Immunogenicity and safety of SARS-CoV-2 recombinant protein nanoparticle vaccine GBP510 adjuvanted with AS03: interim results of a randomised, active-controlled, observer-blinded, phase 3 trialResearch in context

Autor: Joon Young Song, Won Suk Choi, Jung Yeon Heo, Eun Jin Kim, Jin Soo Lee, Dong Sik Jung, Shin-Woo Kim, Kyung-Hwa Park, Joong Sik Eom, Su Jin Jeong, Jacob Lee, Ki Tae Kwon, Hee Jung Choi, Jang Wook Sohn, Young Keun Kim, Byung Wook Yoo, In-Jin Jang, Maria Z. Capeding, François Roman, Thomas Breuer, Piotr Wysocki, Lauren Carter, Sushant Sahastrabuddhe, Manki Song, Naveena D'Cor, Hun Kim, Ji Hwa Ryu, Su Jeen Lee, Yong Wook Park, Hee Jin Cheong, Agathe Philippot, Francesca Solmi, Maria Angeles Ceregido, Byoung-Shik Shim, Sang Hwan Seo, Simone D'Souza, Patchara Thaisrivichai, Josefina Carlos, Edison Alberto, Sorachai Nitayaphan, Winai Ratanasuwan, Piroon Mootsikapun, Romanee Chaiwarith, Luong Chan Quang, Olena Karpenko, Tatiana Yurkiv, Vitalii Kutovyi, Angela Bartko, Olga Gyrina, Olga Barna, Mykhailo Pugach, Claire Thurlow, Simon Carson, Susan Smith, Mike Williams, Tiwini Hemi Senior, Tim Humphrey, Davitt Sheahan, Hokeun Park, Yoon Yeong Lee, Seung Gu Kang

Publikováno v: EClinicalMedicine, Vol 64, Iss , Pp 102140- (2023)

Summary: Background: GBP510 vaccine contains self-assembling, recombinant nanoparticles displaying SARS-CoV-2 spike receptor-binding domains. We report interim phase 3 immunogenicity results for GBP510 adjuvanted with AS03 (GBP510/AS03) compared with

Externí odkaz: https://doaj.org/article/608a2ee1e423411eb689bce93946af34

Safety and immunogenicity of an AS03-adjuvanted plant-based SARS-CoV-2 vaccine in Adults with and without Comorbidities

Autor: Nathalie Charland, Philipe Gobeil, Stéphane Pillet, Iohann Boulay, Annie Séguin, Alexander Makarkov, Gretchen Heizer, Kapil Bhutada, Asif Mahmood, Sonia Trépanier, Karen Hager, Julia Jiang-Wright, Judith Atkins, Pooja Saxena, Matthew P. Cheng, Donald C. Vinh, Philippe Boutet, François Roman, Robbert Van Der Most, Maria Angeles Ceregido, Marc Dionne, Guy Tellier, Jean-Sébastien Gauthier, Brandon Essink, Michael Libman, Jason Haffizulla, André Fréchette, Marc-André D’Aoust, Nathalie Landry, Brian J. Ward

Publikováno v: npj Vaccines, Vol 7, Iss 1, Pp 1-13 (2022)

Abstract The rapid spread of SARS-CoV-2 continues to impact humanity on a global scale with rising total morbidity and mortality. Despite the development of several effective vaccines, new products are needed to supply ongoing demand and to fight var

Externí odkaz: https://doaj.org/article/b6a4cc5cfcb64d00803666e2639e3ffb

Safety and immunogenicity of a variant-adapted SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant as a booster in adults primed with authorized vaccines: a phase 3, parallel-group studyResearch in context

