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2. Immunogenicity and safety of a bivalent (omicron BA.5 plus ancestral) SARS-CoV-2 recombinant spike protein vaccine as a heterologous booster dose: interim analysis of a phase 3, non-inferiority, randomised, clinical trial

Author

Anderson, Anna, Ang, Mary, Barnes, Timothy, Bassin, Michelle, Bessey, Kate, Bowler, Simon, Bull, Sheetal, Burr, Lucy, Burton, Robert, Byrne, Michelle, Carroll, Robert, Chee, Nicholas, Choy, Aaron, Clark, Malcolm, Dalebout, Marije, De Wet, Peter, Deshmukh, Kshama, Diez Alvarez, Sergio, Douglas, Dominic, Engelander, Jacqueline, Evangelista, Carla, Game, Stuart, Glass, Noor, Gunner, Elizabeth, Han, Jennifer, Harrison, Michael, Hing Kiang, Jason Doong, Hlaing, Thazin, Joshi, Divyansh, Joyce, Sheree, Kaluhin, Karen, Kavic, Milanka, Kononov, Juliana, Lee, Gary, Lee, Wei-I, Leelasena, Indika, Leong, Esmond, Lim, Ivan, Lister, Graham, Loh, Denissa, Magdy, Mary, Maggs, Callum, Mammoottil, Amith, McCarthy, Shannon, McKay, Nicole, Melek, Mariah, Michael Barnett, Adrian, Mohan, Rahul, Moore, Andrew, Moore, Amanda, Murdoch, Louise, Napier-Flood, Fiona, Narsai, Ushma, Neville, Alexander, Nguyen, Paul, Odarchenko, Ekaterina, Pardey, Toni, Quan, Dick, Ranagsinghe, Ushank, Rasalam, Roy, Rayar, Shiva, Ruthnam, Gonasagaran Jay, Seet, Pi, Smith, Deon, Srilakshmanan, Krishna, Taggart, Angela, Tiong, Florence, Toh, Boon, Ujvary, Eniko, Wallace, Stephanie, Wolf, Rebecca, Wong, Ian, Yoo, Hye, Young, Rhys, Bennett, Chijioke, Woo, Wayne, Bloch, Mark, Cheung, King, Griffin, Paul, Deshmukh, Sachin, Arya, Mark, Cumming, Oscar, Neville, A Munro, McCallum Pardey, Toni G, Plested, Joyce S, Cloney-Clark, Shane, Zhu, Mingzhu, Kalkeri, Raj, Patel, Nita, Marcheschi, Alex, Swan, Jennifer, Smith, Gale, Cho, Iksung, Glenn, Gregory M, Walker, Robert, and Mallory, Raburn M

Published
2024
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4. A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults

Author

Kulkarni, Prasad S., Gunale, Bhagwat, Kohli, Sunil, Lalwani, Sanjay, Tripathy, Srikanth, Kar, Sonali, Raut, Sidram, Kulkarni, Praveen, Apte, Aditi, Bavdekar, Ashish, Bhalla, Hira Lal, Plested, Joyce S., Cloney-Clark, Shane, Zhu, MingZhu, Kalkeri, Raj, Pryor, Melinda, Hamilton, Stephanie, Thakar, Madhuri, Sannidhi, Ranga S., Baranwal, Punjita, Bhamare, Chetanraj, Dharmadhikari, Abhijeet, Gupta, Manish, Poonawalla, Cyrus S., Shaligram, Umesh, and Kapse, Dhananjay

Published
2023
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5. Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study

Author

Kanitkar, Shubhangi A., Kakrani, Arjun L., Tripathy, Srikanth P., Tilak, Abhijit V., Dhamne, Akshay A., Mirza, Shahzad Beg, Athavale, Prachi V., Bhowmik, Mandakini, Ratnakar, Parag J., Gupta, Subodh, Deotale, Vijayshri, Jain, Jyoti, Kalantri, Ashwini, Jain, Vineet, Goyal, Nidhi, Arya, Alok, Rongsen-Chandola, Temsunaro, Dasgupta, Shreyasi, Periera, Pratibha, A, Vanmathi, Kawade, Anand, Gondhali, Arunkumar, Kudyar, Palvi, Singh, Abhishek, Yadav, Ravi, Alexander, Alina, Gunasekaran, Venugopalan, Dineshbabu, Sekar, Samantaray, P.C., Ravish, H.S., Kamra, Deepshikha, Gaidhane, Shilpa, Zahiruddin, Quazi Syed, Moni, Merlin, Kumar, Anil, Dravid, Ameet, Mohan, Anant, Suri, Tejas, Patel, Tejas K., Kishore, Surekha, Choche, Rahul, Ghatage, Deepak, Salvi, Sugam, Kulkarni, Prasad S., Kadam, Abhijit, Godbole, Sheela, Bhatt, Varsha, Raut, Abhishek, Kohli, Sunil, Tripathi, Santanu, Kulkarni, Praveen, Ludam, Rakhi, Prabhu, Madhav, Bavdekar, Ashish, Gogtay, Nithya J., Meshram, Sushant, Kadhiravan, Tamilarasu, Kar, Sonali, Narayana, D.H. Ashwath, Samuel, Clarence, Kulkarni, Govind, Gaidhane, Abhay, Sathyapalan, Dipu, Raut, Sidram, Hadda, Vijay, Bhalla, Hira Lal, Bhamare, Chetanraj, Dharmadhikari, Abhijeet, Plested, Joyce S., Cloney-Clarke, Shane, Zhu, Mingzhu, Pryor, Melinda, Hamilton, Stephanie, Thakar, Madhuri, Shete, Ashwini, Gautam, Manish, Gupta, Nivedita, Panda, Samiran, Shaligram, Umesh, Poonawalla, Cyrus S., Bhargava, Balram, Gunale, Bhagwat, and Kapse, Dhananjay

Published
2023
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6. Safety and immunogenicity following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): a secondary analysis of a randomised, placebo-controlled, phase 2 trial

Author

Adams, Mark, Arya, Mark, Athan, Eugene, Berger, Ira, Bradley, Paul, Briskin, Toby, Glover II, Richard, Griffin, Paul, Kim, Joshua, Kitchener, Scott, Klein, Terry, Leah, Amber, Leelasena, Indika, Lemech, Charlotte, Lickliter, Jason, Manning, Mary Beth, Napier-Flood, Fiona, Nugent, Paul, Thackwray, Susan, Turner, Mark, Mallory, Raburn M, Formica, Neil, Pfeiffer, Susan, Wilkinson, Bethanie, Marcheschi, Alex, Albert, Gary, McFall, Heather, Robinson, Michelle, Plested, Joyce S, Zhu, Mingzhu, Cloney-Clark, Shane, Zhou, Bin, Chau, Gordon, Robertson, Andreana, Maciejewski, Sonia, Hammond, Holly L, Baracco, Lauren, Logue, James, Frieman, Matthew B, Smith, Gale, Patel, Nita, and Glenn, Gregory M

Published
2022
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7. Immunogenicity and safety of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine in people living with and without HIV-1 infection: a randomised, controlled, phase 2A/2B trial

Author

Madhi, Shabir A, Moodley, Dhayendre, Hanley, Sherika, Archary, Moherndran, Hoosain, Zaheer, Lalloo, Umesh, Louw, Cheryl, Fairlie, Lee, Fouche, Leon Frederik, Masilela, Mduduzi S L, Singh, Nishanta, Grobbelaar, Coert, Ahmed, Khatija, Benadé, Gabriella, Bhikha, Sutika, Bhorat, As'ad Ebrahim, Bhorat, Qasim, Joseph, Natasha, Dheda, Keertan, Esmail, Aliasgar, Foulkes, Sharne, Goga, Ameena, Oommen Jose, Aylin, Kruger, Gertruida, Kalonji, Dishiki J, Lalloo, Natasha, Lombaard, Johan J, Lombard Koen, Anthonet, Kany Luabeya, Angelique, Mngqibisa, Rosie, Petrick, Friedrich G, Pitsi, Annah, Tameris, Michele, Thombrayil, Asha, Vollgraaff, Pieter-Louis, Cloney-Clark, Shane, Zhu, Mingzhu, Bennett, Chijioke, Albert, Gary, Faust, Emmanuel, Plested, Joyce S, Fries, Lou, Robertson, Andreana, Neal, Susan, Cho, Iksung, Glenn, Greg M, and Shinde, Vivek

Published
2022
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8. A Modified Novel Validated High-Throughput Hemagglutinin Inhibition Assay Using Recombinant Virus-like Particles and Human Red Blood Cells for the Objective Evaluation of Recombinant Hemagglutinin Nanoparticle Seasonal Influenza Vaccine.

Author

Vincent, Timothy S., Zhu, Mingzhu, Parekh, Anand, Patel, Urvashi, Cloney-Clark, Shane, Klindworth, Andrew, Silva, David, Gorinson, Andrew, Miranda, Karlee, Wang, Mi, Longacre, Zachary, Zhou, Bin, Cho, Iksung, Cai, Rongman, Kalkeri, Raj, Fries, Louis, Shinde, Vivek, and Plested, Joyce S.

