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Effect of a Zoster Vaccine on Herpes Zoster–Related Interference with Functional Status and Health‐Related Quality‐of‐Life Measures in Older Adults |
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| Authors: | Kenneth E. Schmader MD Gary R. Johnson MS Patricia Saddier PhD Maria Ciarleglio William W.B. Wang PhD Jane H. Zhang PhD Ivan S.F. Chan PhD Shing‐Shing Yeh MD Myron J. Levin MD Ruth M. Harbecke PhD Michael N. Oxman MD for the Shingles Prevention Study Group |
| Affiliation: | 1. From the*Durham Veterans Affairs Medical Center Geriatric Research, Education and Clinical Center and Duke University Medical Centers, Durham, North Carolina;2. ?Cooperative Studies Program Coordinating Center, Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut;3. ?Merck & Co., Inc., West Point, Pennsylvania;4. §Northport Veterans Affairs Medical Center and State University of New York at Stony Brook, Northport, New York;5. ∥University of Colorado Denver Health Sciences Center, Aurora, Colorado;6. and #Veterans Affairs San Diego Healthcare System and University of California, San Diego, San Diego, California. |
| 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. |
| Keywords: | herpes zoster herpes zoster vaccine aged activities of daily living |