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1. Infant rhesus macaques immunized against SARS-CoV-2 are protected against heterologous virus challenge one year later

Author

Milligan, Emma C, Olstad, Katherine, Williams, Caitlin A, Mallory, Michael, Cano, Patricio, Cross, Kaitlyn A, Munt, Jennifer E, Garrido, Carolina, Lindesmith, Lisa, Watanabe, Jennifer, Usachenko, Jodie L, Hopkins, Lincoln, Immareddy, Ramya, Lakshmanappa, Yashavanth Shaan, Elizaldi, Sonny R, Roh, Jamin W, Sammak, Rebecca L, Pollard, Rachel E, Yee, JoAnn L, Herbek, Savannah, Scobey, Trevor, Miehlke, Dieter, Fouda, Genevieve, Ferrari, Guido, Gao, Hongmei, Shen, Xiaoying, Kozlowski, Pamela A, Montefiori, David, Hudgens, Michael G, Edwards, Darin K, Carfi, Andrea, Corbett, Kizzmekia S, Graham, Barney S, Fox, Christopher B, Tomai, Mark, Iyer, Smita S, Baric, Ralph, Reader, Rachel, Dittmer, Dirk P, Van Rompay, Koen KA, Permar, Sallie R, and De Paris, Kristina

Subjects
Immunization, Emerging Infectious Diseases, Infectious Diseases, Prevention, Biodefense, Vaccine Related, Pneumonia, Pneumonia & Influenza, Lung, Biotechnology, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Prevention of disease and conditions, and promotion of well-being, 3.4 Vaccines, Infection, Good Health and Well Being, Animals, Humans, Infant, SARS-CoV-2, COVID-19 Vaccines, Macaca mulatta, COVID-19, Viral Vaccines, BNT162 Vaccine, Antibodies, Viral, Antibodies, Neutralizing, Biological Sciences, Medical and Health Sciences
Abstract

The U.S. Food and Drug Administration only gave emergency use authorization of the BNT162b2 and mRNA-1273 SARS-CoV-2 vaccines for infants 6 months and older in June 2022. Yet questions regarding the durability of vaccine efficacy, especially against emerging variants, in this age group remain. We demonstrated previously that a two-dose regimen of stabilized prefusion Washington SARS-CoV-2 S-2P spike (S) protein encoded by mRNA encapsulated in lipid nanoparticles (mRNA-LNP) or purified S-2P mixed with 3M-052, a synthetic Toll-like receptor (TLR) 7/8 agonist, in a squalene emulsion (Protein+3M-052-SE) was safe and immunogenic in infant rhesus macaques. Here, we demonstrate that broadly neutralizing and spike-binding antibodies against variants of concern (VOCs), as well as T cell responses, persisted for 12 months. At 1 year, corresponding to human toddler age, we challenged vaccinated rhesus macaques and age-matched nonvaccinated controls intranasally and intratracheally with a high dose of heterologous SARS-CoV-2 B.1.617.2 (Delta). Seven of eight control rhesus macaques exhibited severe interstitial pneumonia and high virus replication in the upper and lower respiratory tract. In contrast, vaccinated rhesus macaques had faster viral clearance with mild to no pneumonia. Neutralizing and binding antibody responses to the B.1.617.2 variant at the day of challenge correlated with lung pathology and reduced virus replication. Overall, the Protein+3M-052-SE vaccine provided superior protection to the mRNA-LNP vaccine, emphasizing opportunities for optimization of current vaccine platforms. The observed efficacy of both vaccines 1 year after vaccination supports the implementation of an early-life SARS-CoV-2 vaccine.

Published
2023

2. Self-assembling SARS-CoV-2 spike-HBsAg nanoparticles elicit potent and durable neutralizing antibody responses via genetic delivery

Author

Liu, Cuiping, Wang, Lingshu, Merriam, Jonah S., Shi, Wei, Yang, Eun Sung, Zhang, Yi, Chen, Man, Kong, Wing-Pui, Cheng, Cheng, Tsybovsky, Yaroslav, Stephens, Tyler, Verardi, Raffaello, Leung, Kwanyee, Stein, Cody, Olia, Adam S., Harris, Darcy R., Choe, Misook, Zhang, Baoshan, Graham, Barney S., Kwong, Peter D., Koup, Richard A., Pegu, Amarendra, and Mascola, John R.

Published
2023
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3. Nanoparticle display of prefusion coronavirus spike elicits S1-focused cross-reactive antibody response against diverse coronavirus subgenera

Author

Hutchinson, Geoffrey B., Abiona, Olubukola M., Ziwawo, Cynthia T., Werner, Anne P., Ellis, Daniel, Tsybovsky, Yaroslav, Leist, Sarah R., Palandjian, Charis, West, Ande, Fritch, Ethan J., Wang, Nianshuang, Wrapp, Daniel, Boyoglu-Barnum, Seyhan, Ueda, George, Baker, David, Kanekiyo, Masaru, McLellan, Jason S., Baric, Ralph S., King, Neil P., Graham, Barney S., and Corbett-Helaire, Kizzmekia S.

Published
2023
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6. Protective human monoclonal antibodies target conserved sites of vulnerability on the underside of influenza virus neuraminidase

Author

Lederhofer, Julia, Tsybovsky, Yaroslav, Nguyen, Lam, Raab, Julie E., Creanga, Adrian, Stephens, Tyler, Gillespie, Rebecca A., Syeda, Hubza Z., Fisher, Brian E., Skertic, Michelle, Yap, Christina, Schaub, Andrew J., Rawi, Reda, Kwong, Peter D., Graham, Barney S., McDermott, Adrian B., Andrews, Sarah F., King, Neil P., and Kanekiyo, Masaru

Published
2024
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7. Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase

Author

El Sahly, Hana M, Baden, Lindsey R, Essink, Brandon, Doblecki-Lewis, Susanne, Martin, Judith M, Anderson, Evan J, Campbell, Thomas B, Clark, Jesse, Jackson, Lisa A, Fichtenbaum, Carl J, Zervos, Marcus, Rankin, Bruce, Eder, Frank, Feldman, Gregory, Kennelly, Christina, Han-Conrad, Laurie, Levin, Michael, Neuzil, Kathleen M, Corey, Lawrence, Gilbert, Peter, Janes, Holly, Follmann, Dean, Marovich, Mary, Polakowski, Laura, Mascola, John R, Ledgerwood, Julie E, Graham, Barney S, August, Allison, Clouting, Heather, Deng, Weiping, Han, Shu, Leav, Brett, Manzo, Deb, Pajon, Rolando, Schödel, Florian, Tomassini, Joanne E, Zhou, Honghong, and Miller, Jacqueline