Subjects
VACCINE immunogenicity, SEASONAL influenza, ERYTHROCYTES, VIRUS-like particles, VACCINE effectiveness
Abstract

Currently available seasonal influenza vaccines confer variable protection due to antigenic changes resulting from the accumulation of diverse mutations. The analysis of new seasonal influenza vaccines is challenging in part due to the limitations of the traditional hemagglutination inhibition (HAI) assay with A/H3N2 strains. An improved and objective novel HAI assay was developed with recombinant virus-like particles (VLPs) and an egg-derived virus as agglutinins, the oseltamivir treatment of VLPs, human red blood cells, and using an automated image reader-based analysis of hemagglutination. HAI validation was demonstrated using four VLPs and egg-derived strains, with 46–56 serum samples tested 12 times in duplicate per strain. The validated HAI assay was precise as indicated by the percent geometric coefficient of variation for intra-, inter-, and total assay precision, as well as accurate as evidenced by percent bias measurements. The assay exhibited linearity, specificity for homologous type/subtype strains, and sensitivity with a starting dilution of 1:10. Assay robustness and sample stability were demonstrated as a percentage difference compared to reference condition. Validated HAI results were equivalent for the single and duplicate sample testing and correlated well with a qualified live wild-type influenza microneutralization assay. These findings demonstrate the suitability of this high-throughput novel modified validated HAI assay for evaluating vaccine immunogenicity and efficacy. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial

Author

Soiza, Roy L., Brittain-Long, Robin, Scicluna, Chiara, Edwards, Carole, Mackay, Lynn, D'Allesandro, Mariella, Nicol, Amy, Norris, Karen, Mann, Sandra, Lawrence, Heather, Valentine, Ruth, Viljoen, Marianne Elizabeth, Pretswell, Carol H., Nicholls, Helen, Munsoor, Imrozia, Meyrick, Agnieszka, Kyriakidou, Christina, Iyengar, Shalini, Jamal, Arham, Richards, Nick, Price, Helen, Rowbotham, Bridie, Bird, Danielle, Smith, Karen, Littler, Olga, Fielding, Kirsty, Townsend-Rose, Anna, Miller, Karen, Davis, Jessica, Elliot-Garwood, Alison, Trottier, Lauren, Edwards, Paul, McFarland, Margaret, Osanlou, Orod, Longshaw, Laura, Stockport, Jane, Grundy, Lynne, Broad, Katharine Lucy, Regan, Karen, Storton, Kim, Ryan-Wakeling, Declan, Wilson, Brad, Munisamy, Malathy, Wright, John, Shenoy, Anil, English, Beverley, Brear, Lucy, Cicconi, Paola, Boffito, Marta, Milinkovic, Ana, Byrne, Ruth, Movahedi, Roya, Housman, Rosalie, Kara, Naveed, Brown, Ellen, Cipriani, Andrea, Attenburrow, Mary-Jane, Smith, Katharine A., Packham, Jonathan, Sparrow, Geoff, Smith, Richard, Rosier, Josephine M., Saja, Khalid, Nago, Nyasha, Camilleri, Brian, Immanuel, Anita, Hamblin, Mike, Osagie, Rawlings, Mohan, Mahalakshmi, Floyd, Hilary, Goddard, Suzanne, Mutgi, Sanjay, Evans, John, McKeon, Sean, Vilimiene, Neringa, Chicano, Rosavic, Hayre, Rachel, Pandaan, Alice, Henshall, Catherine, Serrano, Sonia, Mazzella, Andrea, Rajeswaran, Thurkka, Mathew, Moncy, Bisnauthsing, Karen, Bremner, Laura, Fok, Henry, Morselli, Franca, Cinardo, Paola, Merrick, Blair, Sowole, Lucy, Broadhead, Samantha, Palmer, Natalie, Cordle, Jessica, Goldsmith, Jaimie Wilson, Cooney, Enya, Jackson, Beth, Jayatilleke, Thilina, Cheng, Zelda, Helliwell, Toby, Chudyk, Adrian, Giemza, Rafaela, Villajin, John Lord, Yogo, Noah, Makanju, Esther, Dulawan, Pearl, Nagra, Deepak, Buazon, April, Russell, Alice, Bird, Georgie, Heer, Amardeep, Sarmiento, Rex, Sanghera, Balraj, Mullin, Melanie, Champion, Adam, Bevan, Aisling, Iqbal, Kinzah, Johnson, Alshia, Clark, Rebecca, Shaw, Sarah, Shaw, Steven, Chalk, Amanda, Lovatt, Martin, Lillicrap, Caroline, Parker, Angela, Hansel, Jan, Wong, Zhi, Gan, Galvin, Tuma, Eyad, Minton, Jane, Murira, Jennifer, Saman, Razan, Hall, Alistair, Holliday, Kyra, Khan, Zara, Calderwood, James, Twigg, George, Baker, Helena, Corrigan, Julie, Houseman, Katy, Raguvanshi, Subhra, Heining, Dominic, Weddell, Jake, Glaves, Liz, Thompson, Kim, Davies, Francis, Lambley Burke, Ruth, Thomson, Emma C., Saralaya, Dinesh, Berry, Lisa, Hopewell, Nancy, Gerdes, Leigh, Pacurar, Mihaela, Faust, Saul N., Turner, Jeremy, Jeanes, Christopher, Cooper, Adele, Keshet-Price, Jocelyn, Coke, Lou, Cambell-Kelly, Melissa, Dhatariya, Ketan, Williams, Claire, Marks, Georgina, Sudbury, James, Rodolico, Lisa, Bradley, Judy, Carr, Sharon, Martin, Roisin, Madden, Angelina, Biagioni, Paul, McKenna, Sonia, Clinton, Alison, O'Kane, Maurice, Carter, Justin, Dewhurst, Matthew, Wetherill, Bill, Hoggarth, Thandiwe, Collins, Katrina Lennon, Chowdhury, Marie, Nathoo, Adil, Heinen, Anna, MacDonald, Orla, Hurducas, Claudia, Cifuentes, Liliana, Gill, Harjeevan, Gibson, Andy, West, Raha, Ewing, Jane, Blacow, Rachel, Haughney, John, MacDonald, Jonathan, Seenan, John Paul, Webb, Stewart, O'Leary, Colin, Muir, Scott, White, Beth, Ritchie, Neil, McAuley, Daniel F., Stewart, Jonathan, D'Alessandro, Mariella, Lakeman, Nicki, Purandare, Laura, Browne, Duncan, Tucker, David, Luck, Peter, Everden, Angharad, Trembath, Lisa, Visick, Michael, Morley, Nick, Reid, Laura, Chenoweth, Helen, Maclean, Kirsty, Sheridan, Ray P., Burden, Tom, Lunt, Craig Francis, Todd, Shirley, Estcourt, Stephanie, Pearce, Jasmine Marie, Wilkins, Suzanne, Love-Rouse, Cathryn, Torok-Pollok, Eva, Youle, Mike, Madge, Sara, Solomon, Danielle, Nandani, Aarti, North, Janet M., Hemat, Nargis, Newport, Rachel, Kalra, Philip A., Chukwu, Chukwuma, Wickens, Olivia, O'Loughlin, Vikki, Mistry, Hema, Harrison, Louise, Oliver, Robert, Peers, Anne-Marie, Zadik, Jess, Doyle, Katie, Chadwick, David R., Colling, Kerry, Wroe, Caroline, Branch, Marie, Chilvers, Alison, Essex, Sarah, Stone, Mark, San Francisco Ramos, Alberto, Beales, Emily, Bird, Olivia, Danos, Zsofia, Fofie, Hazel, Hultin, Cecilia, Ikram, Sabina, Mabesa, Fran, Mescall, Aoife, Pereira, Josyanne, Pearce, Jennifer, Sutton, Natalina, Snashall, Emma, Baxter, David Neil, Bennett, Sara, Suggitt, Debbie, Hughes, Kerry, Woodyatt, Wiesia, Beacon, Lynsey, Kent, Alissa, Cooper, Chris, Rudic, Milan, Tunstall, Simon, Jackson, Matthew, Hombersley, Claire, Moore, Patrick, Cutts, Rebecca, Higham, Andrew, Bukhari, Marwan, Elnaggar, Mohamed, Glover, Michelle, Richardson, Fiona, Dent, Alexandra, Mirza, Shahzeb, Ark, Rajiv, Han, Jennie, Hope, Suzy V., Mitchelmore, Philip J., Osanlou, Rostam, Freedman, Andrew, Cooper, Alison, Burton, Katherine, Katechia, Kashyap, Barrett, Michael, Salkeld, Jo, Hill, Natalie, Lee, Nathaniel, Perkins, Jon, Fox, Polly, Toback, Seth, Galiza, Eva, Cosgrove, Catherine, Galloway, James, Goodman, Anna L, Swift, Pauline A, Rajaram, Sankarasubramanian, Graves-Jones, Alison, Edelman, Jonathan, Burns, Fiona, Minassian, Angela M, Cho, Iksung, Kumar, Lakshmi, Plested, Joyce S, Rivers, E Joy, Robertson, Andreana, Dubovsky, Filip, Glenn, Greg, and Heath, Paul T

Published
2022
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10. Comparison of the safety and immunogenicity of a novel Matrix-M-adjuvanted nanoparticle influenza vaccine with a quadrivalent seasonal influenza vaccine in older adults: a phase 3 randomised controlled trial

Author

Shinde, Vivek, Cho, Iksung, Plested, Joyce S, Agrawal, Sapeckshita, Fiske, Jamie, Cai, Rongman, Zhou, Haixia, Pham, Xuan, Zhu, Mingzhu, Cloney-Clark, Shane, Wang, Nan, Zhou, Bin, Lewis, Maggie, Price-Abbott, Patty, Patel, Nita, Massare, Michael J, Smith, Gale, Keech, Cheryl, Fries, Louis, and Glenn, Gregory M

Published
2022
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11. Immunogenicity and Safety of Heterologous Omicron BA.1 and Bivalent SARS-CoV-2 Recombinant Spike Protein Booster Vaccines: A Phase 3 Randomized Clinical Trial.

