PMID- 22291101
OWN - NLM
STAT- MEDLINE
DCOM- 20120709
LR  - 20220409
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Print)
IS  - 1058-4838 (Linking)
VI  - 54
IP  - 7
DP  - 2012 Apr
TI  - Efficacy, safety, and tolerability of herpes zoster vaccine in persons aged 50-59 
      years.
PG  - 922-8
LID - 10.1093/cid/cir970 [doi]
AB  - 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. CLINICAL TRIALS REGISTRATION: 
      NCT00534248.
FAU - Schmader, Kenneth E
AU  - Schmader KE
AD  - Duke University, North Carolina, USA.
FAU - Levin, Myron J
AU  - Levin MJ
FAU - Gnann, John W Jr
AU  - Gnann JW Jr
FAU - McNeil, Shelly A
AU  - McNeil SA
FAU - Vesikari, Timo
AU  - Vesikari T
FAU - Betts, Robert F
AU  - Betts RF
FAU - Keay, Susan
AU  - Keay S
FAU - Stek, Jon E
AU  - Stek JE
FAU - Bundick, Nickoya D
AU  - Bundick ND
FAU - Su, Shu-Chih
AU  - Su SC
FAU - Zhao, Yanli
AU  - Zhao Y
FAU - Li, Xiaoming
AU  - Li X
FAU - Chan, Ivan S F
AU  - Chan IS
FAU - Annunziato, Paula W
AU  - Annunziato PW
FAU - Parrino, Janie
AU  - Parrino J
LA  - eng
SI  - ClinicalTrials.gov/NCT00534248
GR  - P30 AG028716/AG/NIA NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120130
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
RN  - 0 (Herpes Zoster Vaccine)
RN  - 0 (Placebos)
SB  - IM
CIN - Clin Infect Dis. 2012 Apr;54(7):929-30. PMID: 22291102
CIN - Clin Infect Dis. 2012 Sep;55(6):889-90; author reply 889-90. PMID: 22696015
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Europe/epidemiology
MH  - Female
MH  - Herpes Zoster/*epidemiology/*prevention & control
MH  - Herpes Zoster Vaccine/administration & dosage/*adverse effects/*immunology
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - North America/epidemiology
MH  - Placebos/administration & dosage
PMC - PMC4542655
EDAT- 2012/02/01 06:00
MHDA- 2012/07/10 06:00
PMCR- 2013/04/01
CRDT- 2012/02/01 06:00
PHST- 2012/02/01 06:00 [entrez]
PHST- 2012/02/01 06:00 [pubmed]
PHST- 2012/07/10 06:00 [medline]
PHST- 2013/04/01 00:00 [pmc-release]
AID - cir970 [pii]
AID - 10.1093/cid/cir970 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2012 Apr;54(7):922-8. doi: 10.1093/cid/cir970. Epub 2012 Jan 30.