Quality of life impact of an adjuvanted recombinant zoster vaccine in adults aged 50 years and older

To determine the efficacy of a recombinant zoster vaccine (RZV) in reducing the herpes zoster (HZ) burden of illness, HZ burden of interference with activities of daily living (ADLs) and HZ impact on quality of life (QoL). The assessments were integrated in two Phase III trials, ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). HZ burden of illness and HZ burden of interference with ADLs were assessed by the Zoster Brief Pain Inventory (ZBPI) instrument; QoL by the EuroQol-5 Dimension (EQ-5D) utility index and the SF-36 health survey. We report the ZOE-50 results and a pooled analysis of subjects ≥70 years of age from the trials combined. The estimated vaccine efficacy (VE) in reducing HZ burden of illness as well as HZ burden of interference was >90% in both the ZOE-50 and the pooled ZOE-70 analysis. In confirmed HZ cases, RZV reduced the maximal ZBPI worst-pain score in the pooled ZOE-70 analysis (p=0.032) and the maximal ZBPI average-pain scores in both the ZOE-50 (p=0.049) and the pooled ZOE-70 analysis (p=0.043). In breakthrough HZ cases, trends for diminished loss of QoL compared to placebo-recipient HZ cases were observed, with differences up to 0.14 on the EQ-5D index at time points during the four weeks following HZ onset. RZV reduced the HZ burden of illness significantly, particularly due to its very high VE in preventing HZ. For breakthrough HZ cases, the results suggest that RZV mitigated severity of HZ-related pain, burden of interference with ADLs and recipients' utility loss.