Open AccessEfficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials
Author(s) -
Alemnew F. Dagnew,
Debora A. Rausch,
Caroline Hervé,
Toufik Zahaf,
Myron J. Levin,
Anne Schuind,
Zoe
Publication year - 2020
Publication title -
rheumatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.957
H-Index - 173
eISSN - 1462-0332
pISSN - 1462-0324
DOI - 10.1093/rheumatology/keaa424
Subject(s) - medicine , adverse effect , placebo , post hoc analysis , randomized controlled trial , clinical trial , pediatrics , alternative medicine , pathology
In the ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials, the adjuvanted recombinant zoster vaccine (RZV) demonstrated ≥90% efficacy in preventing herpes zoster (HZ) in all age groups ≥50 years. Given the increased HZ risk associated with certain underlying autoimmune diseases or their treatment regimes, we conducted a post hoc analysis of RZV's efficacy against HZ and safety profile [specifically, the occurrence of serious adverse events (SAEs)] in ZOE-50/70 participants who reported pre-existing potential immune-mediated diseases (pIMDs) at enrolment and were not on immunosuppressive therapies.