The FINANCIAL — GlaxoSmithKline plc on October 27 announced that the second pivotal phase III study of its candidate vaccine Shingrix in adults aged 70 years and over (known as ZOE-70) successfully met its primary objective, demonstrating 90% (95% confidence interval: 84–94) efficacy against shingles compared to placebo. The high efficacy seen in ZOE-70 is in line with the efficacy shown in the first pivotal phase III study in adults aged 50 years and over (ZOE-50) presented earlier this year i.
In addition, a pre-specified pooled analysis of ZOE-70 and ZOE-50 data demonstrated that the candidate vaccine effectively prevents subsequent chronic neuropathic pain, also known as postherpetic neuralgia (PHN) which is the most common severe complication of shingles. Shingrix was demonstrated to be 89% (95% confidence interval: 69– 97) efficacious in preventing PHN in people aged 70 years and over and 91% (95% confidence interval: 76– 98) efficacious in people aged 50 years and over, according to GlaxoSmithKline.
Based on these and the previously reported ZOE-50 data, GSK intends to submit a regulatory application for Shingrix for the prevention of shingles in people 50 years of age and over in North America, in Japan and EU during the second half of 2016.
Alain Brecx, MD, Vaccine Development Leader at GSK said: “Together, these remarkable results underscore the potential of the candidate vaccine to prevent both shingles and PHN in older adults. About 90% of people 50 years and over are at risk of developing shingles, a painful disease that negatively impacts peoples’ health and quality of life. I would like to thank all the people who participated in the two ZOE studies and the clinical investigators.”
The risk for shingles and for complications (including PHN) increases as of 50 years of age. GSK’s candidate shingles vaccine is a non-live vaccine and combines gE, a protein found on the virus that causes shingles with an adjuvant system, AS01B ii, which enhances the immunological response to gE.
The full set of safety data from the ZOE-70 trial is currently being analysed and will be disclosed in the coming months. The Independent Data Monitoring Committee (IDMC) for the ZOE-70 study, in its ongoing review of the safety data up to April 2015, did not raise any concerns. The safety profile of the candidate vaccine in older adults is based on data from more than 16,000 subjects who received the vaccine in phase I, II and III clinical trials (including ZOE-50 and 70). The most common adverse events seen in the seven days after vaccination from these studies included local symptoms (pain, redness, swelling at the injection site) and systemic symptoms (muscle pain, fatigue and headache). Data from the study are expected to be presented at a forthcoming scientific conference and submitted for publication in a peer-reviewed journal.