title: Safety and tolerability of a high-potency zoster vaccine in adults >/= 50 or years of age.
abstract: BACKGROUND
  Herpes zoster (HZ) incidence rises with age, especially after 50 years of age, probably due to waning varicella-zoster virus (VZV)-specific immunity. The Shingles Prevention Study [Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults, N Engl J Med 2005;352:2271-84], enrolled people >/= 60 or years of age and showed that zoster vaccine prevents HZ and postherpetic neuralgia (PHN), presumably through boosting VZV-specific immunity. This study of people >/= 50 or years of age compared the safety and tolerability of two zoster vaccine potencies.
  
  
  METHODS
  Adults >/= 50 or years old enrolled in a randomized, double-blind, multicenter study to compare the safety and tolerability of one dose of two zoster vaccine potencies, approximately 58,000 and approximately 207,000 plaque-forming units/dose. Adverse experiences (AEs) were recorded on a standardized Vaccination Report Card for 42 days postvaccination. For assessment of injection-site AEs, clinically acceptable tolerability was predefined based on experience with PNEUMOVAX 23, a licensed vaccine recommended for use in older people.
  
  
  RESULTS
  Six hundred and ninety-eight subjects (age 50-90 years, median 64 years) were enrolled. No serious vaccine-related AEs were reported. Similar AE rates were observed in the higher and lower potency groups (overall systemic AEs: 37.5 and 39.3%, vaccine-related systemic AEs: 10.9 and 13.2%, injection-site AEs: 63.0 and 59.8%). Rates for a combined endpoint of moderate or severe injection-site pain/tenderness/soreness and swelling were 17.2% (95% CI 13.9, 21.0) and 9.0% (95% CI 5.6, 13.4), respectively. Most combined endpoint events were reported as moderate in intensity.
  
  
  CONCLUSIONS
  Both vaccine potencies were generally well tolerated in this study of people > or years of age. Although rates of some moderate or severe injection-site AEs were greater in the higher potency group, all rates met the prespecified criteria for clinically acceptable tolerability.
authors.affiliation: University of Texas Health Science Center, Houston, TX, USA.
authors.forename: Stephen K
authors.initials: SK
authors.lastname: Tyring
authors.forename: Francisco
authors.initials: F
authors.lastname: Diaz-Mitoma
authors.forename: Larry G
authors.initials: LG
authors.lastname: Padget
authors.forename: Margarita
authors.initials: M
authors.lastname: Nunez
authors.forename: Gregory
authors.initials: G
authors.lastname: Poland
authors.forename: William M
authors.initials: WM
authors.lastname: Cassidy
authors.forename: Nickoya D
authors.initials: ND
authors.lastname: Bundick
authors.forename: Jianjun
authors.initials: J
authors.lastname: Li
authors.forename: Ivan S F
authors.initials: IS
authors.lastname: Chan
authors.forename: Jon E
authors.initials: JE
authors.lastname: Stek
authors.forename: Paula W
authors.initials: PW
authors.lastname: Annunziato
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004487:Edema; D005260:Female; D006562:Herpes Zoster / Q000517:prevention & control; D053061:Herpes Zoster Vaccine / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain
chemical_list: D053061:Herpes Zoster Vaccine