Safety and Humoral Immunogenicity of Different Dose Levels of Ad26.COV2.S as a 2-Dose Regimen in COVID-19 Vaccine-Naïve Healthy Adults: A Phase 3 Randomized Clinical Trial

Autor: Veronica V. Rezelj, Fred Paddenburg, Marie Enajite Diegbe, Julius Nangosyah, Emil C. Reisinger, Weihong Hu, Carla Truyers, Gert Scheper, Mathieu Le Gars, Jenny Hendriks, Frank Struyf, Macaya Douoguih, Hanneke Schuitemaker, Javier Ruiz-Guiñazú

Publikováno v: Vaccines, Vol 12, Iss 10, p 1136 (2024)

Background: This study aimed to support the end-of-shelf life specification (2.5 × 1010 virus particles [vp]) for the standard Ad26.COV2.S dose (5 × 1010 vp). Methods: This randomized, double-blind Phase 3 study evaluated immunogenicity, reactogeni

Externí odkaz: https://doaj.org/article/54705ff51339487aa084bce5e1e25b60

Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2): results of a randomised, double-blind, placebo-controlled, phase 3 trial

Autor: Karin Hardt, An Vandebosch, Jerald Sadoff, Mathieu Le Gars, Carla Truyers, David Lowson, Ilse Van Dromme, Johan Vingerhoets, Tobias Kamphuis, Gert Scheper, Javier Ruiz-Guiñazú, Saul N Faust, Christoph D Spinner, Hanneke Schuitemaker, Johan Van Hoof, Macaya Douoguih, Frank Struyf, Brian T. Garibaldi, Timothy E. Albertson, Christian Sandrock, Janet S. Lee, Mark R. Looney, Victor F. Tapson, Charles Shey Wiysonge, Luis Humberto Anaya Velarde, Daniel Backenroth, Jisha Bhushanan, Börries Brandenburg, Vicky Cárdenas, Bohang Chen, Fei Chen, Polan Chetty, Pei-Ling Chu, Kimberly Cooper, Jerome Custers, Hilde Delanghe, Anna Duca, Tracy Henrick, Jarek Juraszek, Catherine Nalpas, Monika Peeters, Jose Pinheiro, Sanne Roels, Martin F. Ryser, Jose Salas, Samantha Santoro Matias, Ilse Scheys, Pallavi Shetty, Georgi Shukarev, Jeffrey Stoddard, Willem Talloen, NamPhuong Tran, Nathalie Vaissiere, Elisabeth van Son-Palmen, Jiajun Xu, Erin A. Goecker, Alexander L. Greninger, Keith R. Jerome, Pavitra Roychoudhury, Simbarashe G. Takuva, Jose Luis Accini Mendoza, Eric Achtyes, Habibul Ahsan, Azhar Alhatemi, Nancy Allen, Jose R. Arribas, Ghazaleh Bahrami, Lucia Bailon, Ali Bajwa, Jonathan Baker, Mira Baron, Susana Benet, Driss Berdaï, Patrick Berger, Todd Bertoch, Claire Bethune, Sybille Bevilacqua, Maria Silvia Biagioni Santos, Ian Binnian, Karen Bisnauthsing, Jean-Marc Boivin, Hilde Bollen, Sandrine Bonnet, Alberto M. Borobia, Elisabeth Botelho-Nevers, Phil Bright, Vianne Britten, Claire Brown, Amanda Buadi, Erik Buntinx, Lesley Burgess, Larry Bush, Maria Rosario Capeding, Quito Osuna Carr, Amparo Carrasco Mas, Hélène Catala, Katrina Cathie, T. Shawn Caudill, Fernando Cereto Castro, Kénora Chau, Steven Chavoustie, Marie Chowdhury, Nicolas Chronos, Paola Cicconi, Liliana Cifuentes, Sara Maria Cobo, Helen Collins, Hayley Colton, Carlos Rolando G. Cuaño, Valentino D'Onofrio, Paul Dargan, Thomas Darton, Peter Deane, Jose Luis Del Pozo, Inge Derdelinckx, Amisha Desai, Michael Dever, Beatriz Díaz-Pollán, Mark DiBuono, Matthew Doust, Christopher Duncan, Jose Maria Echave-Sustaeta, Frank Eder, Kimberly Ellis, Stanton Elzi, Stevan Emmett, Johannes Engelbrecht, Mim Evans, Theo Farah, Timothy Felton, João Pedro Ferreira, Catherine Floutier, Patrick Flume, Stacy Ford, Veronica Fragoso, Andrew Freedman, Emilia Frentiu, Christopher Galloway, Florence Galtier, Julia Garcia Diaz, Irene García García, Alcaide Garcia, Zoe Gardener, Pascale Gauteul, Steven Geller, Andrew Gibson, Claudia Gillet, Nicolas Girerd, Pierre-Olivier Girodet, Maria Tarcela Gler, Richard Glover, Herschel Don D. Go, Karishma Gokani, Damien Gonthier, Christopher Green, Richard Greenberg, Carl Griffin, Coert Grobbelaar, Adonis Guancia, Gloria Hakkarainen, James Harris, Michael Hassman, Deirdre Heimer, Elizabeth Hellstrom-Louw, Yoan Herades, Christopher Holroyd, Nazreen Hussen, Marie Grace Dawn Isidro, Yvonne Jackson, Manish Jain, Esaú Custódio João Filho, Daniel Johnson, Ben Jones, Natasha Joseph, Analyn Jumeras, Patricia Junquera, Johanna Kellett-Wright, Patrick Kennedy, Paul E. Kilgore, Kenneth Kim, Murray Kimmel, George Konis, Mark Kutner, Karine Lacombe, Odile Launay, Rajeka Lazarus, Samuel Lederman, Gigi Lefebvre, Katrina Lennon Collins, Isabel Leroux-Roels, Kenneth Wilson O. Lim, Muriel Lins, Edward Liu, Martin Llewelyn, Akbar Mahomed, Bernardo Porto Maia, Alícia Marín-Candon, Xavier Martínez-Gómez, Jean Benoit Martinot, Andrea Mazzella, Frank McCaughan, Louise McCormack, John McGettigan, Purvi Mehra, Rhonda Mejeur, Vicki Miller, Anthony Mills, Jose Molto Marhuenda, Prebashan Moodley, Marta Mora-Rillo, Beatriz Mothe, Daniel Mullan, Alasdair Munro, Paul Myers, Jeremy Nell, Tamara Newman Lobato Souza, Jane A. O'Halloran, Maria Dolores Ochoa Mazarro, Abigail Oliver, Jose Millan Onate Gutierrez, Jessica Ortega, Masaru Oshita, Susana Otero Romero, Jeffrey Scott Overcash, Daniel Owens, Alice Packham, Mihaela Pacurar, Leonardo Paiva de Sousa, Adrian Palfreeman, Christian José Pallares, Rahul Patel, Suchet Patel, Leslie Pelkey, Denise Peluso, Florentina Penciu, S. Jerry Pinto, Kevin Pounds, Joe Pouzar, Antoinette Pragalos, Rachel Presti, David Price, Ehsaan Qureshi, José Valdez Ramalho Madruga, Mayur Ramesh, Bruce Rankin, Béatrice Razat, Breno Riegel Santos, Robert Riesenberg, Ernie Riffer, Siobhan Roche, Katie Rose, Pietro Rosellini, Patrick Rossignol, Beth Safirstein, Hernan Salazar, Gregorio Sanchez Vallejo, Smrithi Santhosh, Enrique Seco-Meseguer, Michael Seep, Emma Sherry, Philip Short, Patrick Soentjens, Joel Solis, Alejandro Soriano Viladomiu, Caroline Sorli, Selwyn Spangenthal, Niamh Spence, Elaine Stephenson, Cynthia Strout, Ronald Surowitz, Kristy Michelle Taladua, David Tellalian, Claire Thalamas, Nang Thiriphoo, Judith Thomas, Nicholas Thomas, Guillermo Trout, Mikel Urroz, Bernard Veekmans, Laurent Veekmans, Ralph Elvi M. Villalobos, Sarah Warren, Brian Webster, Alexander White, Gail Williams, Hayes Williams, Barbara Wilson, Alan Winston, Martin Wiselka, Marcus Zervos