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Infectious Diseases, Emerging Infectious Diseases, Clinical Research, Genetics, Vaccine Related, Prevention, Lung, Immunization, Biodefense, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, 2019-nCoV Vaccine mRNA-1273, Adolescent, Adult, Aged, COVID-19, COVID-19 Vaccines, Follow-Up Studies, Humans, Immunization, Secondary, Immunogenicity, Vaccine, Incidence, Intention to Treat Analysis, Male, Middle Aged, Patient Acuity, Single-Blind Method, Treatment Outcome, Young Adult, COVE Study Group, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundAt interim analysis in a phase 3, observer-blinded, placebo-controlled clinical trial, the mRNA-1273 vaccine showed 94.1% efficacy in preventing coronavirus disease 2019 (Covid-19). After emergency use of the vaccine was authorized, the protocol was amended to include an open-label phase. Final analyses of efficacy and safety data from the blinded phase of the trial are reported.MethodsWe enrolled volunteers who were at high risk for Covid-19 or its complications; participants were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo, 28 days apart, at 99 centers across the United States. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The data cutoff date was March 26, 2021.ResultsThe trial enrolled 30,415 participants; 15,209 were assigned to receive the mRNA-1273 vaccine, and 15,206 to receive placebo. More than 96% of participants received both injections, 2.3% had evidence of SARS-CoV-2 infection at baseline, and the median follow-up was 5.3 months in the blinded phase. Vaccine efficacy in preventing Covid-19 illness was 93.2% (95% confidence interval [CI], 91.0 to 94.8), with 55 confirmed cases in the mRNA-1273 group (9.6 per 1000 person-years; 95% CI, 7.2 to 12.5) and 744 in the placebo group (136.6 per 1000 person-years; 95% CI, 127.0 to 146.8). The efficacy in preventing severe disease was 98.2% (95% CI, 92.8 to 99.6), with 2 cases in the mRNA-1273 group and 106 in the placebo group, and the efficacy in preventing asymptomatic infection starting 14 days after the second injection was 63.0% (95% CI, 56.6 to 68.5), with 214 cases in the mRNA-1273 group and 498 in the placebo group. Vaccine efficacy was consistent across ethnic and racial groups, age groups, and participants with coexisting conditions. No safety concerns were identified.ConclusionsThe mRNA-1273 vaccine continued to be efficacious in preventing Covid-19 illness and severe disease at more than 5 months, with an acceptable safety profile, and protection against asymptomatic infection was observed. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.).

Published
2021

8. Antibody levels against respiratory syncytial virus fusion protein conformations and lack of association with life-threatening infection in previously healthy infants

Author

Bonnin, Florencia A., Talarico, Laura B., Ferolla, Fausto M., Acosta, Patricio L., Phung, Emily, Kumar, Azad, Toledano, Analía, Caratozzolo, Ana, Neira, Pablo, Mascardi, Normando, Satragno, Daniela, Contrini, María M., Graham, Barney S., Ruckwardt, Tracy J., and López, Eduardo L.

Published
2024
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10. Refined semi-lethal aerosol H5N1 influenza model in cynomolgus macaques for evaluation of medical countermeasures

Author

Kanekiyo, Masaru, Gillespie, Rebecca A., Midgett, Morgan, O’Malley, Katherine J., Williams, Connor, Moin, Syed M., Wallace, Megan, Treaster, Luke, Cooper, Kristine, Syeda, Hubza, Kettenburg, Gwenddolen, Rannulu, Hasala, Schmer, Tabitha, Ortiz, Lucia, Da Silva Castanha, Priscila, Corry, Jacqueline, Xia, Mengying, Olsen, Emily, Perez, Daniel, Yun, Gabin, Graham, Barney S., Barratt-Boyes, Simon M., and Reed, Douglas S.

Published
2023
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11. Multivalent antigen display on nanoparticle immunogens increases B cell clonotype diversity and neutralization breadth to pneumoviruses

Author

Ols, Sebastian, Lenart, Klara, Arcoverde Cerveira, Rodrigo, Miranda, Marcos C., Brunette, Natalie, Kochmann, Jana, Corcoran, Martin, Skotheim, Rebecca, Philomin, Annika, Cagigi, Alberto, Fiala, Brooke, Wrenn, Samuel, Marcandalli, Jessica, Hellgren, Fredrika, Thompson, Elizabeth A., Lin, Ang, Gegenfurtner, Florian, Kumar, Azad, Chen, Man, Phad, Ganesh E., Graham, Barney S., Perez, Laurent, Borst, Andrew J., Karlsson Hedestam, Gunilla B., Ruckwardt, Tracy J., King, Neil P., and Loré, Karin

Published
2023
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12. Tailored design of protein nanoparticle scaffolds for multivalent presentation of viral glycoprotein antigens.

Author

Ueda, George, Antanasijevic, Aleksandar, Fallas, Jorge A, Sheffler, William, Copps, Jeffrey, Ellis, Daniel, Hutchinson, Geoffrey B, Moyer, Adam, Yasmeen, Anila, Tsybovsky, Yaroslav, Park, Young-Jun, Bick, Matthew J, Sankaran, Banumathi, Gillespie, Rebecca A, Brouwer, Philip Jm, Zwart, Peter H, Veesler, David, Kanekiyo, Masaru, Graham, Barney S, Sanders, Rogier W, Moore, John P, Klasse, Per Johan, Ward, Andrew B, King, Neil P, and Baker, David

Subjects
Humans, Glycoproteins, Influenza Vaccines, Antigens, Viral, Cryoelectron Microscopy, Vaccination, Nanoparticles, Immunity, Humoral, B lymphocytes, BL21, E. coli, HEK293F, Lemo21, computational biology, human, immunology, inflammation, systems biology, virus, Antigens, Viral, Immunity, Humoral, Biochemistry and Cell Biology
Abstract

Multivalent presentation of viral glycoproteins can substantially increase the elicitation of antigen-specific antibodies. To enable a new generation of anti-viral vaccines, we designed self-assembling protein nanoparticles with geometries tailored to present the ectodomains of influenza, HIV, and RSV viral glycoprotein trimers. We first de novo designed trimers tailored for antigen fusion, featuring N-terminal helices positioned to match the C termini of the viral glycoproteins. Trimers that experimentally adopted their designed configurations were incorporated as components of tetrahedral, octahedral, and icosahedral nanoparticles, which were characterized by cryo-electron microscopy and assessed for their ability to present viral glycoproteins. Electron microscopy and antibody binding experiments demonstrated that the designed nanoparticles presented antigenically intact prefusion HIV-1 Env, influenza hemagglutinin, and RSV F trimers in the predicted geometries. This work demonstrates that antigen-displaying protein nanoparticles can be designed from scratch, and provides a systematic way to investigate the influence of antigen presentation geometry on the immune response to vaccination.

Published
2020

13. Safety, Tolerability, and Pharmacokinetics of the Broadly Neutralizing Human Immunodeficiency Virus (HIV)-1 Monoclonal Antibody VRC01 in HIV-Exposed Newborn Infants

Author

Cunningham, Coleen K, McFarland, Elizabeth J, Morrison, R Leavitt, Capparelli, Edmund V, Safrit, Jeffrey T, Mofenson, Lynne M, Mathieson, Bonnie, Valentine, Megan E, Perlowski, Charlotte, Smith, Betsy, Hazra, Rohan, Purdue, Lynette, Muresan, Petronella, Harding, Paul A, Mbengeranwa, Tapiwa, Robinson, Lisa-Gaye, Wiznia, Andrew, Theron, Gerhard, Lin, Bob, Bailer, Robert T, Mascola, John R, Graham, Barney S, Aldrovandi, Grace, Bone, Frederic, Dayton, Dale, Johnston, Benjamin, Morgan, Patricia, Myers, Kathryn, Tobin, Nicole, Zimmer, Bonnie, Rossouw, Magdel, Rossouw, Lindie, Louw, Jeanne, Dobroszycki, Joanna, Burey, Marlene, Auguste, Raphaelle, Graham, Kathleen K, Major-Wilson, Hanna, Mhembere, Tsungai, Maturure, Sukunena, Bwakura-Dangarembizi, Mutsa, Barr, Emily, Dunn, Jennifer, Glenny, Carrie, Chambers, Carrie, Baig, Mahboobullah Mirza, Purswani, Murli, Deville, Jaime G, Nielsen-Saines, Karin, Shin, Christina, Carter, Michele F, Chahroudi, Ann, Ahonen, Alexis, Badell, Martina, Chakraborty, Rana, Agwu, Allison, Golden, W Christopher, Anderson, Thuy, Collinson-Streng, Aleisha, Diaz-Velasco, Rodrigo, Rosario, Nicolas, Pérez, Elvia, Marrero, Wanda I, Febo, Irma, Santos, Ruth, and Zorrilla, Carmen D

