Harmonizing the collection of solicited adverse events in prophylactic vaccine clinical trials

Autor: Brigitte Cheuvart, Bart Spiessens, Roy van Heesbeen, Derchieh Hung, Coralie Andrade, Joanna Korejwo-Peyramond, Fernanda Tavares-Da-Silva

Publikováno v: Expert Review of Vaccines, Vol 22, Iss 1, Pp 849-859 (2023)

Introduction During the clinical development of a vaccine, study participants are monitored for the occurrence of adverse events (AEs) over a defined period post-vaccination to assess the safety of prophylactic vaccines. Among the safety data collect

Externí odkaz: https://doaj.org/article/cbc911602f9340d994b7605dc8bd9913

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

Fourteen years of the Pregnancy Registry on maternal immunisation with a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine

Autor: Anastasia, Kuznetsova, Maria Angeles, Ceregido, Anne, Jourquin, Laura, Campora, Fernanda Tavares, Da Silva

Publikováno v: Vaccine. 40:904-911

GSK initiated a Pregnancy Registry in the United States (US) for the reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap; Boostrix, GSK) vaccine with the aim to detect and describe pregnancy outcomes in women vaccinated with Boostrix

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ad7f56d5777d0c8937793997855285a4
https://doi.org/10.1016/j.vaccine.2021.12.050

An Analysis of Spontaneously Reported Data of Vesicular and Bullous Cutaneous Eruptions Occurring Following Vaccination with the Adjuvanted Recombinant Zoster Vaccine

Autor: Jens-Ulrich Stegmann, Fernanda Tavares-Da-Silva, Paola Pirrotta, Nicolas Lecrenier, Caroline Hervé, Maribel Miranda Co

Publikováno v: Drug Safety

Introduction With the approval of the adjuvanted recombinant zoster vaccine (RZV; Shingrix, GSK) in October 2017, GSK established enhanced safety surveillance measures to allow prompt identification of potential safety signals not observed during cli

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7015f764ca2baaf6080e3a137f332753
http://europepmc.org/articles/PMC8626369