GlaxoSmithKline (GSK) announced the publication of results from The Phase 3 study, ZOE-70, evaluating the investigational shingles vaccine, Shingrix, in patients aged 70 years and older. Detailed study findings were published in the New England Journal of Medicine (NEJM).
ZOE-70 (ZOster Efficacy in adults aged 70 years and over) was a global, multicenter, randomized, observer-blind, placebo-controlled, Phase 3 trial evaluating the efficacy, safety and immunogenicity of Shingrix in 14,800 patients aged 70 years and older. Patients received two doses of the vaccine 2 months apart. The primary endpoint was overall vaccine efficacy against shingles compared to placebo.
Analysis of the study showed that two doses of Shingrix achieved 90% efficacy vs. placebo in patients over 70 years old. Patients aged 70-79 years had 90% efficacy (95% CI: 83-94%) while patients aged 80 years and older had 89% (95% CI: 74-96%). In addition, vaccine efficacy was maintained for at least 4 years. The most common adverse events observed for the shingles vaccine were pain at the injection site and fatigue.
Efficacy outcomes from this study are consistent with results from the ZOE-50 trial, which evaluated Shingrix in patients over 50 years old. A pooled analysis of data from both trials showed that the vaccine demonstrated 91% efficacy against shingles (95% CI: 86-95%) in patients 70 years and older compared to placebo, as well as, a reduction in the risk of subsequent postherpetic neuralgia (PHN). Shingrix was 89% effective in preventing PHN in the 70 and older age group (95% CI: 68-97%) compared to 91% in the 50 and older age group (95% CI: 75-98%).
Shingrix is a non-live, subunit (HZ/su) candidate vaccine, consisting of glycoprotein E from the varicella zoster virus, and adjuvanted with AS01B.
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