title: Efficacy, safety, and tolerability of herpes zoster vaccine in persons aged 50-59 years.
abstract: BACKGROUND
  Herpes zoster (HZ) adversely affects individuals aged 50-59, but vaccine efficacy has not been assessed in this population. This study was designed to determine the efficacy, safety, and tolerability of zoster vaccine for preventing HZ in persons aged 50-59 years.
  
  
  METHODS
  This was a randomized, double-blind, placebo-controlled study of 22 439 subjects aged 50-59 years conducted in North America and Europe. Subjects were given 1 dose of licensed zoster vaccine (ZV) (Zostavax; Merck) and followed for occurrence of HZ for ≥1 year (mean, 1.3 years) postvaccination until accrual of ≥96 confirmed HZ cases (as determined by testing lesions swabs for varicella zoster virus DNA by polymerase chain reaction). Subjects were followed for all adverse events (AEs) from day 1 to day 42 postvaccination and for serious AEs (SAEs) through day 182 postvaccination.
  
  
  RESULTS
  The ZV reduced the incidence of HZ (30 cases in vaccine group, 1.99/1000 person-years vs 99 cases in placebo group, 6.57/1000 person-years). Vaccine efficacy for preventing HZ was 69.8% (95% confidence interval, 54.1-80.6). AEs were reported by 72.8% of subjects in the ZV group and 41.5% in the placebo group, with the difference primarily due to higher rates of injection-site AEs and headache. The proportion of subjects reporting SAEs occurring within 42 days postvaccination (ZV, 0.6%; placebo, 0.5%) and 182 days postvaccination (ZV, 2.1%; placebo, 1.9%) was similar between groups.
  
  
  CONCLUSIONS
  In subjects aged 50-59 years, the ZV significantly reduced the incidence of HZ and was well tolerated.
  
  
  BACKGROUND
  NCT00534248.
authors.affiliation: Duke University, North Carolina, USA.
authors.forename: Kenneth E
authors.initials: KE
authors.lastname: Schmader
authors.forename: Myron J
authors.initials: MJ
authors.lastname: Levin
authors.forename: John W
authors.initials: JW
authors.lastname: Gnann
authors.forename: Shelly A
authors.initials: SA
authors.lastname: McNeil
authors.forename: Timo
authors.initials: T
authors.lastname: Vesikari
authors.forename: Robert F
authors.initials: RF
authors.lastname: Betts
authors.forename: Susan
authors.initials: S
authors.lastname: Keay
authors.forename: Jon E
authors.initials: JE
authors.lastname: Stek
authors.forename: Nickoya D
authors.initials: ND
authors.lastname: Bundick
authors.forename: Shu-Chih
authors.initials: SC
authors.lastname: Su
authors.forename: Yanli
authors.initials: Y
authors.lastname: Zhao
authors.forename: Xiaoming
authors.initials: X
authors.lastname: Li
authors.forename: Ivan S F
authors.initials: IS
authors.lastname: Chan
authors.forename: Paula W
authors.initials: PW
authors.lastname: Annunziato
authors.forename: Janie
authors.initials: J
authors.lastname: Parrino
mesh_terms: D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005060:Europe / Q000453:epidemiology; D005260:Female; D006562:Herpes Zoster / Q000453:epidemiology* / Q000517:prevention & control*; D053061:Herpes Zoster Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009656:North America / Q000453:epidemiology; D010919:Placebos / Q000008:administration & dosage
chemical_list: D053061:Herpes Zoster Vaccine; D010919:Placebos