Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials |
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| Authors: | Marta López-Fauqued Laura Campora Frédérique Delannois Mohamed El Idrissi Lidia Oostvogels Ferdinandus J. De Looze Javier Diez-Domingo Thomas C. Heineman Himal Lal Janet E. McElhaney Shelly A. McNeil Wilfred Yeo Fernanda Tavares-Da-Silva |
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| Affiliation: | 9. University of Tampere, Järvenpää Vaccine Clinic, Finland;10. University of São Paulo Medical School, Brazil;11. Instituto Dermatológico de Jalisco, Mexico;12. Blekinge Institute of Technology, Sweden;13. EAP Sardenya, Spain;14. Hospital Clínico San Carlos, Spain;15. University of Defence, Faculty of Military Health Sciences, Czech Republic;p. Korea University College of Medicine, Republic of Korea;q. Westmead Institute for Medical Research, University of Sydney, Australia;r. Servizio di Igiene Pubblica, Italy;s. Doctors of Ivanhoe, Australia;t. Institut für Tropenmedizin, University Clinic of Tübingen, Germany;u. GSK, Belgium;v. Q&T Research Sherbrooke, Canada;w. University of British Columbia, Canada;x. GSK, Belgium, during the conduct of the ZOE-50/70 trials, Belgium;y. York University, Canada;z. Prince of Wales Hospital, Hong Kong;11. Taipei Veterans General Hospital and National Yang Ming University School of Medicine, Taiwan;12. Vaccine Research Centre, University of Tampere Medical School, Tampere, Finland;13. GSK, USA;14. GSK, Belgium;15. Hong Kong Association of Gerontology, Hong Kong;16. University of Colorado Anschutz Medical Campus, USA;17. CAP Centelles, Spain;18. Instituto A. Z. de Pesquisa e Ensino, Brazil;19. Uppsala University Hospital, Sweden;110. Kliiniliste Uuringute Keskus, Estonia;111. Hospital Puerta de Hierro, Spain;112. Uppsala University, Sweden;113. Standort Juliusspital, Germany;114. University of Defence, Faculty of Military Health Sciences, Czech Republic;115. University G. d''Annunzio of Chieti-Pescara, Italy;1p. Hospital General de Durango, Mexico;1q. Manna Research, Canada;1r. GSK, Belgium;1s. University of Tampere, Finland;1t. A.O. Univesitaria Policlinico Tor Vergata, Italy;1u. Kobe University Graduate School of Medicine, Japan;1v. Federal University of Sao Paulo, Brazil;1w. GSK, Belgium;1. GSK, Wavre, Belgium;2. GSK, Rixensart, Belgium;3. AusTrials Pty Ltd, Sherwood and School of Medicine, University of Queensland, Brisbane, Queensland, Australia;4. Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain;5. GSK, King of Prussia, PA, USA;6. Health Sciences North Research Institute, Sudbury, Ontario, Canada;7. Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, Nova Scotia, Canada;8. School of Medicine, University of Wollongong, Wollongong, Australia |
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| Abstract: | ![]()
BackgroundThe 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.MethodsAdults 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.ResultsSafety 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.ConclusionsNo safety concerns arose, supporting the favorable benefit-risk profile of RZV. |
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| Keywords: | Varicella-zoster virus Vaccine Safety Reactogenicity HZ herpes zoster RZV adjuvanted recombinant zoster vaccine VZV varicella-zoster virus gE VZV glycoprotein E AE adverse event SAE serious AE pIMD potential immune-mediated disease D day M month Y year YOA years of age ZOE-50/70 the pivotal RZV efficacy trials in adults ≥50/≥70 YOA MedDRA medical dictionary for regulatory activities SOC system organ class PT preferred term CI confidence interval RR relative risk AML acute myeloid leukemia |
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