Autor: Guy de Bruyn, Joyce Wang, Annie Purvis, Martin Sanchez Ruiz, Haritha Adhikarla, Saad Alvi, Matthew I. Bonaparte, Daniel Brune, Agustin Bueso, Richard M. Canter, Maria Angeles Ceregido, Sachin Deshmukh, David Diemert, Adam Finn, Remi Forrat, Bo Fu, Julie Gallais, Paul Griffin, Marie-Helene Grillet, Owen Haney, Jeffrey A. Henderson, Marguerite Koutsoukos, Odile Launay, Federico Martinon Torres, Roger Masotti, Nelson L. Michael, Juliana Park, Doris Maribel Rivera-Medina, Natalya Romanyak, Chris Rook, Lode Schuerman, Lawrence D. Sher, Fernanda Tavares-Da-Silva, Ashley Whittington, Roman M. Chicz, Sanjay Gurunathan, Stephen Savarino, Saranya Sridhar, Allaw Mohammed, Babin Valérie, Babyak Jennifer, Ines Ben-Ghezala, Thomas Breuer, Corinne Breymeier, Anne Conrad, Ciarrah Holmqvist, Cristiana Costa-Araujo, Florence Coux, Christine Dellanno, Bertrand Dussol, Brandon Essink, Jesús Garrido, Pierre-Olivier Girodet, Claudia Gonzalez, Marie-Ange Grosbois, Justin Hammond, Chelsea He, Ciarrah Homlqvist, Kathy Hudzina, Mark Hutchens, Peta-Gay Jackson Booth, Arnel Joaquin, Rama Kandasamy, Jennifer Kasztejna, Michael Keefer, Murray Kimmel, Matthew Kresge, Fabrice Laine, Maeva Lefebvre, Denise Lopez, Malaborbor Perpetua Lourdes, Zoha Maakaroun-Vermesse, Caitlin Malishchak, Lisa Menard, Sandra Mendoza, Patrick Moore, Mounika Mulamalla, Patrick Mulholland, Jean-Francois Nicolas, Onyema Ogbuagu, Juan Ortiz, Ana Paula Perroud, Gina Peyton, Ya-Fen Purvis, Vanessa Raabe, Enrique Rivas, Nadine Rouphael, Beatrice Roy, Lola Sagot, Nessryne Sater, Howard Schwartz, Randall Severance, Jiayuan Shi, Magdalena Sobieszczyk, Charlene Stevens, Tran Phuong Thuy, Ramy Toma, Tina Tong, Sophie Tourneux, John Treanor, Núria Turet, Rachel Froget, Stephen Walsh, Judith White, Victor del Campo Perez, Lina Perez Breva, Pablo Rojo Conejo, Maria Belen Ruiz Antoraz, Toong Chin, Charlotte Fribbens, Adrian Phillipson, Rachel Kaminski, Stevan Emmett, Corey Hebert, Thomas Birch, Russell Roberson, Jeffrey Zacher, Sophie Gelu-Maury, Loron Loryne, Yvonne Davis

Publikováno v: EClinicalMedicine, Vol 62, Iss , Pp 102109- (2023)

Summary: Background: In a parallel-group, international, phase 3 study (ClinicalTrials.gov NCT04762680), we evaluated prototype (D614) and Beta (B.1.351) variant recombinant spike protein booster vaccines with AS03-adjuvant (CoV2 preS dTM-AS03). Meth

Externí odkaz: https://doaj.org/article/1e007f68a3a6477da53dae2f0eb41b2d

Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study

Autor: Saranya Sridhar, Arnel Joaquin, Matthew I Bonaparte, Agustin Bueso, Anne-Laure Chabanon, Aiying Chen, Roman M Chicz, David Diemert, Brandon J Essink, Bo Fu, Nicole A Grunenberg, Helene Janosczyk, Michael C Keefer, Doris M Rivera M, Ya Meng, Nelson L Michael, Sonal S Munsiff, Onyema Ogbuagu, Vanessa N Raabe, Randall Severance, Enrique Rivas, Natalya Romanyak, Nadine G Rouphael, Lode Schuerman, Lawrence D Sher, Stephen R Walsh, Judith White, Dalia von Barbier, Guy de Bruyn, Richard Canter, Marie-Helene Grillet, Maryam Keshtkar-Jahromi, Marguerite Koutsoukos, Denise Lopez, Roger Masotti, Sandra Mendoza, Catherine Moreau, Maria Angeles Ceregido, Shelly Ramirez, Ansoyta Said, Fernanda Tavares-Da-Silva, Jiayuan Shi, Tina Tong, John Treanor, Carlos A Diazgranados, Stephen Savarino

Publikováno v: The Lancet. Infectious Diseases

Background We evaluated our SARS-CoV-2 prefusion spike recombinant protein vaccine (CoV2 preS dTM) with different adjuvants, unadjuvanted, and in a one-injection and two-injection dosing schedule in a previous phase 1–2 study. Based on interim resu

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::af3e86897af835c9263827f1202f68fd
https://doi.org/10.1016/s1473-3099(21)00764-7

Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 Protein Vaccine

Autor: Gustavo H, Dayan, Nadine, Rouphael, Stephen R, Walsh, Aiying, Chen, Nicole, Grunenberg, Mary, Allen, Johannes, Antony, Kwaku Poku, Asante, Amit Suresh, Bhate, Tatiana, Beresnev, Matthew I, Bonaparte, Maria, Angeles Ceregido, Dmytro, Dobrianskyi, Bo, Fu, Marie-Helene, Grillet, Maryam, Keshtkar-Jahromi, Michal, Juraska, Jia Jin, Kee, Hannah, Kibuuka, Marguerite, Koutsoukos, Roger, Masotti, Nelson L, Michael, Humberto, Reynales, Merlin L, Robb, Sandra M, Villagómez Martínez, Fredrick, Sawe, Lode, Schuerman, Tina, Tong, John, Treanor, T Anh, Wartel, Carlos A, Diazgranados, Roman M, Chicz, Sanjay, Gurunathan, Stephen, Savarino, Saranya, Sridhar

Publikováno v: medRxiv : the preprint server for health sciences.

BackgroundCOVID-19 vaccines with alternative strain compositions are needed to provide broad protection against newly emergent SARS-CoV-2 variants of concern.MethodsWe conducted a global Phase 3, multi-stage efficacy study (NCT04904549) among adults

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9a3f37b0909ef7e92d9ce42be164f664
https://pubmed.ncbi.nlm.nih.gov/36523415