Michael N Oxman1, Myron J Levin. 1. VA San Diego Healthcare System, San Diego, California, USA. mnoxman@ucsd.edu
Abstract
BACKGROUND:Herpes zoster (HZ) and postherpetic neuralgia (PHN) cause significant morbidity in older adults. The incidence and severity of HZ and PHN increase with age in association with an age-related decline in varicella-zoster virus (VZV)-specific cell-mediated immunity (VZV-CMI). VZV vaccines can boost VZV-CMI. Therefore, we tested the hypothesis that VZV vaccination would protect older adults against HZ and PHN. METHODS:We enrolled 38,546 adults > or =60 years of age in a randomized, double-blind, placebo-controlled trial of an investigational HZ vaccine and actively followed subjects for the development of HZ. The primary end point was the burden of illness due to HZ (HZ BOI), a composite measure of the incidence, severity, and duration of pain and discomfort caused by HZ. The secondary end point was the incidence of PHN. RESULTS: Subject retention was >95%. HZ vaccine reduced the HZ BOI by 61.1% (95% confidence interval [CI], 51.1%-69.1%; P<.001) and reduced the incidence of PHN by 66.5% (95% CI, 47.5%-79.2%; P<.001). The incidence of HZ was also reduced by 51.3% (95% CI, 44.2%-57.6%; P<.001). HZ vaccine was well tolerated; injection site reactions were generally mild. HZ vaccine neither caused nor induced HZ. CONCLUSION: The Shingles Prevention Study demonstrated that HZ vaccine significantly reduced the morbidity due to HZ and PHN in older adults.
RCT Entities:
BACKGROUND: Herpes zoster (HZ) and postherpetic neuralgia (PHN) cause significant morbidity in older adults. The incidence and severity of HZ and PHN increase with age in association with an age-related decline in varicella-zoster virus (VZV)-specific cell-mediated immunity (VZV-CMI). VZV vaccines can boost VZV-CMI. Therefore, we tested the hypothesis that VZV vaccination would protect older adults against HZ and PHN. METHODS: We enrolled 38,546 adults > or =60 years of age in a randomized, double-blind, placebo-controlled trial of an investigational HZ vaccine and actively followed subjects for the development of HZ. The primary end point was the burden of illness due to HZ (HZ BOI), a composite measure of the incidence, severity, and duration of pain and discomfort caused by HZ. The secondary end point was the incidence of PHN. RESULTS: Subject retention was >95%. HZ vaccine reduced the HZ BOI by 61.1% (95% confidence interval [CI], 51.1%-69.1%; P<.001) and reduced the incidence of PHN by 66.5% (95% CI, 47.5%-79.2%; P<.001). The incidence of HZ was also reduced by 51.3% (95% CI, 44.2%-57.6%; P<.001). HZ vaccine was well tolerated; injection site reactions were generally mild. HZ vaccine neither caused nor induced HZ. CONCLUSION: The Shingles Prevention Study demonstrated that HZ vaccine significantly reduced the morbidity due to HZ and PHN in older adults.
Authors: Vicki A Morrison; Gary R Johnson; Kenneth E Schmader; Myron J Levin; Jane H Zhang; David J Looney; Robert Betts; Larry Gelb; John C Guatelli; Ruth Harbecke; Connie Pachucki; Susan Keay; Barbara Menzies; Marie R Griffin; Carol A Kauffman; Adriana Marques; John Toney; Kathy Boardman; Shu-Chih Su; Xiaoming Li; Ivan S F Chan; Janie Parrino; Paula Annunziato; Michael N Oxman Journal: Clin Infect Dis Date: 2014-11-20 Impact factor: 9.079
Authors: K E Schmader; M N Oxman; M J Levin; G Johnson; J H Zhang; R Betts; V A Morrison; L Gelb; J C Guatelli; R Harbecke; C Pachucki; S Keay; B Menzies; M R Griffin; C Kauffman; A Marques; J Toney; P M Keller; X Li; I S F Chan; P Annunziato Journal: Clin Infect Dis Date: 2012-07-24 Impact factor: 9.079
Authors: Bong-Seong Kim; Sonia Mehra; Barbara Yawn; Charles Grose; Robert Tarrell; Brian Lahr; Young J Juhn Journal: J Pediatr Date: 2013-04-13 Impact factor: 4.406