Author

Bennett, Chijioke, Rivers, E Joy, Woo, Wayne, Bloch, Mark, Cheung, King, Griffin, Paul, Mohan, Rahul, Deshmukh, Sachin, Arya, Mark, Cumming, Oscar, Neville, A Munro, Pardey, Toni McCallum, Plested, Joyce S, Cloney-Clark, Shane, Zhu, Mingzhu, Kalkeri, Raj, Patel, Nita, Buchanan, Agi, Marcheschi, Alex, and Swan, Jennifer

Subjects
BOOSTER vaccines, CLINICAL trial registries, SARS-CoV-2 Omicron variant, SARS-CoV-2, COVID-19 vaccines
Abstract

Background Mutations present in emerging SARS-CoV-2 variants permit evasion of neutralization with prototype vaccines. A novel Omicron BA.1 subvariant–specific vaccine (NVX-CoV2515) was tested alone or as a bivalent preparation with the prototype vaccine (NVX-CoV2373) to assess antibody responses to SARS-CoV-2. Methods Participants aged 18 to 64 years immunized with 3 doses of prototype mRNA vaccines were randomized 1:1:1 to receive a single dose of NVX-CoV2515, NVX-CoV2373, or the bivalent mixture in a phase 3 study investigating heterologous boosting with SARS-CoV-2 recombinant spike protein vaccines. Immunogenicity was measured 14 and 28 days after vaccination for the SARS-CoV-2 Omicron BA.1 sublineage and ancestral strain. Safety profiles of vaccines were assessed. Results Of participants who received trial vaccine (N = 829), those administered NVX-CoV2515 (n = 286) demonstrated a superior neutralizing antibody response to BA.1 vs NVX-CoV2373 (n = 274) at day 14 (geometric mean titer ratio, 1.6; 95% CI, 1.33–2.03). Seroresponse rates were 73.4% (91/124; 95% CI, 64.7–80.9) for NVX-CoV2515 vs 50.9% (59/116; 95% CI, 41.4–60.3) for NVX-CoV2373. All formulations were similarly well tolerated. Conclusions NVX-CoV2515 elicited a superior neutralizing antibody response against the Omicron BA.1 subvariant as compared with NVX-CoV2373 when administered as a fourth dose. Safety data were consistent with the established safety profile of NVX-CoV2373. Clinical Trials Registration ClinicalTrials.gov (NCT05372588). [ABSTRACT FROM AUTHOR]

Published
2024
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12. Immunogenicity and safety of a bivalent (omicron BA.5 plus ancestral) SARS-CoV-2 recombinant spike protein vaccine as a heterologous booster dose: interim analysis of a phase 3, non-inferiority, randomised, clinical trial

Author

Bennett, Chijioke, primary, Woo, Wayne, additional, Bloch, Mark, additional, Cheung, King, additional, Griffin, Paul, additional, Mohan, Rahul, additional, Deshmukh, Sachin, additional, Arya, Mark, additional, Cumming, Oscar, additional, Neville, A Munro, additional, McCallum Pardey, Toni G, additional, Plested, Joyce S, additional, Cloney-Clark, Shane, additional, Zhu, Mingzhu, additional, Kalkeri, Raj, additional, Patel, Nita, additional, Marcheschi, Alex, additional, Swan, Jennifer, additional, Smith, Gale, additional, Cho, Iksung, additional, Glenn, Gregory M, additional, Walker, Robert, additional, Mallory, Raburn M, additional, Anderson, Anna, additional, Ang, Mary, additional, Barnes, Timothy, additional, Bassin, Michelle, additional, Bessey, Kate, additional, Bowler, Simon, additional, Bull, Sheetal, additional, Burr, Lucy, additional, Burton, Robert, additional, Byrne, Michelle, additional, Carroll, Robert, additional, Chee, Nicholas, additional, Choy, Aaron, additional, Clark, Malcolm, additional, Dalebout, Marije, additional, De Wet, Peter, additional, Deshmukh, Kshama, additional, Diez Alvarez, Sergio, additional, Douglas, Dominic, additional, Engelander, Jacqueline, additional, Evangelista, Carla, additional, Game, Stuart, additional, Glass, Noor, additional, Gunner, Elizabeth, additional, Han, Jennifer, additional, Harrison, Michael, additional, Hing Kiang, Jason Doong, additional, Hlaing, Thazin, additional, Joshi, Divyansh, additional, Joyce, Sheree, additional, Kaluhin, Karen, additional, Kavic, Milanka, additional, Kononov, Juliana, additional, Lee, Gary, additional, Lee, Wei-I, additional, Leelasena, Indika, additional, Leong, Esmond, additional, Lim, Ivan, additional, Lister, Graham, additional, Loh, Denissa, additional, Magdy, Mary, additional, Maggs, Callum, additional, Mammoottil, Amith, additional, McCarthy, Shannon, additional, McKay, Nicole, additional, Melek, Mariah, additional, Michael Barnett, Adrian, additional, Moore, Andrew, additional, Moore, Amanda, additional, Murdoch, Louise, additional, Napier-Flood, Fiona, additional, Narsai, Ushma, additional, Neville, Alexander, additional, Nguyen, Paul, additional, Odarchenko, Ekaterina, additional, Pardey, Toni, additional, Quan, Dick, additional, Ranagsinghe, Ushank, additional, Rasalam, Roy, additional, Rayar, Shiva, additional, Ruthnam, Gonasagaran Jay, additional, Seet, Pi, additional, Smith, Deon, additional, Srilakshmanan, Krishna, additional, Taggart, Angela, additional, Tiong, Florence, additional, Toh, Boon, additional, Ujvary, Eniko, additional, Wallace, Stephanie, additional, Wolf, Rebecca, additional, Wong, Ian, additional, Yoo, Hye, additional, and Young, Rhys, additional

Published
2024
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13. A Pseudovirus-Based Neutralization Assay for SARS-CoV-2 Variants: A Rapid, Cost-Effective, BSL-2–Based High-Throughput Assay Useful for Vaccine Immunogenicity Evaluation

Author

Cai, Zhaohui, primary, Kalkeri, Raj, additional, Zhu, Mingzhu, additional, Cloney-Clark, Shane, additional, Haner, Benjamin, additional, Wang, Mi, additional, Osman, Bahar, additional, Dent, Dominic, additional, Feng, Sheau-Line, additional, Longacre, Zach, additional, Glenn, Greg, additional, and Plested, Joyce S., additional

Published
2024
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14. Altered IgG4 Antibody Response to Repeated mRNA versus Recombinant Protein SARS-CoV-2 Vaccines

Author

Kalkeri, Raj, primary, Zhu, Mingzhu, additional, Cloney-Clark, Shane, additional, Plested, Joyce S., additional, Parekh, Anand, additional, Gorinson, Drew, additional, Cai, Rongman, additional, Mahato, Soham, additional, Ramanathan, Pradhipa, additional, Aurelia, L. Carissa, additional, Selva, Kevin John, additional, Marchese, Anthony M., additional, Fries, Louis, additional, Chung, Amy W., additional, and Dunkle, Lisa M., additional

Published
2024
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15. Altered IgG4 Antibody Response to Repeated mRNA versus Protein COVID Vaccines

Author

Kalkeri, Raj, primary, Zhu, Mingzhu, additional, Cloney-Clark, Shane, additional, Plested, Joyce S, additional, Parekh, Anand, additional, Gorinson, Drew, additional, Cai, Rongman, additional, Mahato, Soham, additional, Ramanathan, Pradhipa, additional, Aurelia, L. Carissa, additional, John Selva, Kevin, additional, Marchese, Anthony M., additional, Fries, Louis, additional, Chung, Amy W., additional, and Dunkle, Lisa M., additional

Published
2024
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16. NVX-CoV2373 vaccination induces functional SARS-CoV-2-specific [CD4.sup.+] and [CD8.sup.+] T cell responses

Author

Moderbacher, Carolyn Rydyznski, Kim, Christina, Mateus, Jose, Plested, Joyce, Zhu, Mingzhu, Cloney-Clark, Shane, Weiskopf, Daniela, Sette, Alessandro, Fries, Louis, Glenn, Gregory, and Crotty, Shane

Subjects
Novavax Inc. -- Product development, Biotechnology industry -- Product development, Tumor necrosis factor -- Analysis, Health care industry, Covovax (Vaccine) -- Dosage and administration
Abstract

NVX-CoV2373 is an adjuvanted recombinant full-length SARS-CoV-2 spike trimer protein vaccine demonstrated to be protective against COVID-19 in efficacy trials. Here we demonstrate that vaccinated individuals made [CD4.sup.+] T cell responses after 1 and 2 doses of NVX-CoV2373, and a subset of individuals made [CD8.sup.+] T cell responses. Characterization of the vaccine-elicited [CD8.sup.+] T cells demonstrated IFN-[gamma] production. Characterization of the vaccine-elicited [CD4.sup.+] T cells revealed both circulating T follicular helper (cTfh) cells and Th1 cells ([IFN-[gamma].sup.+], [TNF-[alpha].sup.+], and [IL-2.sup.+]) were detectable within 7 days of the primary immunization. Spike-specific [CD4.sup.+] T cells were correlated with the magnitude of the later SARS-CoV-2-neutralizing antibody titers, indicating that robust generation of [CD4.sup.+] T cells, capable of supporting humoral immune responses, may be a key characteristic of NVX-CoV2373 that utilizes Matrix-M adjuvant., Introduction The ongoing COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused immense morbidity and mortality. This global crisis has been met with an unprecedented surge [...]

