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Novel Experimental Shingles Vaccine

Darrell Hulisz, RPh, PharmD

September 8, 2015

Herpes zoster, also known as shingles, results from the reactivation of dormant varicella zoster virus several years after infection with chicken pox. Shingles more commonly affects adults older than 50 and those who are immunocompromised. More than 90% of adults aged 50 years and older are at risk for developing shingles. While shingles is typically a self-limited disorder, some patients can develop severe complications, such as post herpetic neuralgia, leading to chronic neuropathic pain. This complication is much more common in elderly patients. A live-attenuated vaccine against herpes zoster (Zostavax) has been licensed in the US for several years and is approved for adults 50 years old or greater. However, its efficacy against herpes zoster is markedly diminished in the elderly, especially in those older than 70. A novel single-protein recombinant subunit vaccine has shown great promise in recent study. The vaccine contains varicella zoster virus (non-live) with a subunit antigen system. The vaccine, known as HZ/su combines glycoprotein E, a protein found on the virus that causes shingles, with an adjuvant system, known as AS01B to enhance the immunological response.

A recent clinical trial, the Zoster Efficacy Study in Adults 50 Years of Age or Older Study (ZOE-50), demonstrated that two doses of HZ/su significantly lowered the risk for shingles among adults age 50 years and older. In this prospective clinical trial subjects, over 15,000 patients were stratified according to age group: 1) 50-59 years, 2) 60-69 years, and 3) 70 years and older. Subjects received either two intramuscular doses of HZ/su vaccine or placebo separated by two months. During the mean follow-up of 3.2 years, only 6 participants in the vaccine group developed herpes zoster, and 210 participants in the placebo group developed shingles. The overall efficacy of HZ/su against herpes zoster was between 96.6% and 97.9% for all age groups, with 97.2% efficacy overall. In contrast to previous clinical trials with Zostavax, HZ/su vaccine effectiveness did not diminish with age. Injection site reactions, such as redness and swelling were more common in the HZ/su group, relative to placebo. It is not yet clear how many years immunity would be sustained since the mean follow-up period in ZOE-50 was 3.2 years. An ongoing study known as ZOE-70 includes adults who are 70 years and older will determine HZ/su vaccine efficacy against post-herpetic neuralgia and other complications of herpes zoster in this older age group. While the results of ZOE-50 are encouraging, it is likely the vaccine will remain experimental until the ZOE-70 study is complete.

1. Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang SJ, Levin MJ, McElhaney JE, Poder A, Puig-Barbera J, Vesikari T, Watanabe D, Weckx L, Zahaf T, Heineman TC; ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015 May 28;372(22):2087-96

2. Barclay L. Newer herpes zoster vaccine effective even in older adults. Medscape April 30, 2015. http://www.medscape.com/viewarticle/843998Accessed on August 24, 2015.


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