Zoster Vaccine and Herpes Zoster-Related Interference With Functional Status
Zoster Vaccine and Herpes Zoster-Related Interference With Functional Status
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.
Herpes zoster (HZ) increases in frequency and severity with advancing age. The negative effect of HZ on activities of daily living (ADLs) in older adults is due primarily to the effects of HZ-related acute and chronic pain and discomfort, although the effects of the rash, of eye involvement, and of neurological complications are also important. Acute and chronic HZ pain and discomfort reduce physical, emotional, and social functioning; lower vitality; impair physical and mental health; and interfere with ADLs in older adults. The magnitude of HZ-related interference with ADLs increases with increasing pain severity. Furthermore, the negative effect of HZ on ADLs and quality of life may occur in older individuals who are already experiencing disability from other common age-related diseases or conditions.
In Veterans Affairs (VA) Cooperative Study 403: The Shingles Prevention Study, zoster vaccine significantly reduced the incidence of HZ, the incidence of postherpetic neuralgia, and the burden of illness due to HZ pain and discomfort. Recognizing the adverse effect of HZ on ADLs and the importance of these outcomes in older adults, the Shingles Prevention Study included preplanned analyses of the effect of zoster vaccine on HZ-related interference with functional status and on generic measures of health-related quality of life (HRQL). This article describes the results of these analyses on ADLs and HRQL in all individuals who received vaccine or placebo and in recipients of vaccine or placebo who developed HZ. An additional objective of this article is to describe the effects of increasing age on these measures of zoster vaccine efficacy.
Abstract and Introduction
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.
Introduction
Herpes zoster (HZ) increases in frequency and severity with advancing age. The negative effect of HZ on activities of daily living (ADLs) in older adults is due primarily to the effects of HZ-related acute and chronic pain and discomfort, although the effects of the rash, of eye involvement, and of neurological complications are also important. Acute and chronic HZ pain and discomfort reduce physical, emotional, and social functioning; lower vitality; impair physical and mental health; and interfere with ADLs in older adults. The magnitude of HZ-related interference with ADLs increases with increasing pain severity. Furthermore, the negative effect of HZ on ADLs and quality of life may occur in older individuals who are already experiencing disability from other common age-related diseases or conditions.
In Veterans Affairs (VA) Cooperative Study 403: The Shingles Prevention Study, zoster vaccine significantly reduced the incidence of HZ, the incidence of postherpetic neuralgia, and the burden of illness due to HZ pain and discomfort. Recognizing the adverse effect of HZ on ADLs and the importance of these outcomes in older adults, the Shingles Prevention Study included preplanned analyses of the effect of zoster vaccine on HZ-related interference with functional status and on generic measures of health-related quality of life (HRQL). This article describes the results of these analyses on ADLs and HRQL in all individuals who received vaccine or placebo and in recipients of vaccine or placebo who developed HZ. An additional objective of this article is to describe the effects of increasing age on these measures of zoster vaccine efficacy.
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