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

Vaccine. 2021 Jan 3;39(1):6-10. doi: 10.1016/j.vaccine.2020.10.029. Epub 2020 Dec 1.

Abstract

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.

Keywords: Adjuvanted recombinant zoster vaccine; Cross-vaccination; Herpes Zoster; Safety.

Publication types

  • Clinical Trial, Phase III
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / adverse effects
  • Adult
  • Herpes Zoster Vaccine* / adverse effects
  • Herpes Zoster* / prevention & control
  • Herpesvirus 3, Human
  • Humans
  • Middle Aged
  • Vaccines, Synthetic / adverse effects

Substances

  • Adjuvants, Immunologic
  • Herpes Zoster Vaccine
  • Vaccines, Synthetic