Safety of the adjuvanted recombinant zoster vaccine in adults aged 50 years or older. A phase IIIB, non-randomized, multinational, open-label study in previous ZOE-50 and ZOE-70 placebo recipients

Background: Efficacy of the adjuvanted recombinant zoster vaccine (RZV) against herpes zoster (HZ) was demonstrated in pivotal trials ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). This study was designed to offer RZV to placebo recipients of these parent studies. Methods: Vaccine safety and suspected HZ episode occurrence were assessed for 12 months following vaccination. Results: Of the 14,550 eligible participants, 8687 received RZV and 97.8% completed the 2-dose schedule. During the 30-day post-vaccination period, 5175 (59.6%) participants experienced >= 1 unsolicited adverse event (AE), 4422 (50.9%) were vaccination-related. The most common AEs were injection-site reactions, pyrexia, and headache. During the study, 734 (8.4%) participants reported >= 1 serious AE (SAE) and 62 (0.7%) reported >= 1 potential immune-mediated disease (pIMD); 2 of each were assessed as vaccination-related. Suspected HZ episodes were reported by 30 participants (0.3%). Conclusions: Nature and incidence of AEs, SAES, and pIMDs were as expected and in line with the parent studies. (C) 2020 GlaxoSmithKline Biologicals S.A. Published by Elsevier Ltd.

Automated summary

The efficacy of the adjuvanted recombinant zoster vaccine (RZV) against herpes zoster was confirmed in this study. The safety assessment and occurrence of adverse events, serious adverse events, and potential immune-mediated diseases were in line with the parent studies, with the incidence as expected.