Published
2022
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17. Validation of a Pseudovirus Neutralization Assay for Severe Acute Respiratory Syndrome Coronavirus 2: A High-Throughput Method for the Evaluation of Vaccine Immunogenicity.

Author

Cai, Zhaohui, Kalkeri, Raj, Wang, Mi, Haner, Benjamin, Dent, Dominic, Osman, Bahar, Skonieczny, Paul, Ross, Jeremy, Feng, Sheau-Line, Cai, Rongman, Zhu, Mingzhu, Cloney-Clark, Shane, and Plested, Joyce S.

Subjects
SARS-CoV-2, VACCINE immunogenicity, COVID-19, VACCINE trials, RESPIRATORY syncytial virus, SERUM
Abstract

The evaluation of coronavirus disease 2019 (COVID-19) vaccine immunogenicity remains essential as the severe acute respiratory syncytial virus 2 (SARS-CoV-2) pandemic continues to evolve and as additional variants emerge. Neutralizing antibodies are a known correlate of protection for SARS-CoV-2 vaccines. A pseudovirus neutralization (PNT) assay was developed and validated at Novavax Clinical Immunology Laboratories to allow for the detection of neutralizing antibodies in vaccine clinical trial sera. The PNT assay was precise, accurate, linear, and specific in measuring SARS-CoV-2 neutralization titers in human serum for ancestral strain and the Omicron subvariants BA.5 and XBB.1.5, with an overall geometric coefficient of variation of ≤43.4%, a percent relative bias within the expected range of −60% to 150%, and a linearity value of R2 > 0.98 for all three strains. This pseudovirus assay will be useful for the analysis of vaccine clinical trial samples to assess vaccine immunogenicity. Future work will focus on modifying the assay for emerging variants, including XBB.1.16, EG.5.1, BA.2.86, and any other variants that emerge in the ongoing pandemic. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Immunogenicity and Safety of Heterologous Omicron BA.1 and Bivalent SARS-CoV-2 Recombinant Spike Protein Booster Vaccines: A Phase 3 Randomized Clinical Trial

Author

Bennett, Chijioke, primary, Rivers, E Joy, additional, Woo, Wayne, additional, Bloch, Mark, additional, Cheung, King, additional, Griffin, Paul, additional, Mohan, Rahul, additional, Deshmukh, Sachin, additional, Arya, Mark, additional, Cumming, Oscar, additional, Neville, A Munro, additional, Pardey, Toni McCallum, additional, Plested, Joyce S, additional, Cloney-Clark, Shane, additional, Zhu, Mingzhu, additional, Kalkeri, Raj, additional, Patel, Nita, additional, Buchanan, Agi, additional, Marcheschi, Alex, additional, Swan, Jennifer, additional, Smith, Gale, additional, Cho, Iksung, additional, Glenn, Gregory M, additional, Walker, Robert, additional, and Mallory, Raburn M, additional

Published
2023
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19. Respiratory Syncytial Virus Vaccination During Pregnancy and Effects in Infants

Author

Madhi, Shabir A., Polack, Fernando P., Piedra, Pedro A., Munoz, Flor M., Trenholme, Adrian A., Simões, Eric A. F., Swamy, Geeta K., Agrawal, Sapeckshita, Ahmed, Khatija, August, Allison, Baqui, Abdullah H., Calvert, Anna, Chen, Janice, Cho, Iksung, Cotton, Mark F., Cutland, Clare L., Englund, Janet A., Fix, Amy, Gonik, Bernard, Hammitt, Laura, Heath, Paul T., de Jesus, Joanne N., Jones, Christine E., Khalil, Asma, Kimberlin, David W., Libster, Romina, Llapur, Conrado J., Lucero, Marilla, Pérez Marc, Gonzalo, Marshall, Helen S., Masenya, Masebole S., Martinón-Torres, Federico, Meece, Jennifer K., Nolan, Terry M., Osman, Ayman, Perrett, Kirsten P., Plested, Joyce S., Richmond, Peter C., Snape, Matthew D., Shakib, Julie H., Shinde, Vivek, Stoney, Tanya, Thomas, D. Nigel, Tita, Alan T., Varner, Michael W., Vatish, Manu, Vrbicky, Keith, Wen, Judy, Zaman, Khalequ, Zar, Heather J., Glenn, Gregory M., and Fries, Louis F.

Published
2021
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21. A Severe Acute Respiratory Syndrome Coronavirus 2 Anti-Spike Immunoglobulin G Assay: A Robust Method for Evaluation of Vaccine Immunogenicity Using an Established Correlate of Protection

Author

Zhu, Mingzhu, primary, Cloney-Clark, Shane, additional, Feng, Sheau-line, additional, Parekh, Anand, additional, Gorinson, Drew, additional, Silva, David, additional, Skonieczny, Paul, additional, Wilson, Adjele, additional, Kalkeri, Raj, additional, Woo, Wayne, additional, Cai, Miranda R., additional, Fries, Louis, additional, Glenn, Greg, additional, and Plested, Joyce S., additional

Published
2023
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22. Different dose regimens of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373) in younger and older adults: A phase 2 randomized placebo-controlled trial

Author

Formica, Neil, Mallory, Raburn, Albert, Gary, Robinson, Michelle, Plested, Joyce S., Cho, Iksung, Robertson, Andreana, Dubovsky, Filip, and Glenn, Gregory M.

Subjects
Drugs -- Dosage and administration, Recombinant proteins -- Testing -- Health aspects, Biological sciences
Abstract

Background NVX-CoV2373 is a recombinant severe acute respiratory coronavirus 2 (rSARS-CoV-2) nanoparticle vaccine composed of trimeric full-length SARS-CoV-2 spike glycoproteins and Matrix-M1 adjuvant. Methods and findings The phase 2 component of our randomized, placebo-controlled, phase 1 to 2 trial was designed to identify which dosing regimen of NVX-CoV2373 should move forward into late-phase studies and was based on immunogenicity and safety data through Day 35 (14 days after the second dose). The trial was conducted at 9 sites in Australia and 8 sites in the United States. Participants in 2 age groups (aged 18 to 59 and 60 to 84 years) were randomly assigned to receive either 1 or 2 intramuscular doses of 5-[mu]g or 25-[mu]g NVX-CoV2373 or placebo, 21 days apart. Primary endpoints were immunoglobulin G (IgG) anti-spike protein response, 7-day solicited reactogenicity, and unsolicited adverse events. A key secondary endpoint was wild-type virus neutralizing antibody response. After enrollment, 1,288 participants were randomly assigned to 1 of 4 vaccine groups or placebo, with 1,283 participants administered at least 1 study treatment. Of these, 45% were older participants 60 to 84 years. Reactogenicity was predominantly mild to moderate in severity and of short duration (median Conclusions The study confirmed the phase 1 findings that the 2-dose regimen of 5-[mu]g NVX-CoV2373 is highly immunogenic and well tolerated in younger adults. In addition, in older adults, the 2-dose regimen of 5 [mu]g was also well tolerated and showed sufficient immunogenicity to support its use in late-phase efficacy studies. Trial registration ClinicalTrials.gov NCT04368988., Author(s): Neil Formica *, Raburn Mallory, Gary Albert, Michelle Robinson, Joyce S. Plested, Iksung Cho, Andreana Robertson, Filip Dubovsky, Gregory M. Glenn, for the 2019nCoV-101 Study Group Introduction The coronavirus [...]

Published
2021
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23. Immunogenicity of NVX-CoV2373 in PREVENT-19: A Phase 3, Randomized, Placebo-Controlled Trial in Adults in the United States and Mexico

Author

Áñez, Germán, primary, Kotloff, Karen L, additional, Gay, Cynthia L., additional, Nelson, Joy, additional, Dunbar, Haoua, additional, Cloney-Clark, Shane, additional, McGarry, Alice, additional, Woo, Wayne, additional, Cho, Iksung, additional, Plested, Joyce S., additional, Glenn, Gregory M., additional, and Dunkle, Lisa M., additional

Published
2023
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25. Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study

