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

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

Josephine Ocran-Appiah  1 , Céline Boutry  2 , Caroline Hervé  3 , Jyoti Soni  4 , Anne Schuind  1 ; ZOSTER-056 Study Group
Collaborators, Affiliations
Free article
Clinical Trial

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

Josephine Ocran-Appiah et al. Vaccine. .
Free article

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.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Caroline Hervé, Josephine Ocran-Appiah, Anne Schuind, and Jyoti Soni were employees of the GSK group of companies at the time this study was designed, initiated, and/or conducted. Caroline Hervé is currently an employee of UCB Pharma. Anne Schuind holds shares in the GSK group of companies as part of her remuneration. Céline Boutry is a paid consultant at Aixial an Alten Company, serving as a Clinical Research and Development Lead on behalf of the GSK group of companies.

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