Quality-of-Life Impact of an Investigational Subunit-Adjuvanted Herpes Zoster Vaccine in Adults ≥50 Years of Age

Abstract

Background. Herpes zoster (HZ) and its complications can have a substantial impact on patients' quality of life (QL). The ZOE 50 (NCT01165177) and ZOE 70 (NCT01165229) randomized, placebo-controlled phase-3 studies investigated the efficacy of a subunit vaccine (HZ/su), containing recombinant varicella-zoster virus glycoprotein E and the AS01B Adjuvant System, in adults aged ≥50 and ≥70 years, respectively. Here we report the impact of HZ/su on QL parameters associated with HZ episodes. Methods. Subjects received 2 doses of HZ/su or placebo intramuscularly 2 months apart. QL parameters were measured by standard instruments: The Short-Form health survey (SF-36) and Euro-Quality of Life-5 Dimension (EQ-5D) were assessed at baseline, at months 14, 26 and 38, and also during suspected HZ episodes in conjunction with the Zoster Brief Pain Inventory (ZBPI). In confirmed HZ cases, QL scores were compared between the 2 groups. The vaccine efficacy in reducing the ZBPI Burden of Illness and ZBPI Burden of Interference scores were estimated in all subjects in the modified total vaccinated cohort (mTVC). The latter 2 scores are calculated from the area under the curve (Days 0 to 182) of the ZBPI Worst pain and ZBPI Activities of Daily Living scores, respectively, assuming a score of 0 for subjects who do not have a confirmed HZ episode. These results focus on the ZOE 50 study population and the ZOE 50 and 70 pre-specified combined study populations, which include subjects, aged ≥70 years (ZOE 70+). Results. The results from the analysis of the ZBPI questionnaire are presented in the table below. HZ/su: Herpes zoster subunit vaccine; mTVC: modified total vaccinated cohort Results from the SF-36 and EQ-5D questionnaires involving repeated measurements over time will also be presented. Conclusion. In addition to significantly reducing the risk of HZ, the vaccine also reduces the severity of HZ in those who develop breakthrough disease. (Table Presented) .