Safety profile of the adjuvanted recombinant zoster vaccine : Pooled analysis of two large randomised phase 3 trials
López Fauqued, Marta (GlaxoSmithKline (GSK))
Campora, Laura (GlaxoSmithKline (GSK))
Delannois, Frédérique (GlaxoSmithKline (GSK))
El Idrissi, Mohamed (GlaxoSmithKline (GSK))
Oostvogels, Lidia (GlaxoSmithKline (GSK))
De Looze, Ferdinandus (University of Queensland)
Diez-Domingo, Javier (Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (València))
Heineman, Thomas (GlaxoSmithKline (GSK))
Lal, Himal (GlaxoSmithKline (GSK))
McElhaney, Janet (Health Sciences North Research Institute)
McNeil, Shelly (Dalhousie University)
Yeo, Wilfred (University of Wollongong)
Tavares-Da-Silva, Fernanda (GlaxoSmithKline (GSK))
Ahonen, Anitta (University of Tampere)
Avelino-Silva, Thiago (University of São Paulo Medical School)
Barba-Gomez, José Fernando (Instituto Dermatológico de Jalisco)
Berglund, Johan (Blekinge Institute of Technology)
Brotons, Carlos (Institut d'Investigació Biomèdica Sant Pau)
Caso, Covadonga (Hospital Clínico San Carlos (Madrid))
Chlibek, Roman (University of Defence)
Choi, Won Suk (Korea University College of Medicine)
Cunningham, Anthony (University of Sydney)
Desole, Maria Giuseppina (Servizio di Igiene Pubblica)
Eizenberg, Peter (Doctors of Ivanhoe)
Esen, Meral (University Clinic of Tübingen)
Espié, Emmanuelle (GlaxoSmithKline (GSK))
Gervais, Pierre (Q&T Research Sherbrooke)
Ghesquiere, Wayne (University of British Columbia)
Godeaux, Olivier O. (GlaxoSmithKline (GSK))
Gorfinkel, Iris (York University)
Hui, David Shu Cheong (Prince of Wales Hospital (Australia))
Hwang, Shinnjang (Taipei Veterans General Hospital and National Yang Ming University School of Medicine)
Korhonen, Tiina (University of Tampere Medical School)
Kovac, Martina (GlaxoSmithKline (GSK))
Ledent, Edouard Y. (GlaxoSmithKline (GSK))
Leung, Edward Man Fuk (Hong Kong Association of Gerontology)
Levin, Myron (University of Colorado Anschutz Medical Campus)
Perez, Silvia Narejos (CAP Centelles)
de Andrade Neto, José Luiz (Instituto A. Z. de Pesquisa e Ensino)
Pauksens, Karlis (Uppsala University Hospital)
Poder, Airi (Kliiniliste Uuringute Keskus)
Rodriguez de la Pinta, Maria Luisa (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Rombo, Lars (Uppsala University)
Schwarz, Tino Francis (Standort Juliusspital)
Smetana, Jan (University of Defence)
Staniscia, Tommaso (University G. d'Annunzio of Chieti-Pescara)
Tinoco-Fávila, Juan Carlos (Hospital General de Durango)
Toma, Azhar (Manna Research)
Vastiau, Ilse (GlaxoSmithKline (GSK))
Vesikari, Timo H. (University of Tampere)
Volpi, Antonio (A.O. Univesitaria Policlinico Tor Vergata)
Watanabe, Daisuke (Kobe University Graduate School of Medicine)
Weckx, Lily (Federal University of Sao Paulo)
Zahaf, Toufik (GlaxoSmithKline (GSK))
Universitat Autònoma de Barcelona

Date:	2019
Abstract:	The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50. 5% versus 32. 0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10. 1%; Placebo: 10. 4%), fatal AEs (RZV: 4. 3%; Placebo: 4. 6%), and pIMDs (RZV: 1. 2%; Placebo: 1. 4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. No safety concerns arose, supporting the favorable benefit-risk profile of RZV.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Reactogenicity ; Safety ; Vaccine ; Varicella-zoster virus
Published in:	Vaccine, Vol. 37 Núm. 18 (24 2019) , p. 2482-2493, ISSN 1873-2518

DOI: 10.1016/j.vaccine.2019.03.043
PMID: 30935742

12 p, 484.6 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
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