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Infectious Diseases, Prevention, Perinatal Period - Conditions Originating in Perinatal Period, Pediatric AIDS, HIV/AIDS, Pediatric, Clinical Research, Immunization, Vaccine Related, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Reproductive health and childbirth, Good Health and Well Being, Africa, Antibodies, Monoclonal, Broadly Neutralizing Antibodies, Female, HIV Antibodies, HIV Infections, HIV-1, Humans, Infant, Newborn, Infectious Disease Transmission, Vertical, Injections, Subcutaneous, Linear Models, Male, United States, broadly neutralizing antibodies, mother-to-child transmission of HIV, neonates, VRC01, IMPAACT P1112 team, Biological Sciences, Medical and Health Sciences, Microbiology, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundAlthough mother-to-child human immunodeficiency virus (HIV) transmission has dramatically decreased with maternal antiretroviral therapy, breast milk transmission accounts for most of the 180 000 new infant HIV infections annually. Broadly neutralizing antibodies (bNAb) may further reduce transmission.MethodsA Phase 1 safety and pharmacokinetic study was conducted: a single subcutaneous (SC) dose of 20 or 40 mg/kg (Dose Groups 1 and 2, respectively) of the bNAb VRC01 was administered to HIV-exposed infants soon after birth. Breastfeeding infants (Dose Group 3) received 40 mg/kg SC VRC01 after birth and then 20 mg/kg/dose SC monthly. All infants received appropriate antiretroviral prophylaxis.ResultsForty infants were enrolled (21 in the United States, 19 in Africa). Subcutaneous VRC01 was safe and well tolerated with only mild-to-moderate local reactions, primarily erythema, which rapidly resolved. For multiple-dose infants, local reactions decreased with subsequent injections. VRC01 was rapidly absorbed after administration, with peak concentrations 1-6 days postdose. The 40 mg/kg dose resulted in 13 of 14 infants achieving the serum 50 micrograms (mcg)/mL target at day 28. Dose Group 3 infants maintained concentrations greater than 50 mcg/mL throughout breastfeeding.ConclusionsSubcutaneous VRC01 as single or multiple doses is safe and well tolerated in very young infants and is suitable for further study to prevent HIV transmission in infants.

Published
2020

14. DNA vaccination before conception protects Zika virus–exposed pregnant macaques against prolonged viremia and improves fetal outcomes

Author

Van Rompay, Koen KA, Keesler, Rebekah I, Ardeshir, Amir, Watanabe, Jennifer, Usachenko, Jodie, Singapuri, Anil, Cruzen, Christina, Bliss-Moreau, Eliza, Murphy, Ashley M, Yee, JoAnn L, Webster, Helen, Dennis, Maria, Singh, Tulika, Heimsath, Holly, Lemos, Danilo, Stuart, Jackson, Morabito, Kaitlyn M, Foreman, Bryant M, Burgomaster, Katherine E, Noe, Amy T, Dowd, Kimberly A, Ball, Erin, Woolard, Kevin, Presicce, Pietro, Kallapur, Suhas G, Permar, Sallie R, Foulds, Kathryn E, Coffey, Lark L, Pierson, Theodore C, and Graham, Barney S

Subjects
Reproductive Medicine, Medical Microbiology, Biomedical and Clinical Sciences, Pediatric Research Initiative, Immunization, Pediatric, Infectious Diseases, Conditions Affecting the Embryonic and Fetal Periods, Biotechnology, Vaccine Related, Prevention, Perinatal Period - Conditions Originating in Perinatal Period, 3.4 Vaccines, Prevention of disease and conditions, and promotion of well-being, Reproductive health and childbirth, Infection, Good Health and Well Being, Animals, Antibodies, Neutralizing, Female, Macaca mulatta, Pregnancy, Pregnancy Complications, Infectious, Vaccination, Vaccines, DNA, Viremia, Zika Virus, Zika Virus Infection, Biological Sciences, Medical and Health Sciences, Medical biotechnology, Biomedical engineering
Abstract

Zika virus (ZIKV) infection of pregnant women is associated with congenital Zika syndrome (CZS) and no vaccine is available, although several are being tested in clinical trials. We tested the efficacy of ZIKV DNA vaccine VRC5283 in a rhesus macaque model of congenital ZIKV infection. Most animal vaccine experiments have a set pathogen exposure several weeks or months after vaccination. In the real world, people encounter pathogens years or decades after vaccination, or may be repeatedly exposed if the virus is endemic. To more accurately mimic how this vaccine would be used, we immunized macaques before conception and then exposed them repeatedly to ZIKV during early and mid-gestation. In comparison to unimmunized animals, vaccinated animals had a significant reduction in peak magnitude and duration of maternal viremia, early fetal loss, fetal infection, and placental and fetal brain pathology. Vaccine-induced neutralizing antibody titers on the day of first ZIKV exposure were negatively associated with the magnitude of maternal viremia, and the absence of prolonged viremia was associated with better fetal outcomes. These data support further clinical development of ZIKV vaccine strategies to protect against negative fetal outcomes.