Publikováno v: The Lancet Infectious Diseases. 22:1703-1715

Despite the availability of effective vaccines against COVID-19, booster vaccinations are needed to maintain vaccine-induced protection against variant strains and breakthrough infections. This study aimed to investigate the efficacy, safety, and imm

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::07f798572b21f13734646bce589e2214
https://doi.org/10.1016/s1473-3099(22)00506-0

Oral HPV16 DNA as a screening tool to detect early oropharyngeal squamous cell carcinoma

Autor: Kai Dun Tang, Touraj Taheri, Brett G.M. Hughes, Chamindie Punyadeera, Liz Kenny, Gert Scheper, Sarju Vasani, Laurence J. Walsh, Lilian Menezes, Ian H. Frazer

Publikováno v: Cancer Science

Given that oropharyngeal squamous cell carcinoma (OPSCC) have now surpassed cervical cancer as the most common human papillomavirus (HPV)‐driven cancer, there is an interest in developing non‐invasive predictive biomarkers to early detect HPV‐d

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1f149cb3da6721b619faa40b367029c5
https://doi.org/10.1111/cas.14585

Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials

Autor: Jerald Sadoff, Mathieu Le Gars, Boerries Brandenburg, Vicky Cárdenas, Georgi Shukarev, Nathalie Vaissiere, Dirk Heerwegh, Carla Truyers, Anne Marit de Groot, Mandy Jongeneelen, Krisztian Kaszas, Jeroen Tolboom, Gert Scheper, Jenny Hendriks, Javier Ruiz-Guiñazú, Frank Struyf, Johan Van Hoof, Macaya Douoguih, Hanneke Schuitemaker

Publikováno v: Vaccine. 40(32)

Ad26.COV2.S is a well-tolerated and effective vaccine against COVID-19. We evaluated durability of anti-SARS-CoV-2 antibodies elicited by single-dose Ad26.COV2.S and the impact of boosting.In randomized, double-blind, placebo-controlled, phase 1/2a a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0c62279831d027400025f654a09dbe93
https://pubmed.ncbi.nlm.nih.gov/35667914

RCT Abstract - Ad26.COV2.S immunogenicity in a Phase 2 trial at different booster dose levels and schedule intervals in adults

Autor: Gert Scheper, Macaya Douoguih, Frank Struyf, Mathieu Le Gars, Vicky Cárdenas, Hanneke Schuitemaker, Jenny Hendriks, Javier Ruiz Guiñazú, Nathalie Vaissiere, Carla Truyers, Jerald C. Sadoff

Publikováno v: Respiratory infections and bronchiectasis.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::5323a1054539d03632c8bed5c4236720
https://doi.org/10.1183/13993003.congress-2021.pa489