GSK announced the publication of detailed results from a randomised phase III study (ZOE-70) of its investigational shingles vaccine, Shingrix™, showing 90% efficacy in adults aged 70 years and older that is maintained for at least four years. The results were published in the New England Journal of Medicine (NEJM).
The study, from which headline results were reported in October 2015, showed that the two-dose candidate shingles vaccine had 90% efficacy (95% confidence interval: 84-94%) compared to placebo in people over 70 years old. Vaccine efficacy was maintained across the various age groups included in the study, ranging between 90% in people aged 70-79 years (95% confidence interval: 83-94%) and 89% in those aged 80 years and above (95% confidence interval: 74-96%).
The high efficacy is in line with the results of the ZOE-50 trial, a study in people over 50 years old which was presented and published last year showing a 97% efficacy (95% confidence interval: 93-99%). A pooled analysis of data from both trials showed the vaccine demonstrated 91% efficacy against shingles (95% confidence interval: 86-95%) in adults aged 70 years and older compared to placebo. This efficacy was maintained with an 88% reduction in the risk of shingles (95% confidence interval: 73-95%) in the fourth year after vaccination.
The risk of serious adverse events, potential immune-mediated diseases or deaths observed in ZOE-70 was similar in people receiving Shingrix and placebo. The most commonly reported local adverse reaction was pain at the injection site and the most frequently reported systemic adverse reaction was fatigue. The majority of injection site and systemic reactions occurred within seven days of vaccination, with most lasting 1-3 days, and generally were mild-to-moderate in intensity.
Dr Emmanuel Hanon, Senior Vice President, Vaccines Research and Development, GSK, said: “This is the first time that such high efficacy has been demonstrated in a vaccine candidate for older people and it is remarkable, as we know that these people frequently have an age-related weakening of their immune system. If approved, this candidate vaccine could be an important tool for the prevention of shingles and the pain associated with it, which would significantly impact the health and quality of life of so many people.”