Published
2019

15. Contributors

Author

Abzug, Mark J., primary, Acharya, Priyamvada, additional, Acosta, Anna M., additional, Ahmed, S. Sohail, additional, Amanna, Ian J., additional, Anderson, Annaliesa S., additional, Asturias, Edwin J., additional, Bachmann, Martin F., additional, Bahl, Sunil, additional, Bailey, Justin R., additional, Baker, Carol J., additional, Balfour, Henry H., additional, Baric, Ralph S., additional, Barnett, Elizabeth D., additional, Barrett, Alan D.T., additional, Belser, Jessica A., additional, Berzofsky, Jay A., additional, Bethony, Jeffrey M., additional, Brewer-Jensen, Paul D., additional, Bubak, Andrew N., additional, Burns, Cara C., additional, Caplan, Arthur L., additional, Cavaleri, Marco, additional, Chandran, Aruna, additional, Cherian, Thomas, additional, Clemens, John D., additional, Cochino, Emil, additional, Cohet, Catherine, additional, Cohn, Amanda, additional, Cortese, Margaret M., additional, Crowcroft, Natasha S., additional, Curtis, Nigel, additional, Damron, F. Heath, additional, Danchin, Margie, additional, Debbink, Kari, additional, Desai, Sachin N., additional, Davis, Emily H., additional, Decker, Michael D., additional, Denison, Mark R., additional, DeStefano, Frank, additional, Douglas, R. Gordon, additional, Dreher-Lesnick, Sheila M., additional, Eberhardt, Christiane S., additional, Edmunds, W. John, additional, Edwards, Caitlin E., additional, Edwards, Kathryn M., additional, Eggers, Rudolf, additional, Ellis, Ronald, additional, Erdman, Dean D., additional, Ertl, Hildegund C.J., additional, Estivariz, Concepcion F., additional, Fine, Paul E.M., additional, Finn, Theresa M., additional, Fisher, Allison M., additional, Fitzwater, Sean Patrick, additional, Freedman, Mark S., additional, Friede, Martin, additional, Friedlander, Arthur M., additional, Frumento, Nicole, additional, Fry, Alicia M., additional, Garçon, Nathalie, additional, Geris, Jennifer M., additional, Gershon, Anne A., additional, Gervier, Regis, additional, Gessner, Bradford D., additional, Gilbert, Peter B., additional, Gomez, Phillip Louis, additional, Ginsberg, Ann M., additional, Grabenstein, John D., additional, Graham, Rachel L., additional, Graham, Barney S., additional, Granoff, Dan M., additional, Gray, Gregory C., additional, Greenberg, David P., additional, Grohskopf, Lisa A., additional, Gruber, Marion F., additional, Guerena, Fernando B., additional, Havelange, Nicolas, additional, Halstead, Scott B., additional, Hanekom, Willem A., additional, Harrison, Lee H., additional, Hawn, Thomas R., additional, Haynes, Barton F., additional, Healy, C. Mary, additional, Hills, Susan L., additional, Hirabayashi, Kuniko, additional, Holmgren, Jan, additional, Hombach, Joachim M., additional, Hotez, Peter Jay, additional, Howe, Barbara J., additional, Hunegnaw, Ruth, additional, Izopet, Jacques, additional, Jamieson, Denise J., additional, Jansen, Kathrin, additional, Jarrahian, Courtney, additional, Johansen, Kari, additional, Kahn, Geoffrey D., additional, Karron, Ruth A., additional, Katz, Jacqueline M., additional, Kennedy, Richard B., additional, Broojerdi, Alireza Khadem, additional, Khetsuriani, Nino, additional, Khudyakov, Yury, additional, Klugman, Keith P., additional, Kocher, Jacob F., additional, Kollaritsch, Herwig, additional, Kotloff, Karen L., additional, Kozarsky, Phyllis E., additional, Kreimer, Aimée R., additional, Kroger, Andrew T., additional, Kwong, Peter D., additional, Lal, Manjari, additional, Levin, Myron J., additional, Levine, Myron M., additional, Lindesmith, Lisa C., additional, Lindstrand, Ann, additional, Ljungman, Per, additional, Lowy, Douglas R., additional, Lundgren, Anna, additional, Lydon, Patrick, additional, Macklin, Grace R., additional, Maeng, Hoyoung M., additional, Mahalingam, Ravi, additional, Malley, Richard, additional, Mallory, Michael L., additional, Marfin, Anthony A., additional, Markowitz, Lauri E., additional, Marshall, CDR Valerie, additional, McCollum, Andrea, additional, Meyer, Sarah, additional, McNamara, Lucy A., additional, Menning, Lisa, additional, Messacar, Kevin, additional, Miller, Mark A., additional, Milutinovic, Pavle, additional, Modlin, John F., additional, Monath, Thomas P., additional, Morabito, Kaitlyn M., additional, Moss, William J., additional, Mulholland, Kim, additional, Mura, Manuela, additional, Musher, Daniel M., additional, Nagel, Maria A., additional, Nair, G. Balakrish, additional, Nelson, Noele P., additional, Netea, Mihai G., additional, Neuzil, Kathleen Maletic, additional, Niemeyer, Christy S., additional, Nohynek, Hanna, additional, Norheim, Gunnstein, additional, Nussbaum, Lauren, additional, O’Brien, Katherine L., additional, O’Leary, Sean, additional, Ockenhouse, Christian, additional, Offit, Paul A., additional, Okwo-Bele, Jean-Marie, additional, Olkhanud, Purevdorj B., additional, Omer, Saad B., additional, Orenstein, Walter A., additional, Oyston, Petra C.F., additional, Parashar, Umesh D., additional, Patel, Manish M., additional, Payne, Daniel C., additional, Pebody, Richard, additional, Pecetta, Simone, additional, Perlman, Stanley, additional, Pierson, Benjamin, additional, Pierson, Theodore C., additional, Pittet, Laure F., additional, Pittman, Phillip R., additional, Plotkin, Stanley A., additional, Plotkin, Susan L., additional, Poland, Gregory A., additional, Pollard, Sir Andrew John, additional, Poovorawan, Yong, additional, Proctor, Richard A., additional, Qadri, Firdausi, additional, Rao, Agam, additional, Rappuoli, Rino, additional, Reef, Susan E., additional, Rogalewicz, Joseph A., additional, Robinson, James Michael, additional, Roesel, Sigrun, additional, Rubin, Steven A., additional, Rupprecht, Charles E., additional, Rutter, Paul, additional, Samant, Vijay B., additional, Sambhara, Suryaprakash, additional, Samies, Nicole L., additional, Santosham, Mathuram, additional, Saunders, Kevin O., additional, Schiller, John T., additional, Schleiss, Mark R., additional, Schuerman, Lode, additional, Schwab, Jennifer, additional, Schwartz, Jason L., additional, Scobie, Heather M., additional, Scott, J. Anthony, additional, Shapiro, Eugene D., additional, Shenoy, Erica S., additional, Shimabukuro, Tom T., additional, Shouval, Daniel, additional, Siegrist, Claire-Anne, additional, Sitrin, Robert D., additional, Skinner, Nicole E., additional, Slifka, Mark K., additional, Sodha, Samir V., additional, Soeters, Heidi M., additional, Solomon, Tom, additional, Speiser, Daniel E., additional, Staples, J. Erin, additional, Steffen, Robert, additional, Stephens, David S., additional, Strebel, Peter M., additional, Subbarao, Kanta, additional, Sullivan, Nancy J., additional, Takashima, Yoshihiro, additional, Tate, Jacqueline E., additional, Tayman, Alice, additional, Telford, Sam R., additional, Thombley, Melisa, additional, Thomsen, Isaac, additional, Tohme, Rania A., additional, Trabold, Malin, additional, El-Turabi, Aadil, additional, Vaughn, David W., additional, Verardi, Raffaello, additional, Vicari, Andrea S., additional, Vidor, Emmanuel J., additional, Villafana, Tonya, additional, Vogt, Matthew R., additional, Walker, Mark J., additional, Walsh, Nick M., additional, Wanlapakorn, Nasamon, additional, Ward, John W., additional, Wassilak, Steven G.F., additional, Watts, Lisa A., additional, Weber, David J., additional, Weiner, David B., additional, Weng, Mark K., additional, Wexler, Deborah L., additional, Wharton, Melinda, additional, Whitley, Richard J., additional, Whitney, Cynthia G., additional, Wiehe, Kevin, additional, Williamson, E. Diane, additional, Wormser, Gary P., additional, Xia, Ningshao, additional, Yildirim, Inci, additional, Zehrung, Darin, additional, and Zweigart, Mark R., additional

Published
2023
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16. Respiratory syncytial virus prevention within reach: the vaccine and monoclonal antibody landscape

Author

Mazur, Natalie I, Terstappen, Jonne, Baral, Ranju, Bardají, Azucena, Beutels, Philippe, Buchholz, Ursula J, Cohen, Cheryl, Crowe, James E, Jr, Cutland, Clare L, Eckert, Linda, Feikin, Daniel, Fitzpatrick, Tiffany, Fong, Youyi, Graham, Barney S, Heikkinen, Terho, Higgins, Deborah, Hirve, Siddhivinayak, Klugman, Keith P, Kragten-Tabatabaie, Leyla, Lemey, Philippe, Libster, Romina, Löwensteyn, Yvette, Mejias, Asuncion, Munoz, Flor M, Munywoki, Patrick K, Mwananyanda, Lawrence, Nair, Harish, Nunes, Marta C, Ramilo, Octavio, Richmond, Peter, Ruckwardt, Tracy J, Sande, Charles, Srikantiah, Padmini, Thacker, Naveen, Waldstein, Kody A, Weinberger, Dan, Wildenbeest, Joanne, Wiseman, Dexter, Zar, Heather J, Zambon, Maria, and Bont, Louis

Published
2023
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17. 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., and Mascola, John R.

