Josephine Ocran-Appiah1, Céline Boutry2, Caroline Hervé3, Jyoti Soni4, Anne Schuind1. 1. GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA. 2. Aixial an Alten Company, Chaussée de Charleroi 112, 1060 Brussels, Belgium C/O GSK, Wavre, Belgium. 3. GSK, Avenue Fleming 20, 1300 Wavre, Belgium. 4. GSK, Level 4, Prestige Trade Tower, 46, Palace Road, Sampangi Rama Nagar, Bengaluru, Karnataka 560001, India.
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.
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.
Authors: Céline Boutry; Andrew Hastie; Javier Diez-Domingo; Juan Carlos Tinoco; Chong-Jen Yu; Charles Andrews; Jean Beytout; Covadonga Caso; Huey-Shinn Cheng; Hee Jin Cheong; Eun Ju Choo; Dan Curiac; Emmanuel Di Paolo; Marc Dionne; Tamara Eckermann; Meral Esen; Murdo Ferguson; Wayne Ghesquiere; Shinn-Jang Hwang; Thiago Junqueira Avelino-Silva; Pavel Kosina; Chiu-Shong Liu; Jukka Markkula; Beate Moeckesch; Cláudia Murta de Oliveira; Dae Won Park; Karlis Pauksens; Paola Pirrotta; Georg Plassmann; Carol Pretswell; Lars Rombo; Bruno Salaun; Johan Sanmartin Berglund; Isabelle Schenkenberger; Tino Schwarz; Meng Shi; Benita Ukkonen; Toufik Zahaf; Cristiano Zerbini; Anne Schuind; Anthony L Cunningham Journal: Clin Infect Dis Date: 2022-04-28 Impact factor: 20.999