GSK commences Phase III clinical trials to develop herpes zoster vaccine for the prevention of shingles
GlaxoSmithKline confirmed that the company has commenced the Phase III clinical trials programme of its candidate herpes zoster vaccine currently being developed for the prevention of shingles. The phase III clinical trials will study more than 30,000 patients globally and will evaluate the efficacy, safety and immunogenicity of the candidate vaccine.
"The commencement of the Phase III programme for our candidate herpes zoster vaccine is a significant milestone," said Norman Begg, Chief Medical Officer of GSK Biologicals. "Shingles is an often debilitating condition for which there are limited treatment and prevention options. That is why progression into late stage development of our herpes zoster vaccine is an important milestone in ongoing efforts to potentially help address an important unmet need."
About shingles and herpes zoster
Herpes Zoster (HZ) or zoster is commonly known as shingles. It is caused by varicella-zoster virus (VZV). HZ occurs at all ages with an estimated 1 million HZ cases per year in the United States1. The overall incidence of herpes zoster in Europe is approximately 3 per 1000 people per year and more than 10 per 1000 people per year in those aged >80 years(2). The incidence of HZ increases with age(3).
GlaxoSmithKline Biologicals (GSK Biologicals), GlaxoSmithKline's vaccines business, is one of the world's leading vaccine companies and a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. For further information please visit www.gsk.com.
1. Shingles Disease: Questions and Answers (Herpes Zoster)
2. Valhi A, Gross G, Hercogova J, Johnson RW. Current Management of herpes zoster: the European View. Am J Clin Dermatol 2005; 6 (5): 317 - 25
3. Oxman MN, Levin MJ, Johnson GR et al. Shinlges Prevention Study Group. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl. J. Med 2005; 352: 2271 – 2284.