GlaxoSmithKline has unveiled full data from a Phase III trial of its shingle vaccine HZ/su, showing a high level of protection across all age groups studied.
Analysis of the primary endpoint showed that a two-dose schedule of HZ/su cut the risk of herpes zoster by 97.2% (95% confidence interval) in adults aged 50 years and older compared to placebo.
Vaccine efficacy was maintained across the various age studies, ranging between 96.6% in people aged 50-59 years, 97.4% in those aged 60-69 years, 97.6% in people aged 60 years and above, and 98% in those 70 years or older, the firm said.
On the safety side, the proportion od subjects with serious adverse events, potential immune-mediated diseases, or deaths were similar in vaccine and placebo groups, with the most commonly reported local adverse reaction being pain, redness and swelling at the injection site.
HZ/su is an experimental vaccine that combines gE, a protein found on the virus that causes shingles, with an adjuvant system, AS01B, designed to enhance the immunological response.
If approved, HZ/su could significantly eat into sales of the only approved product on the market - Merck & Co's Zostavax - which overall (in persons age 60 years and older) reduces the occurrence of shingles by about 50%.