Published
2022
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18. Co-immunization with hemagglutinin stem immunogens elicits cross-group neutralizing antibodies and broad protection against influenza A viruses

Author

Moin, Syed M., Boyington, Jeffrey C., Boyoglu-Barnum, Seyhan, Gillespie, Rebecca A., Cerutti, Gabriele, Cheung, Crystal Sao-Fong, Cagigi, Alberto, Gallagher, John R., Brand, Joshua, Prabhakaran, Madhu, Tsybovsky, Yaroslav, Stephens, Tyler, Fisher, Brian E., Creanga, Adrian, Ataca, Sila, Rawi, Reda, Corbett, Kizzmekia S., Crank, Michelle C., Karlsson Hedestam, Gunilla B., Gorman, Jason, McDermott, Adrian B., Harris, Audray K., Zhou, Tongqing, Kwong, Peter D., Shapiro, Lawrence, Mascola, John R., Graham, Barney S., and Kanekiyo, Masaru

Published
2022
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19. Atomic structures of enterovirus D68 in complex with two monoclonal antibodies define distinct mechanisms of viral neutralization

Author

Zheng, Qingbing, Zhu, Rui, Xu, Longfa, He, Maozhou, Yan, Xiaodong, Liu, Dongxiao, Yin, Zhichao, Wu, Yangtao, Li, Yongchao, Yang, Lisheng, Hou, Wangheng, Li, Shuxuan, Li, Zizhen, Chen, Zhenqin, Li, Zhihai, Yu, Hai, Gu, Ying, Zhang, Jun, Baker, Timothy S, Zhou, Z Hong, Graham, Barney S, Cheng, Tong, Li, Shaowei, and Xia, Ningshao

Subjects
Microbiology, Biological Sciences, Infectious Diseases, Biotechnology, 2.2 Factors relating to the physical environment, Aetiology, 2.1 Biological and endogenous factors, Infection, Animals, Antibodies, Monoclonal, Antibodies, Neutralizing, Antigen-Antibody Complex, Capsid, Cell Adhesion Molecules, Cell Line, Tumor, Cryoelectron Microscopy, Enterovirus, Enterovirus D, Human, Humans, Mice, Mice, Inbred BALB C, Nerve Tissue Proteins, Medical Microbiology
Abstract

Enterovirus D68 (EV-D68) undergoes structural transformation between mature, cell-entry intermediate (A-particle) and empty forms throughout its life cycle. Structural information for the various forms and antibody-bound capsids will facilitate the development of effective vaccines and therapeutics against EV-D68 infection, which causes childhood respiratory and paralytic diseases worldwide. Here, we report the structures of three EV-D68 capsid states representing the virus at major phases. We further describe two original monoclonal antibodies (15C5 and 11G1) with distinct structurally defined mechanisms for virus neutralization. 15C5 and 11G1 engage the capsid loci at icosahedral three-fold and five-fold axes, respectively. To block viral attachment, 15C5 binds three forms of capsids, and triggers mature virions to transform into A-particles, mimicking engagement by the functional receptor ICAM-5, whereas 11G1 exclusively recognizes the A-particle. Our data provide a structural and molecular explanation for the transition of picornavirus capsid conformations and demonstrate distinct mechanisms for antibody-mediated neutralization.

Published
2019

20. 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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22. 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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23. A single residue in influenza virus H2 hemagglutinin enhances the breadth of the B cell response elicited by H2 vaccination

Author

Andrews, Sarah F., Raab, Julie E., Gorman, Jason, Gillespie, Rebecca A., Cheung, Crystal S. F., Rawi, Reda, Cominsky, Lauren Y., Boyington, Jeffrey C., Creanga, Adrian, Shen, Chen-Hsiang, Harris, Darcy R., Olia, Adam S., Nazzari, Alexandra F., Zhou, Tongqing, Houser, Katherine V., Chen, Grace L., Mascola, John R., Graham, Barney S., Kanekiyo, Masaru, Ledgerwood, Julie E., Kwong, Peter D., and McDermott, Adrian B.

Published
2022
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26. Structure-based design of stabilized recombinant influenza neuraminidase tetramers

Author

Ellis, Daniel, Lederhofer, Julia, Acton, Oliver J., Tsybovsky, Yaroslav, Kephart, Sally, Yap, Christina, Gillespie, Rebecca A., Creanga, Adrian, Olshefsky, Audrey, Stephens, Tyler, Pettie, Deleah, Murphy, Michael, Sydeman, Claire, Ahlrichs, Maggie, Chan, Sidney, Borst, Andrew J., Park, Young-Jun, Lee, Kelly K., Graham, Barney S., Veesler, David, King, Neil P., and Kanekiyo, Masaru

Published
2022
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28. Prior Dengue Virus Exposure Shapes T Cell Immunity to Zika Virus in Humans

Author

Grifoni, Alba, Pham, John, Sidney, John, O'Rourke, Patrick H, Paul, Sinu, Peters, Bjoern, Martini, Sheridan R, de Silva, Aruna D, Ricciardi, Michael J, Magnani, Diogo M, Silveira, Cassia GT, Maestri, Alvino, Costa, Priscilla R, de-Oliveira-Pinto, Luzia Maria, de Azeredo, Elzinandes Leal, Damasco, Paulo Vieira, Phillips, Elizabeth, Mallal, Simon, de Silva, Aravinda M, Collins, Matthew, Durbin, Anna, Diehl, Sean A, Cerpas, Cristhiam, Balmaseda, Angel, Kuan, Guillermina, Coloma, Josefina, Harris, Eva, Crowe, James E, Stone, Mars, Norris, Phillip J, Busch, Michael, Vivanco-Cid, Hector, Cox, Josephine, Graham, Barney S, Ledgerwood, Julie E, Turtle, Lance, Solomon, Tom, Kallas, Esper G, Watkins, David I, Weiskopf, Daniela, and Sette, Alessandro

Subjects
Vaccine Related, Infectious Diseases, Immunization, Emerging Infectious Diseases, Biodefense, Prevention, Vector-Borne Diseases, Biotechnology, 2.1 Biological and endogenous factors, Aetiology, Infection, Inflammatory and immune system, Good Health and Well Being, Adolescent, Adult, Aged, Child, Child, Preschool, Cohort Studies, Cross Reactions, Dengue Vaccines, Dengue Virus, Epitopes, T-Lymphocyte, Female, Humans, Male, Middle Aged, T-Lymphocytes, Vaccines, Attenuated, Young Adult, Zika Virus, Zika Virus Infection, ZIKV, DENV, T cells, heterologous immunity, cross-reactivity, immunodominance, Biological Sciences, Agricultural and Veterinary Sciences, Medical and Health Sciences, Virology
Abstract

