Efficacy, Safety, and Tolerability of Herpes Zoster Vaccine in Persons Aged 50—59 Years

• Published in: Clinical infectious diseases Vol. 54; no. 7; pp. 922 - 928
• Main Authors: Schmader, Kenneth E., Levin, Myron J., Gnann, John W., McNeil, Shelly A., Vesikari, Timo, Betts, Robert F., Keay, Susan, Stek, Jon E., Bundick, Nickoya D., Su, Shu-Chih, Zhao, Yanli, Li, Xiaoming, Chan, Ivan S. F., Annunziato, Paula W., Parrino, Janie
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.04.2012
• Subjects: Acute pain; Age groups; and Commentaries; ARTICLES AND COMMENTARIES; Biological and medical sciences; Clinical trials; Disease prevention; Double-Blind Method; Drug-Related Side Effects and Adverse Reactions - epidemiology; Europe - epidemiology; Female; Herpes viruses; Herpes zoster; Herpes Zoster - epidemiology; Herpes Zoster - prevention & control; Herpes zoster vaccine; Herpes Zoster Vaccine - administration & dosage; Herpes Zoster Vaccine - adverse effects; Herpes Zoster Vaccine - immunology; Human viral diseases; Humans; Immune response; Immunization; Incidence; Infectious diseases; Male; Medical sciences; Middle Aged; North America - epidemiology; Older adults; Pain; Placebos; Placebos - administration & dosage; Polymerase chain reaction; Postherpetic neuralgia; Vaccination; Vaccines; Viral diseases; Viral diseases with cutaneous or mucosal lesions and viral diseases of the eye; North America; Europe; Infection; Prevention; Immunoprophylaxis; Skin disease; Nervous system diseases; Herpes zoster; Viral disease; Vaccine
• ISSN: 1058-4838; 1537-6591; 1537-6591
• DOI: 10.1093/cid/cir970

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.