Hurley M, Leav B, Pajon R, Sun W, Zaks T, Coler RN, Larsen SE, Neuzil KM, Lindesmith LC, Martinez DR, Munt J, Mallory M, Edwards C, Baric RS, Berkowitz NM, Boritz EA, Carlton K, Corbett KS, Costner P, Creanga A, Doria-Rose NA, Douek DC, Flach B, Gaudinski M, Gordon I, Graham BS, Holman L, Ledgerwood JE, Leung K, Lin BC, Louder MK, Mascola JR, McDermott AB, Morabito KM, Novik L, O'Connell S, O'Dell S, Padilla M, Pegu A, Schmidt SD, Shi W, Swanson PA 2nd, Talana CA, Wang L, Widge AT, Yang ES, Zhang Y, Chappell JD, Denison MR, Hughes T, Lu X, Pruijssers AJ, Stevens LJ, Posavad CM, Gale M Jr, Menachery V, and Shi PY

Subjects
2019-nCoV Vaccine mRNA-1273, Adolescent, Adult, Aged, Antibodies, Neutralizing immunology, Antibodies, Viral immunology, COVID-19 prevention & control, COVID-19 Vaccines administration & dosage, Cross Reactions, Humans, Immune Evasion, Immunization, Secondary, Immunogenicity, Vaccine, Middle Aged, Time Factors, Young Adult, Antibodies, Neutralizing blood, Antibodies, Viral blood, COVID-19 Vaccines immunology, SARS-CoV-2 immunology
Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mutations may diminish vaccine-induced protective immune responses, particularly as antibody titers wane over time. Here, we assess the effect of SARS-CoV-2 variants B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.429 (Epsilon), B.1.526 (Iota), and B.1.617.2 (Delta) on binding, neutralizing, and angiotensin-converting enzyme 2 (ACE2)–competing antibodies elicited by the messenger RNA (mRNA) vaccine mRNA-1273 over 7 months. Cross-reactive neutralizing responses were rare after a single dose. At the peak of response to the second vaccine dose, all individuals had responses to all variants. Binding and functional antibodies against variants persisted in most subjects, albeit at low levels, for 6 months after the primary series of the mRNA-1273 vaccine. Across all assays, B.1.351 had the lowest antibody recognition. These data complement ongoing studies to inform the potential need for additional boost vaccinations.

Published
2021
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