Date: 2015-04-28
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 25th Scientific Congress of the European Society of Clinical Microbiology and Infectious diseases (ECCMID) in Copenhagen
Company: GSK (UK) Agenus (USA - MA)
Product: herpes zoster vaccine (HZ/su) containing Agenus\' QS-21 Stimulon®1 adjuvant
Action
mechanism: HZ/su is a new candidate vaccine that combines gE, a protein found on the virus that causes shingles, with an adjuvant system, AS01B,1 which is intended to enhance the immunological response.
Disease: shingles
Therapeutic area: Infectious diseases
Country:
Trial
details: The ZOE-50 Zoster efficacy in adults aged 50 years and over study is a randomised, observer-blind, placebo-controlled (saline solution) multicentre, multinational (North America, Europe, Latin America, Asia-Pacific) phase III trial involving 16,160 adults aged 50 years and older. The study started in August 2010 and reported headline efficacy data in December 2014. Doses were given intramuscularly on a 2-dose schedule at 0 and 2 months. The primary endpoint of this study is the overall vaccine efficacy (VE) of the candidate vaccine HZ/su across all age cohorts compared to placebo in reducing the risk of developing shingles. The study includes subjects in the age ranges 50-59, 60-69, 70-79, and ³80 years.
Latest
news: * On April 28, 2015, GSK presented detailed data from a randomised phase III study of its investigational vaccine candidate for the prevention of shingles, HZ/su, showing vaccine efficacy was maintained across age groups, from 50 years to 70 years and over. 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. Analysis of the primary endpoint showed that a two-dose schedule of HZ/su reduced the risk of herpes zoster by 97.2% (95% confidence interval [CI] 93.7-99.0) in adults aged 50 years and older compared to placebo. Vaccine efficacy was maintained across the various age groups included in the study, 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. There was no significant difference in vaccine efficacy among the age groups. The proportions of subjects with serious adverse events, potential immune-mediated diseases, or deaths were similar in vaccine and placebo groups. The most commonly reported local adverse reaction was pain with the others being redness and swelling at the injection site. These were graded severe in 9.5% of HZ/su recipients compared to 0.4% of placebo recipients. The more frequently reported systemic adverse reactions were muscle pain, fatigue and headache, of which 11.4% were graded severe in the HZ/su group compared to. 2.4% in the placebo group. These reactions mostly occurred within 7 days of vaccination with most lasting 1-3 days. Additional trials to evaluate the ability of HZ/su to prevent shingles are ongoing in people aged 70 and older and in adults with compromised immune systems. These studies will provide additional information with respects to the safety of HZ/su and its ability to stimulate immune responses in specific populations. These studies will also address the degree to which HZ/su can prevent complications of shingles, such as chronic neuropathic pain, also known as post-herpetic neuralgia (PHN). * On December 18, 2014, GSK announced that a pivotal phase III study to assess the efficacy of HZ/su, an investigational vaccine for the prevention of shingles, has met its primary endpoint. Analysis of the primary endpoint showed that HZ/su reduced the risk of shingles by 97.2 per cent in adults aged 50 years and older compared to placebo. These are the first results from the ZOster Efficacy study in adults aged 50 years and over (ZOE-50). The study, which started in August 2010, is ongoing in 18 countries and involves more than 16,000 individuals. The full set of safety data from the ZOE-50 trial is currently being analysed and will be disclosed in the coming months. The Independent Data Monitoring Committee (IDMC) for the ZOE-50 study, in its ongoing review of the safety information up to 31 May 2014, raised no concerns regarding the continuation of the trial. At this time, the safety profile of HZ/su in older adults is based on data from more than 440 subjects who received HZ/su in phase I and II clinical trials. The most common adverse events seen with HZ/su from these studies included local reactions (pain, redness, swelling at the injection site) and systemic symptoms (muscle pain, fatigue and headache). Data from the ZOE-50 trial are expected to be presented at a forthcoming scientific conference and submitted for publication in a peer-reviewed journal. An additional GSK trial to evaluate the ability of HZ/su to prevent shingles is underway in adults aged 70 and older (ZOE-70). This study will provide additional information on the efficacy of HZ/su vaccine candidate in preventing some of the complications of shingles, the most common being chronic neuropathic pain, also known as post-herpetic neuralgia (PHN)[i].
