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Shingles Vaccine Provides 97% Protection in Late-Stage Trial
Primary and secondary endpoint data from a phase III study of HZ/su (GlaxoSmithKline/Agenus, Inc.), a vaccine candidate for the prevention of shingles, have been simultaneously presented at the 25th scientific conference of the European Society of Clinical Microbiology and Infectious Disease (ECCMID) in Copenhagen, Denmark, and published in the New England Journal of Medicine. GSK’s HZ/su incorporates Agenus’ QS-21 Stimulon adjuvant, which is designed to increase the immune response to antigens.
In the new study, HZ/su reduced the risk of shingles (herpes zoster) by 97.2% in adults aged 50 years and older compared with placebo. Importantly, the protection was maintained across all age groups, ranging from 96.6% in subjects aged 50 to 59 years; 97.4% in those aged 60 to 69 years; and 97.9% in those 70 years of age or older.
No major safety concerns were identified in the study. The most common adverse events were injection-site pain, fatigue, and myalgia.
The HZ/su vaccine candidate combines gE, a protein that is part of the virus that causes shingles, with the AS01 adjuvant system, which enhances the immune response to gE. The AS01 adjuvant system contains Agenus’ QS-21 Stimulon, MPL (3-O-desacyl-4’-monophosphoryl lipid A), and liposomes.
QS-21 Stimulon is a saponin extracted from the bark of the Quillaja saponaria tree, an evergreen also known as the soap bark tree. The adjuvant is a key component of investigational vaccines to prevent a variety of infectious diseases. It is also a key component of therapeutic vaccines for cancer and degenerative disorders.
The HZ/su shingles study is a randomized, observer-blinded, placebo-controlled trial involving more than 16,000 adults 50 years of age and older. The study started in August 2010 and is still ongoing. In addition to older adults, HZ/su is being evaluated in immunocompromised populations, including patients with solid and hematological cancers, hematopoietic stem-cell and renal-transplant recipients, and individuals with human immunodeficiency virus (HIV) infections.
Shingles typically presents as a painful, itchy rash that develops on one side of the body as a result of the reactivation of latent varicella zoster (chickenpox) virus. Complications from shingles can include chronic pain, scarring, vision complications, secondary infection, nerve palsies, and hospitalization. A person’s risk for shingles increases sharply after the age of 50. The individual lifetime risk of developing shingles is approximately one in three people; however, for individuals 85 years of age and older, this risk increases to one in two people.
Source: Agenus, Inc.; April 28, 2015.