GlaxoSmithKline announced results from the Phase 3 ZOE-50 trial of HZ/su, an investigational vaccine for the prevention of herpes zoster in older adults. The data was presented at the 25th Scientific Congress of the European Society of Clinical Microbiology and Infectious diseases (ECCMID) in Copenhagen and published online simultaneously in the New England Journal of Medicine.
The ZOE-50 trial is a Phase 3 randomized, placebo-controlled, multi-national study evaluating the overall vaccine efficacy (VE) of HZ/su for reducing the risk of herpes zoster in adults aged ≥50. A total of 16,160 adults participated in the trial and were randomized to receive HZ/su or a placebo (saline solution) via intramuscular injection on a 2-dose schedule and 0 and 2 months. The subject age ranges were 50–59, 60–69, 70–79, and 80 years.
Results indicate that overall vaccine efficacy was 97.2% (95% confidence interval [CI] 93.7–99.0) compared to placebo; the efficacy ranged from 96.6% in participants aged 50–59, 97.4% in those aged 60–69, 97.6% in those aged ≥60 years, and 98% in those aged ≥70 years. No significant difference in vaccine efficacy was observed among the age groups. The proportions of participants with serious adverse events, potential immune-mediated diseases, or deaths were similar in the vaccine and placebo arms.
HZ/su is an investigational non-live vaccine that combines gE with the adjuvant system AS01B1. Additional trials are underway to evaluate the efficacy of HZ/su in preventing herpes zoster in people aged ≥70 and in adults with compromised immune systems, as well as the prevention of complications from herpes zoster such as post-herpetic neuralgia (PHN).
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