Effect of a zoster vaccine on herpes zoster-related interference with functional status and health-related quality-of-life measures in older adults

Abstract

Objective: To determine the efficacy of a zoster vaccine on herpes zoster (HR)-related interference with activities of daily living (ADLs) and health-related quality of life (HRQL).

Design: Randomized double-blind placebo controlled trial.

Setting: Twenty-two U.S. sites.

Participants: Thirty eight thousand five hundred forty-six women and men aged 60 and olcer.

Measurements: HZ burden of interference with ADLs and HRQL using ratings from the Zoster Brief Pain Inventory (ZBPI) and Medical Outcomes Study 12-item Short Form Survey (SF-12) mental component summary (MCS) and physical component summary (PCS) scores. Vaccine efficacy was calculated for the modified-intention-to-treat trial population and solely in participants who developed HZ.

Results: For the modified-intention-to-treat population, the overall zoster vaccine efficacy was 66% (95% confidence interval (CI)=55-74%) for ZBPI ADL burden of interference score and 55% (95% CI=48-61%) for both the SF-12 MCS and PCS scores. Of participants who developed HZ, zoster vaccine reduced the ZBPI ADL burden of interference score by 31% (95% CI=12-51%) and did not significantly reduce the effect on HRQL.

Conclusions: Zoster vaccine reduced the burden of HZ-related interference with ADLs in the population of vaccinees and in vaccinees who developed HZ. Zoster vaccine reduced the effect of HZ on HRQL in the population of vaccinees but not in vaccinees who developed HZ.

Conflict of interest statement

Kenneth E. Schmader: Grants, including Shingles Prevention Study, consultant

Gary R. Johnson: No conflicts

Patricia Saddier: Employee

Maria Ciarleglio: No conflicts

William W.B. Wang: Employee

Jane H. Zhang: No conflicts

Ivan S.F. Chan: Employee

Shing-Shing Yeh: No conflicts, Shingles Prevention Study only

Myron J. Levin: Grants including Shingles Prevention Study, consultant, patent

Ruth M. Harbecke: No conflicts; Shingles Prevention Study only

Michael N. Oxman: No conflicts; Shingles Prevention Study only

Conflict of Interest:

This study was conducted by the Cooperative Studies Program of the Department of Veterans Affairs in collaboration with the NIAID, National Institutes of Health and Merck & Co. Inc. Funding was provided by the Cooperative Studies Program of the Department of Veterans Affairs, Office of Research and Development and by a grant from Merck & Co., Inc. to the VA Cooperative Studies Program.

© 2010, Copyright the Authors. Journal compilation © 2010, The American Geriatrics Society.

Figures

Figure 1

Zoster Vaccine Efficacy (%) in All Subjects (modified intention to treat analysis, n = 38,501). The figure shows zoster vaccine efficacy for Herpes Zoster Pain and Discomfort Burden of Illness (HZ BOI) Score (61%, 95% CI: 51, 69); Zoster Brief Pain Inventory ADL Burden of Interference Score (ZBPI BOI) (66%, 95% CI: 55, 74); SF-12 Mental Component Scale (MCS) Score (55%, 95% CI: 48, 61), and SF-12 Physical Component Scale (PCS) Score (55%, 95% CI: 48, 61).

Figure 2

Zoster Vaccine Efficacy (%) in Evaluable Cases of Herpes Zoster (n = 857). The figure shows vaccine efficacy for Herpes Zoster Pain and Discomfort Burden of Illness (HZ BOI) Score (19%, 95% CI: 2, 35); Zoster Brief Pain Inventory ADL Burden of Interference (ZBPI BOI) Score (29%, 95% CI: 7, 46), SF-12 Mental Component Scale (MCS) Score (5.2%, 95% CI: −9.4, 17.8), and SF-12 Physical Component Scale (PCS) Score (3.9%, 95% CI: −11, 16).