Author

Kulkarni, Prasad S., primary, Kadam, Abhijit, additional, Godbole, Sheela, additional, Bhatt, Varsha, additional, Raut, Abhishek, additional, Kohli, Sunil, additional, Tripathi, Santanu, additional, Kulkarni, Praveen, additional, Ludam, Rakhi, additional, Prabhu, Madhav, additional, Bavdekar, Ashish, additional, Gogtay, Nithya J., additional, Meshram, Sushant, additional, Kadhiravan, Tamilarasu, additional, Kar, Sonali, additional, Narayana, D.H. Ashwath, additional, Samuel, Clarence, additional, Kulkarni, Govind, additional, Gaidhane, Abhay, additional, Sathyapalan, Dipu, additional, Raut, Sidram, additional, Hadda, Vijay, additional, Bhalla, Hira Lal, additional, Bhamare, Chetanraj, additional, Dharmadhikari, Abhijeet, additional, Plested, Joyce S., additional, Cloney-Clarke, Shane, additional, Zhu, Mingzhu, additional, Pryor, Melinda, additional, Hamilton, Stephanie, additional, Thakar, Madhuri, additional, Shete, Ashwini, additional, Gautam, Manish, additional, Gupta, Nivedita, additional, Panda, Samiran, additional, Shaligram, Umesh, additional, Poonawalla, Cyrus S., additional, Bhargava, Balram, additional, Gunale, Bhagwat, additional, Kapse, Dhananjay, additional, Kanitkar, Shubhangi A., additional, Kakrani, Arjun L., additional, Tripathy, Srikanth P., additional, Tilak, Abhijit V., additional, Dhamne, Akshay A., additional, Mirza, Shahzad Beg, additional, Athavale, Prachi V., additional, Bhowmik, Mandakini, additional, Ratnakar, Parag J., additional, Gupta, Subodh, additional, Deotale, Vijayshri, additional, Jain, Jyoti, additional, Kalantri, Ashwini, additional, Jain, Vineet, additional, Goyal, Nidhi, additional, Arya, Alok, additional, Rongsen-Chandola, Temsunaro, additional, Dasgupta, Shreyasi, additional, Periera, Pratibha, additional, A, Vanmathi, additional, Kawade, Anand, additional, Gondhali, Arunkumar, additional, Kudyar, Palvi, additional, Singh, Abhishek, additional, Yadav, Ravi, additional, Alexander, Alina, additional, Gunasekaran, Venugopalan, additional, Dineshbabu, Sekar, additional, Samantaray, P.C., additional, Ravish, H.S., additional, Kamra, Deepshikha, additional, Gaidhane, Shilpa, additional, Zahiruddin, Quazi Syed, additional, Moni, Merlin, additional, Kumar, Anil, additional, Dravid, Ameet, additional, Mohan, Anant, additional, Suri, Tejas, additional, Patel, Tejas K., additional, Kishore, Surekha, additional, Choche, Rahul, additional, Ghatage, Deepak, additional, and Salvi, Sugam, additional

Published
2023
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26. A randomized, controlled study to evaluate the safety and immunogenicity of a heterologous booster dose of an adjuvanted SARS CoV-2 recombinant spike protein vaccine in adults

Author

Kulkarni, Prasad, primary, Gunale, Bhagwat, additional, Kohli, Sunil, additional, Lalwani, Sanjay, additional, Tripathy, Srikanth, additional, Kar, Sonali, additional, Raut, Sidram, additional, Kulkarni, Praveen, additional, Apte, Aditi, additional, Bavdekar, Ashish, additional, Bhalla, Hira Lal, additional, Plested, Joyce, additional, Cloney-Clark, Shane, additional, Zhu, MingZhu, additional, Kalkeri, Raj, additional, Pryor, Melinda, additional, Hamilton, Stephanie, additional, Thakar, Madhuri, additional, Sannidhi, Ranga, additional, Baranwal, Punjita, additional, Bhamare, Chetanraj, additional, Dharmadhikari, Abhijeet, additional, Gupta, Manish, additional, Poonawalla, Cyrus, additional, Shaligram, Umesh, additional, and Kapse, Dhananjay, additional

Published
2023
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27. Severe Acute Respiratory Syndrome Coronavirus 2 Receptor (Human Angiotensin-Converting Enzyme 2) Binding Inhibition Assay: A Rapid, High-Throughput Assay Useful for Vaccine Immunogenicity Evaluation

Author

Plested, Joyce S., primary, Zhu, Mingzhu, additional, Cloney-Clark, Shane, additional, Massuda, Edmond, additional, Patel, Urvashi, additional, Klindworth, Andrew, additional, Massare, Michael J., additional, Cai, Rongman, additional, Fries, Louis, additional, Glenn, Greg, additional, and Kalkeri, Raj, additional

Published
2023
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28. Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373

Author

Alves, Katia, primary, Plested, Joyce S., additional, Galbiati, Shirley, additional, Chau, Gordon, additional, Cloney-Clark, Shane, additional, Zhu, Mingzhu, additional, Kalkeri, Raj, additional, Patel, Nita, additional, Smith, Kathy, additional, Marcheschi, Alex, additional, Pfeiffer, Susan, additional, McFall, Heather, additional, Smith, Gale, additional, Glenn, Gregory M., additional, Dubovsky, Filip, additional, and Mallory, Raburn M., additional

Published
2023
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30. 2142. Safety and immunogenicity of COVID Influenza Combination Vaccine

Author

Shinde, Vivek, primary, Woo, Wayne, additional, Liu, Sharon, additional, Cook, Sara, additional, Santiago, Zenaida, additional, Neal, Susan, additional, Plested, Joyce S, additional, Vincent, Tim, additional, Zhu, Mingzhu, additional, Cloney-Clark, Shane, additional, Cho, Iksung, additional, Fries, Lou, additional, and Glenn, Greg, additional

Published
2022
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31. Immunogenicity and safety of a 4thhomologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): a phase 2, randomized, placebo-controlled trial

Author

Alves, Katia, primary, Plested, Joyce S, additional, Galbiati, Shirley, additional, Chau, Gordon, additional, Cloney-Clark, Shane, additional, Zhu, Mingzhu, additional, Kalkeri, Raj, additional, Patel, Nita, additional, Smith, Kathy, additional, Marcheschi, Alex, additional, Pfeiffer, Susan, additional, McFall, Heather, additional, Smith, Gale, additional, Glenn, Gregory M., additional, Dubovsky, Filip, additional, and Mallory, Raburn M., additional

Published
2022
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32. Safety and immunogenicity following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): a secondary analysis of a randomised, placebo-controlled, phase 2 trial

Author

Mallory, Raburn M, primary, Formica, Neil, additional, Pfeiffer, Susan, additional, Wilkinson, Bethanie, additional, Marcheschi, Alex, additional, Albert, Gary, additional, McFall, Heather, additional, Robinson, Michelle, additional, Plested, Joyce S, additional, Zhu, Mingzhu, additional, Cloney-Clark, Shane, additional, Zhou, Bin, additional, Chau, Gordon, additional, Robertson, Andreana, additional, Maciejewski, Sonia, additional, Hammond, Holly L, additional, Baracco, Lauren, additional, Logue, James, additional, Frieman, Matthew B, additional, Smith, Gale, additional, Patel, Nita, additional, Glenn, Gregory M, additional, Adams, Mark, additional, Arya, Mark, additional, Athan, Eugene, additional, Berger, Ira, additional, Bradley, Paul, additional, Briskin, Toby, additional, Glover II, Richard, additional, Griffin, Paul, additional, Kim, Joshua, additional, Kitchener, Scott, additional, Klein, Terry, additional, Leah, Amber, additional, Leelasena, Indika, additional, Lemech, Charlotte, additional, Lickliter, Jason, additional, Manning, Mary Beth, additional, Napier-Flood, Fiona, additional, Nugent, Paul, additional, Thackwray, Susan, additional, and Turner, Mark, additional

Published
2022
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34. Strong CD4+ T-Cell Responses to Ancestral and Variant Spike Proteins Are Established by NVX-CoV2373 Severe Acute Respiratory Syndrome Coronavirus 2 Primary Vaccination.

Author

Fries, Louis, Formica, Neil, Mallory, Raburn M, Zhou, Haixia, Plested, Joyce S, Kalkeri, Raj, Moldovan, Ioana, Patel, Nita, Albert, Gary, Robinson, Michelle, Cho, Iksung, Chau, Gordon, Dubovsky, Filip, Glenn, Gregory M, and Group, for the 2019nCoV-101 Study

Subjects
SARS-CoV-2, COVID-19, COVID-19 vaccines, T cells, GLYCOPROTEINS
Abstract

Background NVX-CoV2373 is an efficacious coronavirus disease 2019 (COVID-19) vaccine comprising full-length recombinant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (rS) glycoprotein and Matrix-M adjuvant. Phase 2 of a randomized, placebo-controlled, phase 1/2 trial in healthy adults (18–84 years of age) previously reported good safety/tolerability and robust humoral immunogenicity. Methods Participants were randomized to placebo or 1 or 2 doses of 5-µg or 25-µg rS with 50 µg Matrix-M adjuvant 21 days apart. CD4+ T-cell responses to SARS-CoV-2 intact S or pooled peptide stimulation (with ancestral or variant S sequences) were measured via enzyme-linked immunosorbent spot assay and intracellular cytokine staining. Results A clearly discernable spike antigen-specific CD4+ T-cell response was induced after 1 dose, but markedly enhanced after 2 doses. Counts and fold increases in cells producing Th1 cytokines exceeded those secreting Th2 cytokines, although both phenotypes were clearly present. Interferon-γ responses to rS were detected in 93.5% of 2-dose 5-µg recipients. A polyfunctional CD4+ T-cell response was cross-reactive and of equivalent magnitude to all tested variants, including Omicron BA.1/BA.5. Conclusions NVX-CoV2373 elicits a moderately Th1-biased CD4+ T-cell response that is cross-reactive with ancestral and variant S proteins after 2 doses. Clinical Trials Registration NCT04368988. [ABSTRACT FROM AUTHOR]

Published
2023
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35. Safety and Immunogenicity of SARS-CoV-2 Recombinant Spike Protein Vaccine in Children and Adolescents in India: A Phase 2-3 Randomized Clinical Trial.

Author

Gunale, Bhagwat, Kapse, Dhananjay, Kar, Sonali, Bavdekar, Ashish, Kohli, Sunil, Lalwani, Sanjay, Meshram, Sushant, Raut, Abhishek, Kulkarni, Praveen, Samuel, Clarence, Munshi, Renuka, Gupta, Madhu, Plested, Joyce S., Cloney-Clark, Shane, Zhu, MingZhu, Pryor, Melinda, Hamilton, Stephanie, Thakar, Madhuri, Shete, Ashwini, and Dharmadhikari, Abhijeet

Published
2023
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36. Safety, Immunogenicity and Efficacy of NVX-CoV2373 in Adolescents in PREVENT-19: A Randomized, Phase 3 Trial

Author

Áñez, Germán, Dunkle, Lisa M., Gay, Cynthia L., Kotloff, Karen L., Adelglass, Jeffrey M., Essink, Brandon, Campbell, James D., Cloney-Clark, Shane, Zhu, Mingzhu, Plested, Joyce S., Roychoudhury, Pavitra, Greninger, Alexander L., Patel, Nita, McGarry, Alice, Woo, Wayne, Cho, Iksung, Glenn, Gregory M., and Dubovsky, Filip

Subjects
Article
Abstract

BACKGROUNDOver 20% of cases and 0.4% of deaths from Covid-19 occur in children. Following demonstration of safety and efficacy of the adjuvanted, recombinant spike protein vaccine NVX-CoV2373 in adults, the PREVENT-19 trial enrolled adolescents.METHODSSafety, immunogenicity, and efficacy of NVX-CoV2373 were evaluated in adolescents aged 12 to RESULTSAmong 2,247 participants randomized between April–June 2021, 1,491 were allocated to NVX-CoV2373 and 756 to placebo. Post-vaccination, the ratio of NA geometric mean titers in adolescents compared to young adults was 1.5 (95% confidence interval [CI] 1.3 to 1.7). Twenty Covid-19 cases (all mild) occurred: 6 among NVX-CoV2373 and 14 among placebo recipients (vaccine efficacy [VE]: 79.5%, 95% CI, 46.8 to 92.1). All sequenced viral genomes (11/20) were identified as Delta variant (Delta variant VE: 82.0% [95% CI: 32.4 to 95.2]). Reactogenicity was largely mild-to-moderate, transient, and more frequent in NVX-CoV2373 recipients and after the second dose. Serious adverse events were rare and evenly distributed between treatments.CONCLUSIONSNVX-CoV2373 was safe, immunogenic, and efficacious in the prevention of Covid-19 and those cases caused by the Delta variant in adolescents.(Funded by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health; PREVENT-19 ClinicalTrials.gov number, NCT04611802).

Published
2022

37. Immunogenicity and safety of a fourth homologous dose of NVX-CoV2373.

Author

Alves, Katia, Plested, Joyce S., Galbiati, Shirley, Chau, Gordon, Cloney-Clark, Shane, Zhu, Mingzhu, Kalkeri, Raj, Patel, Nita, Smith, Kathy, Marcheschi, Alex, Pfeiffer, Susan, McFall, Heather, Smith, Gale, Glenn, Gregory M., Dubovsky, Filip, and Mallory, Raburn M.

Subjects
*SARS-CoV-2, *COVID-19 vaccines, *IMMUNE response, *SARS-CoV-2 Delta variant, *SARS-CoV-2 Omicron variant, *IMMUNOGLOBULINS
Abstract

• A fourth dose of NVX-CoV2373 did not increase local/systemic reactogenicity. • A fourth dose of NVX-CoV2373 enhanced immune response to SARS-CoV-2 variants. • An NVX-CoV2373 fourth dose induced robust immunogenicity in those aged 18–84 years. • Correlates of protection imply post-boost efficacy of ≥ 82% for Omicron variants. The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants has significantly reduced the efficacy of some approved vaccines. A fourth dose of NVX-CoV2373 (5 µg SARS-CoV-2 recombinant spike [rS] protein + 50 µg Matrix-M™ adjuvant; Novavax, Gaithersburg, MD) was evaluated to determine induction of cross-reactive antibodies to variants of concern. A phase II randomized study (NCT04368988) recruited participants in Australia and the United States to assess a primary series of NVX-CoV2373 followed by two booster doses (third and fourth doses at 6-month intervals) in adults 18–84 years of age. The primary series was administered when the SARS-CoV-2 ancestral strain was prevalent and the third and fourth doses while the Alpha and Delta variants were prevalent in AUS and US. Local/systemic reactogenicity was assessed the day of vaccination and for 6 days thereafter. Unsolicited adverse events (AEs) were reported. Immunogenicity was measured before, and 14 days after, fourth dose administration, using anti-spike serum immunoglobulin G (IgG) and neutralization assays against ancestral SARS-CoV-2 strain and Omicron sublineages. Among 1283 enrolled participants, 258 were randomized to receive the two-dose primary series, of whom 104 received a third dose, and 45 received a fourth dose of NVX-CoV2373. The incidence of local/systemic reactogenicity events increased after the first three doses of NVX-CoV2373 and leveled off after dose 4. Unsolicited AEs were reported in 9 % of participants after dose 4 (none of which were severe or serious). Anti-rS IgG levels and neutralization antibody titers increased following booster doses to a level approximately four-fold higher than that observed after the primary series, with a progressively narrowed gap in response between the ancestral strain and Omicron BA.5. A fourth dose of NVX-CoV2373 enhanced immunogenicity for ancestral and variant SARS-CoV-2 strains without increasing reactogenicity, indicating that updates to the vaccine composition may not be currently warranted. [ABSTRACT FROM AUTHOR]

Published
2023
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38. Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial

