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Pivotal Study of Shingles Vaccine Meets Primary Endpoint

Risk reduced by 97% in subjects 50 years of age and older

A pivotal phase III study to assess the efficacy of HZ/su (GlaxoSmithKline), 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% in adults aged 50 years and older compared with placebo.

This is the first result from the ZOster Efficacy Study in Adults Aged 50 Years and Older (ZOE-50). The study, which started in August 2010, is continuing in 18 countries and involves more than 16,000 individuals.

HZ/su is a new candidate vaccine that combines gE, a protein found on the virus that causes shingles, with an adjuvant system, AS01B, which is intended to enhance the immunological response.

The independent data-monitoring committee for the ZOE-50 study, in its ongoing review of the safety information up to May 31, 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 the vaccine in phase I and II clinical studies. The most common adverse events associated with HZ/su in these studies included local reactions (pain, redness, and swelling at the injection site) and systemic symptoms (muscle pain, fatigue, and headache).

Additional studies to evaluate the ability of HZ/su to prevent shingles are under way in subjects aged 70 years and older and in immunocompromised subjects. These studies will evaluate the efficacy, safety, and immunological response of HZ/su in specific populations and whether the treatment can prevent some of the complications of shingles, such as chronic neuropathic pain, also known as post-herpetic neuralgia (PHN).

The ZOE-50 study is a phase III, randomized, observer-blinded, placebo-controlled, multinational trial involving 16,160 subjects aged 50 years and older. Doses of the HZ/su vaccine were given intramuscularly on a 2-dose schedule at 0 and 2 months. The study’s primary endpoint is the overall vaccine efficacy (VE) of the candidate vaccine across all age cohorts compared with placebo in reducing the risk of developing shingles. The study includes subjects in the age ranges of 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80 years or more.

Shingles typically presents as a painful, itchy rash that develops on one side of the body as a result of reactivation of latent varicella zoster virus (VZV). Anyone who has been infected with VZV is at risk of developing shingles, with age and an altered immune system recognized as the main risk factors. Complications from shingles can include scarring, vision complications, secondary infection, nerve palsies, and PHN, the most common complication.

Data from many countries indicate that more than 90% of adults are at risk for herpes zoster (HZ), and that a person’s risk for shingles increases sharply after 50 years of age. The risk of complications, including PHN and hospitalization, also increase with age. The individual lifetime risk of developing HZ is approximately one in three people; however, for individuals aged 85 years and older, the risk increases to one in two people.

Source: GlaxoSmithKline; December 18, 2014.

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