While progress has been made in characterizing humoral immunity to Zika virus (ZIKV) in humans, little is known regarding the corresponding T cell responses to ZIKV. Here, we investigate the kinetics and viral epitopes targeted by T cells responding to ZIKV and address the critical question of whether preexisting dengue virus (DENV) T cell immunity modulates these responses. We find that memory T cell responses elicited by prior infection with DENV or vaccination with tetravalent dengue attenuated vaccines (TDLAV) recognize ZIKV-derived peptides. This cross-reactivity is explained by the sequence similarity of the two viruses, as the ZIKV peptides recognized by DENV-elicited memory T cells are identical or highly conserved in DENV and ZIKV. DENV exposure prior to ZIKV infection also influences the timing and magnitude of the T cell response. ZIKV-reactive T cells in the acute phase of infection are detected earlier and in greater magnitude in DENV-immune patients. Conversely, the frequency of ZIKV-reactive T cells continues to rise in the convalescent phase in DENV-naive donors but declines in DENV-preexposed donors, compatible with more efficient control of ZIKV replication and/or clearance of ZIKV antigen. The quality of responses is also influenced by previous DENV exposure, and ZIKV-specific CD8 T cells from DENV-preexposed donors selectively upregulated granzyme B and PD1, unlike DENV-naive donors. Finally, we discovered that ZIKV structural proteins (E, prM, and C) are major targets of both the CD4 and CD8 T cell responses, whereas DENV T cell epitopes are found primarily in nonstructural proteins.IMPORTANCE The issue of potential ZIKV and DENV cross-reactivity and how preexisting DENV T cell immunity modulates Zika T cell responses is of great relevance, as the two viruses often cocirculate and Zika virus has been spreading in geographical regions where DENV is endemic or hyperendemic. Our data show that memory T cell responses elicited by prior infection with DENV recognize ZIKV-derived peptides and that DENV exposure prior to ZIKV infection influences the timing, magnitude, and quality of the T cell response. Additionally, we show that ZIKV-specific responses target different proteins than DENV-specific responses, pointing toward important implications for vaccine design against this global threat.

Published
2017

29. Stabilized coronavirus spike stem elicits a broadly protective antibody

Author

Hsieh, Ching-Lin, Werner, Anne P., Leist, Sarah R., Stevens, Laura J., Falconer, Ester, Goldsmith, Jory A., Chou, Chia-Wei, Abiona, Olubukola M., West, Ande, Westendorf, Kathryn, Muthuraman, Krithika, Fritch, Ethan J., Dinnon, Kenneth H., III, Schäfer, Alexandra, Denison, Mark R., Chappell, James D., Baric, Ralph S., Graham, Barney S., Corbett, Kizzmekia S., and McLellan, Jason S.

Published
2021
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30. 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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32. 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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34. Antibody resistance of SARS-CoV-2 variants B.1.351 and B.1.1.7

Author

Wang, Pengfei, Nair, Manoj S., Liu, Lihong, Iketani, Sho, Luo, Yang, Guo, Yicheng, Wang, Maple, Yu, Jian, Zhang, Baoshan, Kwong, Peter D., Graham, Barney S., Mascola, John R., Chang, Jennifer Y., Yin, Michael T., Sobieszczyk, Magdalena, Kyratsous, Christos A., Shapiro, Lawrence, Sheng, Zizhang, Huang, Yaoxing, and Ho, David D.

Published
2021
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35. Quadrivalent influenza nanoparticle vaccines induce broad protection

Author

Boyoglu-Barnum, Seyhan, Ellis, Daniel, Gillespie, Rebecca A., Hutchinson, Geoffrey B., Park, Young-Jun, Moin, Syed M., Acton, Oliver J., Ravichandran, Rashmi, Murphy, Mike, Pettie, Deleah, Matheson, Nick, Carter, Lauren, Creanga, Adrian, Watson, Michael J., Kephart, Sally, Ataca, Sila, Vaile, John R., Ueda, George, Crank, Michelle C., Stewart, Lance, Lee, Kelly K., Guttman, Miklos, Baker, David, Mascola, John R., Veesler, David, Graham, Barney S., King, Neil P., and Kanekiyo, Masaru

Published
2021
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37. Severe Acute Respiratory Syndrome Coronavirus 2 Prevalence, Seroprevalence, and Exposure among Evacuees from Wuhan, China, 2020

Author

Hallowell, Benjamin D., Carlson, Christina M., Jacobs, Jesica R., Pomeroy, Mary, Steinberg, Jonathan, Tenforde, Mark W., McDonald, Emily, Foster, Loretta, Feldstein, Leora R., Rolfes, Melissa A., Haynes, Amber, Abedi, Glen R., Odongo, George S., Saruwatari, Kim, Rider, Errin C., Douville, Gina, Bhakta, Neenaben, Maniatis, Panagiotis, Lindstrom, Stephen, Thornburg, Natalie J., Lu, Xiaoyan, Whitaker, Brett L., Kamili, Shifaq, Sakthivel, Senthilkumar K., Wang, Lijuan, Malapati, Lakshmi, Murray, Janna R., Lynch, Brian, Cetron, Martin, Brown, Clive, Roohi, Shahrokh, Rotz, Lisa, Borntrager, Denise, Ishii, Kenta, Moser, Kathleen, Rasheed, Mohammad, Freeman, Brandi, Lester, Sandra, Corbett, Kizzmekia S., Abiona, Olubukola M., Hutchinson, Geoffrey B., Graham, Barney S., Pesik, Nicki, Mahon, Barbara, Braden, Christopher, Behravesh, Casey Barton, Stewart, Rebekah, Knight, Nancy, Hall, Aron J., and Killerby, Marie E.

Subjects
Quarantine -- Health aspects, Severe acute respiratory syndrome -- Health aspects, Coronaviruses -- Health aspects, COVID-19 -- Health aspects, Health
Abstract

On December 31, 2019, a cluster of severe pneumonia cases in Wuhan, Hubei Province, China, was reported (1). On January 7, 2020, a novel coronavirus, severe acute respiratory syndrome coronavirus [...]

Published
2020
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38. Antibody Fc effector functions and IgG3 associate with decreased HIV-1 risk

Author

Neidich, Scott D., Fong, Youyi, Li, Shuying S., Geraghty, Daniel E., Williamson, Brian D., Young, William Chad, Goodman, Derrick, Seaton, Kelly E., Shen, Xiaoying, Sawant, Sheetal, Zhang, Lu, deCamp, Allan C., Blette, Bryan S., Shao, Mengshu, Yates, Nicole L., Feely, Frederick, Pyo, Chul-Woo, Ferrari, Guido, Frank, Ian, Karuna, Shelly T., Swann, Edith M., Mascola, John R., Graham, Barney S., Hammer, Scott M., Sobieszczyk, Magdalena E., Corey, Lawrence, Janes, Holly E., McElrath, M. Juliana, Gottardo, Raphael, Gilbert, Peter B., and Tomaras, Georgia D.

