Martina Kovac1, Himal Lal2, Anthony L Cunningham3, Myron J Levin4, Robert W Johnson5, Laura Campora6, Antonio Volpi7, Thomas C Heineman8. 1. GSK, Rockville, MD, USA. Electronic address: martina.z.kovac@gsk.com. 2. GSK, King of Prussia, PA, USA. Electronic address: himallal@yahoo.com. 3. Westmead Institute for Medical Research, Westmead, NSW, Australia; University of Sydney, Sydney, NSW, Australia. Electronic address: tony.cunningham@sydney.edu.au. 4. Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA. Electronic address: Myron.Levin@ucdenver.edu. 5. Faculty of Health Sciences, University of Bristol, Bristol, United Kingdom. Electronic address: rwjbristol@doctors.org.uk. 6. GSK, Wavre, Belgium. Electronic address: laura.e.campora@gsk.com. 7. Università di Roma Tor Vergata, Rome, Italy. Electronic address: volpi@uniroma2.it. 8. GSK, King of Prussia, PA, USA. Electronic address: theineman@halozyme.com.
Abstract
BACKGROUND: An adjuvanted herpes zoster (HZ) subunit vaccine, HZ/su, demonstrated high efficacy against HZ and postherpetic neuralgia (PHN) in two randomized, observer-blind, placebo-controlled trials in adults aged ≥50 and ≥70 years (ZOE-50 and ZOE-70, respectively). METHODS: Data from ZOE-50 and ZOE-70 trials were analyzed to evaluate the efficacy of HZ/su against mortality, hospitalizations, and non-PHN complications of HZ including HZ-associated vasculitis, stroke, and disseminated, ophthalmic, neurologic, and visceral diseases. RESULTS: In the pooled ZOE-50/ZOE-70 analysis, 1 of 32 HZ/su recipients (3.1%) and 16 of 477 placebo recipients (3.4%) with a confirmed HZ episode had complications other than PHN. Efficacy against HZ-related complications was 93.7% (95% confidence interval, 59.5-99.9%) in adults aged ≥50 years and 91.6% (43.3-99.8%) in adults ≥70 years. Five HZ-related hospitalizations, all in placebo recipients, and no HZ-related deaths were reported. CONCLUSIONS: HZ/su reduces the risk of HZ-associated complications in older adults (NCT01165177; NCT01165229).
BACKGROUND: An adjuvanted herpes zoster (HZ) subunit vaccine, HZ/su, demonstrated high efficacy against HZ and postherpetic neuralgia (PHN) in two randomized, observer-blind, placebo-controlled trials in adults aged ≥50 and ≥70 years (ZOE-50 and ZOE-70, respectively). METHODS: Data from ZOE-50 and ZOE-70 trials were analyzed to evaluate the efficacy of HZ/su against mortality, hospitalizations, and non-PHN complications of HZ including HZ-associated vasculitis, stroke, and disseminated, ophthalmic, neurologic, and visceral diseases. RESULTS: In the pooled ZOE-50/ZOE-70 analysis, 1 of 32 HZ/su recipients (3.1%) and 16 of 477 placebo recipients (3.4%) with a confirmed HZ episode had complications other than PHN. Efficacy against HZ-related complications was 93.7% (95% confidence interval, 59.5-99.9%) in adults aged ≥50 years and 91.6% (43.3-99.8%) in adults ≥70 years. Five HZ-related hospitalizations, all in placebo recipients, and no HZ-related deaths were reported. CONCLUSIONS: HZ/su reduces the risk of HZ-associated complications in older adults (NCT01165177; NCT01165229).
Authors: Anna Mz Gagliardi; Brenda Ng Andriolo; Maria Regina Torloni; Bernardo Go Soares; Juliana de Oliveira Gomes; Regis B Andriolo; Eduardo Canteiro Cruz Journal: Cochrane Database Syst Rev Date: 2019-11-07
Authors: Harriet J Forbes; Elizabeth Williamson; Laura Benjamin; Judith Breuer; Martin M Brown; Sinéad M Langan; Caroline Minassian; Liam Smeeth; Sara L Thomas; Charlotte Warren-Gash Journal: PLoS One Date: 2018-11-21 Impact factor: 3.240