Dataset Information

Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older.

ABSTRACT: BACKGROUND:To determine the efficacy of an adjuvanted recombinant zoster vaccine in reducing the herpes zoster (HZ) burden of illness, HZ burden of interference with activities of daily living, and HZ impact on quality of life. METHODS: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 activities of daily living were assessed by the Zoster Brief Pain Inventory (ZBPI) instrument and quality of life 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 patients aged 70 years and older from the trials combined. RESULTS:The estimated vaccine efficacy in reducing HZ burden of illness and HZ burden of interference was greater than 90% in both the ZOE-50 and the pooled ZOE-70 analysis. In confirmed HZ cases, adjuvanted recombinant zoster vaccine reduced the maximal ZBPI worst-pain score in the pooled ZOE-70 analysis (p = .032) and the maximal ZBPI average-pain scores in both the ZOE-50 (p = .049) and the pooled ZOE-70 analysis (p = .043). In breakthrough HZ cases, trends for diminished loss of quality of life compared with placebo-recipient HZ cases were observed, with differences up to 0.14 on the EQ-5D index at time points during the 4 weeks following HZ onset. CONCLUSIONS:Adjuvanted recombinant zoster vaccine reduced the HZ burden of illness significantly, particularly due to its very high vaccine efficacy in preventing HZ. For breakthrough HZ cases, the results suggest that the adjuvanted recombinant zoster vaccine mitigated severity of HZ-related pain, burden of interference with activities of daily living, and recipients' utility loss.

SUBMITTER: Curran D

PROVIDER: S-EPMC6625590 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older.

Curran Desmond D Oostvogels Lidia L Heineman Thomas T Matthews Sean S McElhaney Janet J McNeil Shelly S Diez-Domingo Javier J Lal Himal H Andrews Charles C Athan Eugene E Berglund Johan J Campora Laura L de Looze Ferdinandus F Korhonen Tiina T Leung Edward E Levin Myron M Volpi Antonio A Johnson Robert W RW

The journals of gerontology. Series A, Biological sciences and medical sciences 20190701 8

<h4>Background</h4>To determine the efficacy of an adjuvanted recombinant zoster vaccine in reducing the herpes zoster (HZ) burden of illness, HZ burden of interference with activities of daily living, and HZ impact on quality of life.<h4>Methods</h4>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 activities of daily living were assessed by the Zoster Brief Pain Inventory (ZBPI) instru ...[more]

PMID: 29955836

Similar Datasets

Project description:Abstract Background The recombinant herpes zoster (HZ) subunit vaccine (HZ/su) has shown efficacy against HZ in adults ?50 and ?70 years of age (YOA), in two pivotal Phase III clinical trials (NCT01165177, NCT01165229). A pooled safety analysis of data from these two efficacy studies was performed, including a comparative analysis on HZ/su vs. placebo groups, to provide a comprehensive understanding of the HZ/su safety profile. Methods Two pivotal, randomized, placebo-controlled Phase III studies, assessed the efficacy, reactogenicity and safety of HZ/su, administered intramuscularly according to a 0, 2-month schedule. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each dose, respectively; serious AEs (SAEs) for 1 year after last dose; fatal and related SAEs and potential immune-mediated diseases (pIMDs) during the entire study period. Reactogenicity was assessed in a subset of participants; safety was assessed in all vaccinated participants. Results 29,305 participants ?50 YOA (HZ/su: 14,645; placebo: 14,660) were included in the pooled analysis. HZ/su was more reactogenic than placebo. Local reactions were mostly mild to moderate in intensity and transient (median duration = 3 days); the percentages of participants reporting SAEs, fatal SAEs and pIMDs were similar in both groups, at 30 days and 1 year after last dose (Figures 1 and 2). Percentages of fatal SAEs ranged between 4.3% (95% Confidence Interval [CI]: 4.0–4.7) and 4.6% (95% CI: 4.3–5.0) and pIMDs between 1.2% (95% CI: 1.1–1.4) and 1.4% (95% CI: 1.2–1.6), in HZ/su and placebo groups, respectively. In both groups, the most frequent causes of death were neoplasms, cardiac disorders, and respiratory tract infections and infestations, and most frequent pIMDs were polymyalgia rheumatica, rheumatoid arthritis and psoriasis. Conclusion No safety concern was identified. Together with the high efficacy against HZ (97.2% [95% CI: 93.7–99.0],1 91.3% [95% CI: 86.8–94.5]2), the safety data supports a favorable benefit/risk profile of HZ/su in participants ?50 YOA. Funding GlaxoSmithKline Biologicals SA Disclosures M. López-Fauqued, GSK Biologicals’: Employee, Salary; ?L. Campora, GSK Biologicals’: Employee, Salary; F. Delannois, GSK Vaccines: Employee, Salary; M. El Idrissi, GSK Vaccines: Employee, Salary; E. Ledent, GSK Vaccines: Employee, Salary; J. Diez-Domingo, GSK Vaccines: Consultant and Investigator, Educational support and Research grant; J. McElhaney, GSK Vaccines: Scientific Advisor, Speaker honorarium; S. McNeil, GSK/Merck: Grant Investigator, Investigator and Scientific Advisor, Consulting fee, Grant recipient, Research grant, Research support and Speaker honorarium; F. De Looze, GSK Vaccines: Investigator and Research Contractor, Research support; F. Tavares Da Silva, GSK Vaccines: Employee, restricted shares and Salary

Project description:INTRODUCTION:The incidence of herpes zoster (HZ) rises steeply after the age of 50 years and the number of HZ cases and complications such as postherpetic neuralgia (PHN) is predicted to increase because of the ageing population. The objective of this study was to estimate the cost-effectiveness of recombinant zoster vaccine (RZV) compared with no vaccine for the Japanese population aged ≥ 65 years. METHODS:A multi-cohort static Markov model with a cycle length of 1 year was used to follow a hypothetical cohort of 1 million people aged ≥ 65 years over their remaining lifetime. Vaccination at ≥ 65 years was used in alignment with the influenza and pneumococcal vaccines recommended from 65 years. Japan-specific data inputs for the model were obtained from local data sources. Age-stratified vaccine efficacy and waning rates were based on published clinical trial data. In the base-case analysis, vaccine coverage was assumed to be 40% with a second dose compliance of 95%. Costs and outcomes were discounted at 2% annually and the incremental cost-effectiveness ratio (ICER) was calculated from both a payer's and the societal perspective. Sensitivity analyses were carried out to explore the overall uncertainty in the model. RESULTS:Vaccination with RZV was projected to prevent 48,943 HZ cases and 12,136 PHN cases per million people aged ≥ 65 years compared with no vaccination. The incremental costs and quality-adjusted life years (QALYs) gained were ¥9.99 billion and 2314 QALYs from a payer's perspective and ¥9.34 billion and 2314 QALYs from a societal perspective. The resulting ICERs were approximately ¥4,320,000 and ¥4,040,000 per QALY gained from a payer's and the societal perspective, respectively. The ICER remained below a willingness-to-pay threshold of ¥5,000,000 for most sensitivity analyses carried out. CONCLUSION:Vaccination against HZ with RZV would be cost-effective compared with no vaccination for the Japanese population aged ≥ 65 years. TRIAL REGISTRATION:GSK study identifier: HO-16-17837. FUNDING:GlaxoSmithKline Biologicals SA.

Dataset Information

Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older.

Publications

Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets