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

TLDR

Herpes zoster adversely affects people aged 50‑59, yet its vaccine efficacy in this group had not been evaluated. The study aimed to assess the efficacy, safety, and tolerability of the zoster vaccine in preventing herpes zoster among adults aged 50‑59. In a randomized, double‑blind, placebo‑controlled trial of 22,439 adults, participants received a single dose of Zostavax and were monitored for herpes zoster and adverse events for up to 1.3 years. The vaccine achieved 69.8% efficacy, reducing herpes zoster incidence from 6.57 to 1.99 per 1,000 person‑years, and was well tolerated with higher injection‑site reactions but comparable serious adverse events. Trial registered under NCT00534248.

Abstract

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.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.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.In subjects aged 50-59 years, the ZV significantly reduced the incidence of HZ and was well tolerated.NCT00534248.