Subjects
Antigens -- Health aspects, AIDS vaccines -- Health aspects, Single nucleotide polymorphisms -- Health aspects, Immunoglobulin A -- Health aspects, HIV -- Risk factors -- Health aspects, Immunoglobulin G -- Health aspects, Adenoviruses -- Health aspects, Vaccines, Clinical trials, Genetic polymorphisms, DNA, Antibodies, Transgender people, Health care industry, Duke University
Abstract

HVTN 505 is a preventative vaccine efficacy trial testing DNA followed by recombinant adenovirus serotype 5 (rAd5) in circumcised, Ad5-seronegative men and transgendered persons who have sex with men in the United States. Identified immune correlates of lower HIV-1 risk and a virus sieve analysis revealed that, despite lacking overall efficacy, vaccine-elicited responses exerted pressure on infecting HIV-1 viruses. To interrogate the mechanism of the antibody correlate of HIV-1 risk, we examined antigen-specific antibody recruitment of Fc[gamma] receptors (Fc[gamma]Rs), antibody-dependent cellular phagocytosis (ADCP), and the role of anti-envelope (anti-Env) IgG3. In a prespecified immune correlates analysis, antibody-dependent monocyte phagocytosis and antibody binding to Fc[gamma]RIIa correlated with decreased HIV-1 risk. Follow-up analyses revealed that anti-Env IgG3 breadth correlated with reduced HIV-1 risk, anti-Env IgA negatively modified infection risk by Fc effector functions, and that vaccine recipients with a specific Fc[gamma]RIIa single-nucleotide polymorphism locus had a stronger correlation with decreased HIV-1 risk when ADCP, Env-Fc[gamma]RIIa, and IgG3 binding were high. Additionally, Fc[gamma]RIIa engagement correlated with decreased viral load setpoint in vaccine recipients who acquired HIV-1. These data support a role for vaccine-elicited anti-HIV-1 Env IgG3, antibody engagement of FcRs, and phagocytosis as potential mechanisms for HIV-1 prevention., Introduction An efficacious vaccine that provides durable immunity remains a key priority in the fight against HIV-1. One strategy to identify an efficacious vaccine regimen is the identification of immune [...]

Published
2019
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39. Animal models for COVID-19

Author

Muñoz-Fontela, César, Dowling, William E., Funnell, Simon G. P., Gsell, Pierre-S., Riveros-Balta, A. Ximena, Albrecht, Randy A., Andersen, Hanne, Baric, Ralph S., Carroll, Miles W., Cavaleri, Marco, Qin, Chuan, Crozier, Ian, Dallmeier, Kai, de Waal, Leon, de Wit, Emmie, Delang, Leen, Dohm, Erik, Duprex, W. Paul, Falzarano, Darryl, Finch, Courtney L., Frieman, Matthew B., Graham, Barney S., Gralinski, Lisa E., Guilfoyle, Kate, Haagmans, Bart L., Hamilton, Geraldine A., Hartman, Amy L., Herfst, Sander, Kaptein, Suzanne J. F., Klimstra, William B., Knezevic, Ivana, Krause, Philip R., Kuhn, Jens H., Le Grand, Roger, Lewis, Mark G., Liu, Wen-Chun, Maisonnasse, Pauline, McElroy, Anita K., Munster, Vincent, Oreshkova, Nadia, Rasmussen, Angela L., Rocha-Pereira, Joana, Rockx, Barry, Rodríguez, Estefanía, Rogers, Thomas F., Salguero, Francisco J., Schotsaert, Michael, Stittelaar, Koert J., Thibaut, Hendrik Jan, Tseng, Chien-Te, Vergara-Alert, Júlia, Beer, Martin, Brasel, Trevor, Chan, Jasper F. W., García-Sastre, Adolfo, Neyts, Johan, Perlman, Stanley, Reed, Douglas S., Richt, Juergen A., Roy, Chad J., Segalés, Joaquim, Vasan, Seshadri S., Henao-Restrepo, Ana María, and Barouch, Dan H.

Published
2020
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40. SARS-CoV-2 mRNA vaccine design enabled by prototype pathogen preparedness

Author

Corbett, Kizzmekia S., Edwards, Darin K., Leist, Sarah R., Abiona, Olubukola M., Boyoglu-Barnum, Seyhan, Gillespie, Rebecca A., Himansu, Sunny, Schäfer, Alexandra, Ziwawo, Cynthia T., DiPiazza, Anthony T., Dinnon, Kenneth H., Elbashir, Sayda M., Shaw, Christine A., Woods, Angela, Fritch, Ethan J., Martinez, David R., Bock, Kevin W., Minai, Mahnaz, Nagata, Bianca M., Hutchinson, Geoffrey B., Wu, Kai, Henry, Carole, Bahl, Kapil, Garcia-Dominguez, Dario, Ma, LingZhi, Renzi, Isabella, Kong, Wing-Pui, Schmidt, Stephen D., Wang, Lingshu, Zhang, Yi, Phung, Emily, Chang, Lauren A., Loomis, Rebecca J., Altaras, Nedim Emil, Narayanan, Elisabeth, Metkar, Mihir, Presnyak, Vlad, Liu, Cuiping, Louder, Mark K., Shi, Wei, Leung, Kwanyee, Yang, Eun Sung, West, Ande, Gully, Kendra L., Stevens, Laura J., Wang, Nianshuang, Wrapp, Daniel, Doria-Rose, Nicole A., Stewart-Jones, Guillaume, Bennett, Hamilton, Alvarado, Gabriela S., Nason, Martha C., Ruckwardt, Tracy J., McLellan, Jason S., Denison, Mark R., Chappell, James D., Moore, Ian N., Morabito, Kaitlyn M., Mascola, John R., Baric, Ralph S., Carfi, Andrea, and Graham, Barney S.

Published
2020
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42. Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial

Author

Mendoza, Floreliz, Novik, Laura, Zephir, Kathy, Whalen, William, Larkin, Brenda, Saunders, Jamie, Cunningham, Jennifer, Levinson, Carol, Wang, Xiaolin, Plummer, Sarah, Victorino, Milalynn, Ola, Abidemi, Boyd, Catina, Jayasinghe, Nilusha, Apte, Preeti, Cartagena, Cora Trelles, Hicks, Renunda, Williams, Pernell, Vasilenko, Olga, Yamshchikov, Galina, Florez, Maria Burgos, Pittman, Iris, Gama, Lucio, Casazza, Joseph, DeCederfelt, Hope, Cheng, KC, Stein, Judy, Gaudinski, Martin R, Houser, Katherine V, Doria-Rose, Nicole A, Chen, Grace L, Rothwell, Ro Shauna S, Berkowitz, Nina, Costner, Pamela, Holman, LaSonji A, Gordon, Ingelise J, Hendel, Cynthia S, Kaltovich, Florence, Conan-Cibotti, Michelle, Gomez Lorenzo, Margarita, Carter, Cristina, Sitar, Sandra, Carlton, Kevin, Gall, Jason, Laurencot, Carolyn, Lin, Bob C, Bailer, Robert T, McDermott, Adrian B, Ko, Sung-Youl, Pegu, Amarendra, Kwon, Young D, Kwong, Peter D, Namboodiri, Aryan M, Pandey, Janardan P, Schwartz, Richard, Arnold, Frank, Hu, Zonghui, Zhang, Lily, Huang, Yunda, Koup, Richard A, Capparelli, Edmund V, Graham, Barney S, Mascola, John R, and Ledgerwood, Julie E

Published
2019
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43. Safety and efficacy of VRC01 broadly neutralising antibodies in adults with acutely treated HIV (RV397): a phase 2, randomised, double-blind, placebo-controlled trial