Author

Toback, Seth, primary, Galiza, Eva, additional, Cosgrove, Catherine, additional, Galloway, James, additional, Goodman, Anna L, additional, Swift, Pauline A, additional, Rajaram, Sankarasubramanian, additional, Graves-Jones, Alison, additional, Edelman, Jonathan, additional, Burns, Fiona, additional, Minassian, Angela M, additional, Cho, Iksung, additional, Kumar, Lakshmi, additional, Plested, Joyce S, additional, Rivers, E Joy, additional, Robertson, Andreana, additional, Dubovsky, Filip, additional, Glenn, Greg, additional, Heath, Paul T, additional, Soiza, Roy L., additional, Brittain-Long, Robin, additional, Scicluna, Chiara, additional, Edwards, Carole, additional, Mackay, Lynn, additional, D'Allesandro, Mariella, additional, Nicol, Amy, additional, Norris, Karen, additional, Mann, Sandra, additional, Lawrence, Heather, additional, Valentine, Ruth, additional, Viljoen, Marianne Elizabeth, additional, Pretswell, Carol H., additional, Nicholls, Helen, additional, Munsoor, Imrozia, additional, Meyrick, Agnieszka, additional, Kyriakidou, Christina, additional, Iyengar, Shalini, additional, Jamal, Arham, additional, Richards, Nick, additional, Price, Helen, additional, Rowbotham, Bridie, additional, Bird, Danielle, additional, Smith, Karen, additional, Littler, Olga, additional, Fielding, Kirsty, additional, Townsend-Rose, Anna, additional, Miller, Karen, additional, Davis, Jessica, additional, Elliot-Garwood, Alison, additional, Trottier, Lauren, additional, Edwards, Paul, additional, McFarland, Margaret, additional, Osanlou, Orod, additional, Longshaw, Laura, additional, Stockport, Jane, additional, Grundy, Lynne, additional, Broad, Katharine Lucy, additional, Regan, Karen, additional, Storton, Kim, additional, Ryan-Wakeling, Declan, additional, Wilson, Brad, additional, Munisamy, Malathy, additional, Wright, John, additional, Shenoy, Anil, additional, English, Beverley, additional, Brear, Lucy, additional, Cicconi, Paola, additional, Boffito, Marta, additional, Milinkovic, Ana, additional, Byrne, Ruth, additional, Movahedi, Roya, additional, Housman, Rosalie, additional, Kara, Naveed, additional, Brown, Ellen, additional, Cipriani, Andrea, additional, Attenburrow, Mary-Jane, additional, Smith, Katharine A., additional, Packham, Jonathan, additional, Sparrow, Geoff, additional, Smith, Richard, additional, Rosier, Josephine M., additional, Saja, Khalid, additional, Nago, Nyasha, additional, Camilleri, Brian, additional, Immanuel, Anita, additional, Hamblin, Mike, additional, Osagie, Rawlings, additional, Mohan, Mahalakshmi, additional, Floyd, Hilary, additional, Goddard, Suzanne, additional, Mutgi, Sanjay, additional, Evans, John, additional, McKeon, Sean, additional, Vilimiene, Neringa, additional, Chicano, Rosavic, additional, Hayre, Rachel, additional, Pandaan, Alice, additional, Henshall, Catherine, additional, Serrano, Sonia, additional, Mazzella, Andrea, additional, Rajeswaran, Thurkka, additional, Mathew, Moncy, additional, Bisnauthsing, Karen, additional, Bremner, Laura, additional, Fok, Henry, additional, Morselli, Franca, additional, Cinardo, Paola, additional, Merrick, Blair, additional, Sowole, Lucy, additional, Broadhead, Samantha, additional, Palmer, Natalie, additional, Cordle, Jessica, additional, Goldsmith, Jaimie Wilson, additional, Cooney, Enya, additional, Jackson, Beth, additional, Jayatilleke, Thilina, additional, Cheng, Zelda, additional, Helliwell, Toby, additional, Chudyk, Adrian, additional, Giemza, Rafaela, additional, Villajin, John Lord, additional, Yogo, Noah, additional, Makanju, Esther, additional, Dulawan, Pearl, additional, Nagra, Deepak, additional, Buazon, April, additional, Russell, Alice, additional, Bird, Georgie, additional, Heer, Amardeep, additional, Sarmiento, Rex, additional, Sanghera, Balraj, additional, Mullin, Melanie, additional, Champion, Adam, additional, Bevan, Aisling, additional, Iqbal, Kinzah, additional, Johnson, Alshia, additional, Clark, Rebecca, additional, Shaw, Sarah, additional, Shaw, Steven, additional, Chalk, Amanda, additional, Lovatt, Martin, additional, Lillicrap, Caroline, additional, Parker, Angela, additional, Hansel, Jan, additional, Wong, Zhi, additional, Gan, Galvin, additional, Tuma, Eyad, additional, Minton, Jane, additional, Murira, Jennifer, additional, Saman, Razan, additional, Hall, Alistair, additional, Holliday, Kyra, additional, Khan, Zara, additional, Calderwood, James, additional, Twigg, George, additional, Baker, Helena, additional, Corrigan, Julie, additional, Houseman, Katy, additional, Raguvanshi, Subhra, additional, Heining, Dominic, additional, Weddell, Jake, additional, Glaves, Liz, additional, Thompson, Kim, additional, Davies, Francis, additional, Lambley Burke, Ruth, additional, Thomson, Emma C., additional, Saralaya, Dinesh, additional, Berry, Lisa, additional, Hopewell, Nancy, additional, Gerdes, Leigh, additional, Pacurar, Mihaela, additional, Faust, Saul N., additional, Turner, Jeremy, additional, Jeanes, Christopher, additional, Cooper, Adele, additional, Keshet-Price, Jocelyn, additional, Coke, Lou, additional, Cambell-Kelly, Melissa, additional, Dhatariya, Ketan, additional, Williams, Claire, additional, Marks, Georgina, additional, Sudbury, James, additional, Rodolico, Lisa, additional, Bradley, Judy, additional, Carr, Sharon, additional, Martin, Roisin, additional, Madden, Angelina, additional, Biagioni, Paul, additional, McKenna, Sonia, additional, Clinton, Alison, additional, O'Kane, Maurice, additional, Carter, Justin, additional, Dewhurst, Matthew, additional, Wetherill, Bill, additional, Hoggarth, Thandiwe, additional, Collins, Katrina Lennon, additional, Chowdhury, Marie, additional, Nathoo, Adil, additional, Heinen, Anna, additional, MacDonald, Orla, additional, Hurducas, Claudia, additional, Cifuentes, Liliana, additional, Gill, Harjeevan, additional, Gibson, Andy, additional, West, Raha, additional, Ewing, Jane, additional, Blacow, Rachel, additional, Haughney, John, additional, MacDonald, Jonathan, additional, Seenan, John Paul, additional, Webb, Stewart, additional, O'Leary, Colin, additional, Muir, Scott, additional, White, Beth, additional, Ritchie, Neil, additional, McAuley, Daniel F., additional, Stewart, Jonathan, additional, D'Alessandro, Mariella, additional, Lakeman, Nicki, additional, Purandare, Laura, additional, Browne, Duncan, additional, Tucker, David, additional, Luck, Peter, additional, Everden, Angharad, additional, Trembath, Lisa, additional, Visick, Michael, additional, Morley, Nick, additional, Reid, Laura, additional, Chenoweth, Helen, additional, Maclean, Kirsty, additional, Sheridan, Ray P., additional, Burden, Tom, additional, Lunt, Craig Francis, additional, Todd, Shirley, additional, Estcourt, Stephanie, additional, Pearce, Jasmine Marie, additional, Wilkins, Suzanne, additional, Love-Rouse, Cathryn, additional, Torok-Pollok, Eva, additional, Youle, Mike, additional, Madge, Sara, additional, Solomon, Danielle, additional, Nandani, Aarti, additional, North, Janet M., additional, Hemat, Nargis, additional, Newport, Rachel, additional, Kalra, Philip A., additional, Chukwu, Chukwuma, additional, Wickens, Olivia, additional, O'Loughlin, Vikki, additional, Mistry, Hema, additional, Harrison, Louise, additional, Oliver, Robert, additional, Peers, Anne-Marie, additional, Zadik, Jess, additional, Doyle, Katie, additional, Chadwick, David R., additional, Colling, Kerry, additional, Wroe, Caroline, additional, Branch, Marie, additional, Chilvers, Alison, additional, Essex, Sarah, additional, Stone, Mark, additional, San Francisco Ramos, Alberto, additional, Beales, Emily, additional, Bird, Olivia, additional, Danos, Zsofia, additional, Fofie, Hazel, additional, Hultin, Cecilia, additional, Ikram, Sabina, additional, Mabesa, Fran, additional, Mescall, Aoife, additional, Pereira, Josyanne, additional, Pearce, Jennifer, additional, Sutton, Natalina, additional, Snashall, Emma, additional, Baxter, David Neil, additional, Bennett, Sara, additional, Suggitt, Debbie, additional, Hughes, Kerry, additional, Woodyatt, Wiesia, additional, Beacon, Lynsey, additional, Kent, Alissa, additional, Cooper, Chris, additional, Rudic, Milan, additional, Tunstall, Simon, additional, Jackson, Matthew, additional, Hombersley, Claire, additional, Moore, Patrick, additional, Cutts, Rebecca, additional, Higham, Andrew, additional, Bukhari, Marwan, additional, Elnaggar, Mohamed, additional, Glover, Michelle, additional, Richardson, Fiona, additional, Dent, Alexandra, additional, Mirza, Shahzeb, additional, Ark, Rajiv, additional, Han, Jennie, additional, Hope, Suzy V., additional, Mitchelmore, Philip J., additional, Osanlou, Rostam, additional, Freedman, Andrew, additional, Cooper, Alison, additional, Burton, Katherine, additional, Katechia, Kashyap, additional, Barrett, Michael, additional, Salkeld, Jo, additional, Hill, Natalie, additional, Lee, Nathaniel, additional, Perkins, Jon, additional, and Fox, Polly, additional

Published
2022
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39. Safety and Immunogenicity of SII-NVX-CoV2373 (COVID-19 Vaccine) In Adults in a Phase 2/3, Observer-Blind, Randomised, Controlled Study

Author

Kulkarni, Prasad S., primary, Kadam, Abhijit, additional, Godbole, Sheela, additional, Bhatt, Varsha, additional, Raut, Abhishek, additional, Kohli, Sunil, additional, Tripathi, Santanu, additional, Kulkarni, Praveen, additional, Ludam, Rakhi, additional, Prabhu, Madhav, additional, Bavdekar, Ashish, additional, Gogtay, Nithya J., additional, Meshram, Sushant, additional, Kadhiravan, Tamilarasu, additional, Kar, Sonali, additional, Narayana, Ashwath, additional, Samuel, Clarence, additional, Kulkarni, Govind, additional, Gaidhane, Abhay, additional, Sathyapalan, Dipu, additional, Raut, Sidram, additional, Hadda, Vijay, additional, Bhalla, Hira Lal, additional, Bhamare, Chetanraj, additional, Dharmadhikari, Abhijeet, additional, Plested, Joyce, additional, Cloney-Clarke, Shane, additional, Zhu, Mingzhu, additional, Pryor, Melinda, additional, Thakar, Madhuri, additional, Shete, Ashwini, additional, Gautam, Manish, additional, Gupta, Nivedita, additional, Panda, Samiran, additional, Shaligram, Umesh, additional, Poonawalla, Cyrus, additional, Bhargava, Balram, additional, Gunale, Bhagwat, additional, Kapse, Dhananjay, additional, and Study Group, for the COVOVAX, additional

Published
2022
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41. Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial

Author

Toback, Seth, Galiza, Eva, Cosgrove, Catherine, Galloway, James, Goodman, Anna L, Swift, Pauline A, Rajaram, Sankarasubramanian, Graves-Jones, Alison, Edelman, Jonathan, Burns, Fiona, Minassian, Angela M, Cho, Iksung, Kumar, Lakshmi, Plested, Joyce S, Rivers, E Joy, Robertson, Andreana, Dubovsky, Filip, Glenn, Greg, Heath, Paul T, Soiza, Roy L., Brittain-Long, Robin, Scicluna, Chiara, Edwards, Carole, Mackay, Lynn, D'Allesandro, Mariella, Nicol, Amy, Norris, Karen, Mann, Sandra, Lawrence, Heather, Valentine, Ruth, Viljoen, Marianne Elizabeth, Pretswell, Carol H., Nicholls, Helen, Munsoor, Imrozia, Meyrick, Agnieszka, Kyriakidou, Christina, Iyengar, Shalini, Jamal, Arham, Richards, Nick, Price, Helen, Rowbotham, Bridie, Bird, Danielle, Smith, Karen, Littler, Olga, Fielding, Kirsty, Townsend-Rose, Anna, Miller, Karen, Davis, Jessica, Elliot-Garwood, Alison, Trottier, Lauren, Edwards, Paul, McFarland, Margaret, Osanlou, Orod, Longshaw, Laura, Stockport, Jane, Grundy, Lynne, Broad, Katharine Lucy, Regan, Karen, Storton, Kim, and Ryan-Wakeling, Declan

Abstract

Background: Safety and immunogenicity of COVID-19 vaccines when co-administered with influenza vaccines have not yet been reported. Methods: A sub-study on influenza vaccine co-administration was conducted as part of the phase 3 randomised trial of NVX-CoV2373’s safety and efficacy; ~400 participants meeting main study entry criteria, with no contraindications to influenza vaccination, were enroled. After randomisation to receive NVX-CoV2373 or placebo, sub-study participants received an open-label influenza vaccine at the same time as the first dose of NVX-CoV2373. Reactogenicity was evaluated for 7 days post-vaccination plus monitoring for unsolicited adverse events (AEs), medically-attended AEs (MAAEs), and serious AEs (SAEs). Vaccine efficacy against COVID-19 was assessed. Findings: Sub-study participants were younger (median age 39; 6.7 % ≥65 years), more racially diverse, and had fewer comorbid conditions than main study participants. Reactogenicity events more common in co-administration group included tenderness (70.1% vs 57.6%) or pain (39.7% vs 29.3%) at injection site, fatigue (27.7% vs 19.4%), and muscle pain (28.3% vs 21.4%). Rates of unsolicited AEs, MAAEs, and SAEs were low and balanced between the two groups. Co-administration resulted in no change to influenza vaccine immune response, while a reduction in antibody responses to the NVX-CoV2373 vaccine was noted. Vaccine efficacy against COVID-19 was 87.5% (95% CI: -0.2, 98.4) in those 18

