"GSK LSENYSE GSK httpstudio.financialcontent.comprnewsPageQuoteTickerGSK today announced the publication of detailed results from a randomised phase III study ZOE of its investigational shingles vaccine Shingrix showing  efficacy in adults aged  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  showed that the twodose candidate shingles vaccine had  efficacy  confidence interval  compared to placebo in people over  years old. Vaccine efficacy was maintained across the various age groups included in the study ranging between  in people aged  years  confidence interval  and  in those aged  years and above  confidence interval . The high efficacy is in line with the results of the ZOE trial a study in people over  years old which was presented and published last year showing a  efficacy  confidence interval . A pooled analysis of data from both trials showed the vaccine demonstrated  efficacy against shingles  confidence interval  in adults aged  years and older compared to placebo. This efficacy was maintained with an  reduction in the risk of shingles  confidence interval  in the fourth year after vaccination.  The risk of serious adverse events potential immunemediated diseases or deaths observed in ZOE 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  days and generally were mildtomoderate in intensity. In addition a pooled analysis of data from the ZOE and ZOE trials showed that the candidate vaccine effectively reduced the risk of subsequent chronic neuropathic pain also known as postherpetic neuralgia PHN which is the most common and often severe complication of shingles. The candidate vaccine was shown to be   confidence interval  efficacious in preventing PHN in people aged  years and older and  efficacious  confidence interval  in people aged  years and over.  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 agerelated 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. Anthony Cunningham Executive Director of the Westmead Institute for Medical Research in Australia and Principal Investigator of the ZOE study said These data show that this investigational vaccine maintains high efficacy against herpes zoster in people over  and  years of age the age groups who are most affected by the disease. Importantly it also prevents a common and feared complication of herpes zoster prolonged pain or post herpetic neuralgia in these groups. Based on these and the previously reported ZOE data GSK expects to start submitting regulatory applications for the candidate vaccine for the prevention of shingles in people  years and above later this year. About Shingrix Shingrix is a nonlive adjuvanted subunit  HZsu candidate vaccine to help prevent herpes zoster and its complications. The candidate vaccine combines glycoprotein E a protein found on the varicella zoster virus VZV that causes shingles with an adjuvant system ASB which is intended to enhance the immunological response to the antigen.  Additional trials to evaluate the ability of Shingrix to help prevent shingles are ongoing in healthy people aged  and older and in adults with compromised immune systems. These studies will provide additional information with respect to the efficacy and safety profile of the candidate vaccine  as well as its ability to stimulate immune responses in other populations and in specific circumstances.  Notes to editors The name Shingrix is not yet approved for use by regulatory authorities in most countries including the US Food and Drug Administration FDA.  About the ZOE trial The ZOE ZOster Efficacy in adults aged  years and over NCT study is a randomised observerblind placebocontrolled saline solution multicentre multinational North America Europe Latin America AsiaPacific phase III trial involving more than  adults aged  years and older. Two doses were given intramuscularly two months apart. The study which started in August  in parallel with the ZOE trial includes subjects in the age ranges  and  years. The primary objective of ZOE is overall vaccine efficacy against shingles in people  years and over compared to placebo. The coprimary objectives of the pooled analysis over both studies are the assessment of overall vaccine efficacy in reducing the risk of developing shingles and PHN in people aged  years and over using pooled data from both ZOE and ZOE studies. About the ZOE trial The ZOE ZOster Efficacy in adults aged  years and over NCT study is a randomised observerblind placebocontrolled saline solution multicentre multinational North America Europe Latin America AsiaPacific phase III trial involving  adults aged  years and older. The study started in August . Two doses were given intramuscularly two months apart. The primary objective of this study is the overall vaccine efficacy against shingles in people aged  years or older compared to placebo. The study includes subjects in the age ranges    and  years. About the phase III study programme Involving more than  subjects globally the phase III programme for GSKs candidate shingles vaccine evaluates its efficacy safety and immunogenicity. In addition to older adults the candidate vaccine is being evaluated in immunocompromised patient populations including solid and haematological cancer patients haematopoietic stem cell and renal transplant recipients and HIVinfected people. About shingles Shingles typically presents as a painful itchy rash that develops on one side of the body as a result of reactivation of latent chickenpox virus varicella zoster virus VZV. Anyone who has been infected with VZV is at risk of developing shingles with age and altered immune system being recognised as the main risk factors. Complications from shingles can include PHN the most common complication scarring vision complications secondary infection and nerve palsies.PHN is often defined as a localized pain of significant intensity persisting at least  days after the appearance of the acute shingles rash. Data from many countries indicate that older adults aged  and over are at highest risk for shingles as more than  of older adults have been infected with wild type VZV. A persons risk for shingles increases sharply after  years of age. Risk of complications including PHN and hospitalisation also increase with age. The individual lifetime risk of developing shingles is approximately one in three for people in the USA however for individuals aged  and over this risk increases to one in two people. References . Cunningham et al. N Engl J Med   . Efficacy of the herpes zoster subunit vaccine in adults  years of age or older.  . Lal et al. N Engl J Med    Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults  . Shingles Herpes Zoster Clinical Overview. US Centers for Disease Control and Prevention. Accessed at http on  Sept .  . Cohen et al. N Engl J Med  Clinical practice Herpes zoster.  . The GSK proprietary AS adjuvant system contains QS Stimulon adjuvant licensed from Antigenics Inc a wholly owned subsidiary of Agenus Inc. 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