Author

Ake, Julie A., Akapirat, Siriwat, Bose, Meera, Cale, Evan, Chan, Phillip, Chanthaburanun, Sararut, Churikanont, Nampueng, Dawson, Peter, Dumrongpisutikul, Netsiri, Getchalarat, Saowanit, Jongrakthaitae, Surat, Jongsakul, Krisada, Lerdlum, Sukalaya, Manasnayakorn, Sopark, McCullough, Corinne, Milazzo, Mark, Nuntapinit, Bessara, On, Kier, Ouellette, Madelaine, Phanuphak, Praphan, Sanders-Buell, Eric, Sangnoi, Nongluck, Shangguan, Shida, Sirivichayakul, Sunee, Tragonlugsana, Nipattra, Trichavaroj, Rapee, Ubolyam, Sasiwimol, Vasan, Sandhya, Wattanaboonyongcharoen, Phandee, Yamchuenpong, Thipvadee, Crowell, Trevor A, Colby, Donn J, Pinyakorn, Suteeraporn, Sacdalan, Carlo, Pagliuzza, Amélie, Intasan, Jintana, Benjapornpong, Khunthalee, Tangnaree, Kamonkan, Chomchey, Nitiya, Kroon, Eugène, de Souza, Mark S, Tovanabutra, Sodsai, Rolland, Morgane, Eller, Michael A, Paquin-Proulx, Dominic, Bolton, Diane L, Tokarev, Andrey, Thomas, Rasmi, Takata, Hiroshi, Trautmann, Lydie, Krebs, Shelly J, Modjarrad, Kayvon, McDermott, Adrian B, Bailer, Robert T, Doria-Rose, Nicole, Patel, Bijal, Gorelick, Robert J, Fullmer, Brandie A, Schuetz, Alexandra, Grandin, Pornsuk V, O'Connell, Robert J, Ledgerwood, Julie E, Graham, Barney S, Tressler, Randall, Mascola, John R, Chomont, Nicolas, Michael, Nelson L, Robb, Merlin L, Phanuphak, Nittaya, and Ananworanich, Jintanat

Published
2019
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45. Vaccination with prefusion-stabilized respiratory syncytial virus fusion protein elicits antibodies targeting a membrane-proximal epitope

Author

McCool, Ryan S., primary, Musayev, Maryam, additional, Bush, Sabrina M., additional, Derrien-Colemyn, Alexandrine, additional, Acreman, Cory M., additional, Wrapp, Daniel, additional, Ruckwardt, Tracy J., additional, Graham, Barney S., additional, Mascola, John R., additional, and McLellan, Jason S., additional

Published
2023
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47. Modification of the Association Between T-Cell Immune Responses and Human Immunodeficiency Virus Type 1 Infection Risk by Vaccine-Induced Antibody Responses in the HVTN 505 Trial

Author

Fong, Youyi, Shen, Xiaoying, Ashley, Vicki C., Deal, Aaron, Seaton, Kelly E., Yu, Chenchen, Grant, Shannon P., Ferrari, Guido, deCamp, Allan C., Bailer, Robert T., Koup, Richard A., Montefiori, David, Haynes, Barton F., Sarzotti-Kelsoe, Marcella, Graham, Barney S., Carpp, Lindsay N., Hammer, Scott M., Sobieszczyk, Magda, Karuna, Shelly, Swann, Edith, DeJesus, Edwin, Mulligan, Mark, Frank, Ian, Buchbinder, Susan, Novak, Richard M., McElrath, M. Juliana, Kalams, Spyros, Keefer, Michael, Frahm, Nicole A., Janes, Holly E., Gilbert, Peter B., and Tomaras, Georgia D.

Published
2018

49. List of Contributors

Author

Abraham, Soman N., primary, Artis, David, additional, Attia, Zayed, additional, Azegami, Tatsuhiko, additional, Babiuk, Lorne A., additional, Barry, Eileen M., additional, Beagley, Kenneth W., additional, Booth, Jayaum S., additional, Bost, Kenneth L., additional, Boyaka, Prosper N., additional, Bryan, Emily R., additional, Carlin, Nils, additional, Carr, Daniel J.J., additional, Choi, Hae Woong, additional, Chu, Hiutung, additional, Clemens, John D., additional, Coban, Cevayir, additional, Cormet-Boyaka, Estelle, additional, Crank, Michelle C., additional, Darville, Toni, additional, Derrick, Steven C., additional, Ding, Siyuan, additional, Drygiannakis, Ioannis, additional, Emmer, Kristel L., additional, Ernst, Peter B., additional, Ertl, Hildegund C.J., additional, Fujihashi, Kohtaro, additional, Fujimoto, Kosuke, additional, Gerdts, Volker, additional, Graham, Barney S., additional, Grau, Katrina R., additional, Greenberg, Harry B., additional, Hasegawa, Hideki, additional, Hashizume-Takizawa, Tomomi, additional, Hedges, Jodi F., additional, Hickey, Danica K., additional, Hirahara, Kiyoshi, additional, Holmgren, Jan, additional, Huys, Adam, additional, Ishii, Hiroshi, additional, Iwasaki, Akiko, additional, Jiang, Yanlong, additional, Jobin, Christian, additional, Johnson-Weaver, Brandi T., additional, Jutila, Mark A., additional, Karst, Stephanie M., additional, Kato, Hirotomo, additional, Kawamoto, Eiji, additional, Kawauchi, Hideyuki, additional, Kayama, Hisako, additional, Kelsall, Brian L., additional, Kemter, Andrea M., additional, Kim, Eunsoo, additional, Kiyono, Hiroshi, additional, Kobayashi, Ryoki, additional, Kollipara, Avinash, additional, Kong, Qingke, additional, Kunisawa, Jun, additional, Kurita-Ochiai, Tomoko, additional, Kweon, Mi-Na, additional, Lee, De’Ashia, additional, Lee, Michelle Sue Jann, additional, Longman, Randy S., additional, Lycke, Nils, additional, Mangold, Jesse, additional, Martinez, David R., additional, Matano, Tetsuro, additional, McDaniel, Larry S., additional, Mestecky, Jiri, additional, Metz, Maeva, additional, Meyer, Thomas F., additional, Montgomery, Micaela L., additional, Morabito, Kaitlyn M., additional, Morey, Pau, additional, Mulvey, Peter, additional, Nagler, Cathryn R., additional, Nakahashi-Ouchida, Rika, additional, Nakayama, Toshinori, additional, Ogra, Pearay L., additional, Oh, Ji Eun, additional, Park, Eun Jeong, additional, Pascual, David W., additional, Pasetti, Marcela F., additional, Permar, Sallie R., additional, Piller, Kenneth J., additional, Pope, Jillian L., additional, Pulendran, Bali, additional, Qadri, Firdausi, additional, Randall, Troy D., additional, Rhee, Joon Haeng, additional, Roland, Kenneth L., additional, Royer, Derek J., additional, Ruckwardt, Tracy J., additional, Russell, Michael W., additional, Sato, Shintaro, additional, Sen, Adrish, additional, Shimaoka, Motomu, additional, Silva-Sanchez, Aaron, additional, Staats, Herman F., additional, Suzuki, Hidehiko, additional, Svennerholm, Ann-Mari, additional, Swiatlo, Edwin, additional, Sztein, Marcelo B., additional, Takeda, Kiyoshi, additional, Toapanta, Franklin R., additional, Tomkovich, Sarah, additional, Trim, Logan, additional, Tsujimura, Yusuke, additional, Uematsu, Satoshi, additional, Venkatesan, Malabi M., additional, Wilson, Heather L., additional, Yamamoto, Hiroyuki, additional, Yamamoto, Masafumi, additional, Yasutomi, Yasuhiro, additional, and Yuki, Yoshikazu, additional

Published
2020
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