Published
2021

43. Safety, Immunogenicity, and Efficacy of a COVID-19 Vaccine (NVX-CoV2373) Co-administered With Seasonal Influenza Vaccines

Author

Toback, Seth, primary, Galiza, Eva, additional, Cosgrove, Catherine, additional, Galloway, James, additional, Goodman, Anna L., additional, Swift, Pauline A., additional, Rajaram, Sankarasubramanian, additional, Graves-Jones, Alison, additional, Edelman, Jonathan, additional, Burns, Fiona, additional, Minassian, Angela M., additional, Cho, Iksung, additional, Kumar, Lakshmi, additional, Plested, Joyce S., additional, Rivers, E. Joy, additional, Robertson, Andreana, additional, Dubovsky, Filip, additional, Glenn, Greg, additional, and Heath, Paul T., additional

Published
2021
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44. Immunogenicity and In vivo protection of a variant nanoparticle vaccine that confers broad protection against emerging SARS-CoV-2 variants

Author

Logue, James, primary, Johnson, Robert, additional, Patel, Nita, additional, Zhou, Bin, additional, Maciejewski, Sonia, additional, Zhou, Haixia, additional, Portnoff, Alyse, additional, Tian, Jing-Hui, additional, McGrath, Marisa, additional, Haupt, Robert, additional, Weston, Stuart, additional, Hammond, Holly, additional, Guebre-Xabier, Mimi, additional, Dillen, Carly, additional, Plested, Joyce, additional, Cloney-Clark, Shane, additional, Greene, Ann M, additional, Massare, Mike, additional, Glenn, Greg, additional, Smith, Gale, additional, and Frieman, Matthew, additional

Published
2021
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45. Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant

Author

Shinde, Vivek, primary, Bhikha, Sutika, additional, Hoosain, Zaheer, additional, Archary, Moherndran, additional, Bhorat, Qasim, additional, Fairlie, Lee, additional, Lalloo, Umesh, additional, Masilela, Mduduzi S.L., additional, Moodley, Dhayendre, additional, Hanley, Sherika, additional, Fouche, Leon, additional, Louw, Cheryl, additional, Tameris, Michele, additional, Singh, Nishanta, additional, Goga, Ameena, additional, Dheda, Keertan, additional, Grobbelaar, Coert, additional, Kruger, Gertruida, additional, Carrim-Ganey, Nazira, additional, Baillie, Vicky, additional, de Oliveira, Tulio, additional, Lombard Koen, Anthonet, additional, Lombaard, Johan J., additional, Mngqibisa, Rosie, additional, Bhorat, As’ad E., additional, Benadé, Gabriella, additional, Lalloo, Natasha, additional, Pitsi, Annah, additional, Vollgraaff, Pieter-Louis, additional, Luabeya, Angelique, additional, Esmail, Aliasgar, additional, Petrick, Friedrich G., additional, Oommen-Jose, Aylin, additional, Foulkes, Sharne, additional, Ahmed, Khatija, additional, Thombrayil, Asha, additional, Fries, Lou, additional, Cloney-Clark, Shane, additional, Zhu, Mingzhu, additional, Bennett, Chijioke, additional, Albert, Gary, additional, Faust, Emmanuel, additional, Plested, Joyce S., additional, Robertson, Andreana, additional, Neal, Susan, additional, Cho, Iksung, additional, Glenn, Greg M., additional, Dubovsky, Filip, additional, and Madhi, Shabir A., additional

Published
2021
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46. Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine

Author

Keech, Cheryl, primary, Albert, Gary, additional, Cho, Iksung, additional, Robertson, Andreana, additional, Reed, Patricia, additional, Neal, Susan, additional, Plested, Joyce S., additional, Zhu, Mingzhu, additional, Cloney-Clark, Shane, additional, Zhou, Haixia, additional, Smith, Gale, additional, Patel, Nita, additional, Frieman, Matthew B., additional, Haupt, Robert E., additional, Logue, James, additional, McGrath, Marisa, additional, Weston, Stuart, additional, Piedra, Pedro A., additional, Desai, Chinar, additional, Callahan, Kathleen, additional, Lewis, Maggie, additional, Price-Abbott, Patricia, additional, Formica, Neil, additional, Shinde, Vivek, additional, Fries, Louis, additional, Lickliter, Jason D., additional, Griffin, Paul, additional, Wilkinson, Bethanie, additional, and Glenn, Gregory M., additional

Published
2020
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47. Induction of Cross-Reactive Hemagglutination Inhibiting Antibody and Polyfunctional CD4+ T-Cell Responses by a Recombinant Matrix-M–Adjuvanted Hemagglutinin Nanoparticle Influenza Vaccine

Author

Shinde, Vivek, primary, Cai, Rongman, additional, Plested, Joyce, additional, Cho, Iksung, additional, Fiske, Jamie, additional, Pham, Xuan, additional, Zhu, Mingzhu, additional, Cloney-Clark, Shane, additional, Wang, Nan, additional, Zhou, Haixia, additional, Zhou, Bin, additional, Patel, Nita, additional, Massare, Michael J, additional, Fix, Amy, additional, Spindler, Michelle, additional, Thomas, David Nigel, additional, Smith, Gale, additional, Fries, Louis, additional, and Glenn, Gregory M, additional

Published
2020
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48. Comparison of the Safety and Immunogenicity of a Novel Matrix-M-adjuvanted Nanoparticle Influenza Vaccine with a Quadrivalent Seasonal Influenza Vaccine in Older Adults: A Randomized Controlled Trial

Author

Shinde, Vivek, primary, Cho, Iksung, additional, Plested, Joyce S., additional, Agrawal, Sapeckshita, additional, Fiske, Jamie, additional, Cai, Rongman, additional, Zhou, Haixia, additional, Pham, Xuan, additional, Zhu, Mingzhu, additional, Cloney-Clark, Shane, additional, Wang, Nan, additional, Zhou, Bin, additional, Lewis, Maggie, additional, Price-Abbott, Patty, additional, Patel, Nita, additional, Massare, Michael J, additional, Smith, Gale, additional, Keech, Cheryl, additional, Fries, Louis, additional, and Glenn, Gregory M, additional

Published
2020
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49. First-in-Human Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine

Author

Keech, Cheryl, primary, Glenn, Gregory M., additional, Albert, Gary, additional, Cho, Iksung, additional, Robertson, Andreana, additional, Reed, Patricia, additional, Neal, Susan, additional, Plested, Joyce S., additional, Zhu, Mingzhu, additional, Cloney-Clark, Shane, additional, Zhou, Haixia, additional, Smith, Gale, additional, Patel, Nita, additional, Frieman, Matthew B., additional, Haupt, Robert E., additional, Logue, James, additional, McGrath, Marisa, additional, Weston, Stuart, additional, Piedra, Pedro A., additional, Desai, Chinar, additional, Callahan, Kathleen, additional, Lewis, Maggie, additional, Price-Abbott, Patricia, additional, Formica, Neil, additional, Shinde, Vivek, additional, Fries, Louis, additional, Lickliter, Jason D., additional, Griffin, Paul, additional, and Wilkinson, Bethanie, additional

Published
2020
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50. Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants

Author

Madhi, Shabir A., primary, Polack, Fernando P., additional, Piedra, Pedro A., additional, Munoz, Flor M., additional, Trenholme, Adrian A., additional, Simões, Eric A.F., additional, Swamy, Geeta K., additional, Agrawal, Sapeckshita, additional, Ahmed, Khatija, additional, August, Allison, additional, Baqui, Abdullah H., additional, Calvert, Anna, additional, Chen, Janice, additional, Cho, Iksung, additional, Cotton, Mark F., additional, Cutland, Clare L., additional, Englund, Janet A., additional, Fix, Amy, additional, Gonik, Bernard, additional, Hammitt, Laura, additional, Heath, Paul T., additional, de Jesus, Joanne N., additional, Jones, Christine E., additional, Khalil, Asma, additional, Kimberlin, David W., additional, Libster, Romina, additional, Llapur, Conrado J., additional, Lucero, Marilla, additional, Pérez Marc, Gonzalo, additional, Marshall, Helen S., additional, Masenya, Masebole S., additional, Martinón-Torres, Federico, additional, Meece, Jennifer K., additional, Nolan, Terry M., additional, Osman, Ayman, additional, Perrett, Kirsten P., additional, Plested, Joyce S., additional, Richmond, Peter C., additional, Snape, Matthew D., additional, Shakib, Julie H., additional, Shinde, Vivek, additional, Stoney, Tanya, additional, Thomas, D. Nigel, additional, Tita, Alan T., additional, Varner, Michael W., additional, Vatish, Manu, additional, Vrbicky, Keith, additional, Wen, Judy, additional, Zaman, Khalequ, additional, Zar, Heather J., additional, Glenn, Gregory M., additional, and Fries, Louis F., additional

Published
2020
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