An investigational shingles vaccine developed by global pharmaceutical and healthcare company GlaxoSmithKline (NYSE: GSK) is showing high efficacy against the ailment and various complications in adults over 70, according to a press release issued by the company on Wednesday, September 14. The findings are included in the results of a randomized phase III study (ZOE-70) of the Shingrix™ vaccine, published in the New England Journal of Medicine.
The ZOE-70 study, conducted on more than 14,800 subjects in North America, Latin America, Europe and Asia-Pacific, shows that the candidate shingles vaccine, administered in two doses, has an efficacy rate of 90% in subjects aged 70 and over. The efficacy of the vaccine was maintained across various age groups, at a rate of 89-90%. The results confirm a previous study (ZOE-50) conducted on people over 50 years old, which indicated that Shingrix had a 97% efficacy. A joint analysis of both studies’ findings concluded that the vaccine has an overall 91% efficacy against shingles in people over 70, an efficacy maintained for at least four years after inoculation, with an 88% drop in the risk of developing the disease.
Both studies also showed that the candidate vaccine is efficient against one of the most common and severe complications of shingles: postherpetic neuralgia (PHN), with 89% efficacy in preventing this chronic neuropathic pain in people over 70 years and 91% efficacy in people aged 50 and over.
Possible side effects of Shingrix reported during the ZOE-70 study were typically mild to moderate in intensity and consisted of pain at the injection site and fatigue. Most systemic and injection site reactions were reported within seven days of vaccination and lasted for three days at most.
The results of the ZOE-70 study were praised as “remarkable” by GSK Senior Vice President for Vaccines Research and Development Dr. Emmanuel Hanon. He explained this was the first time such a high efficacy rate was reported for older people and that, if approved, Shingrix could become a significant tool for the prevention of shingles and associated pain. ZOE-70 study Principal Investigator and Westmed Institute for Medical Research in Australia Executive Director Anthony Cunningham also underlined the high efficacy of the vaccine against herpes zoster in people over 70 and 80, the age groups most typically affected by this ailment.
Based on the results of both ZOE-70 and ZOE-50 studies, GSK expects to submit regulatory applications for the shingles vaccine later this year. The vaccine combines a protein found on the varicella zoster virus that causes shingles, called glycoprotein E, with an adjuvant designed to increase immunological response to the antigen.
Shingles typically develops as a painful rash on one side of the body, caused by the reactivation of the latent varicella zoster virus, or chickenpox virus. Anyone ever infected with this virus is at risk of developing shingles, but the disease is typically prevalent in older adults (over 50) or people with weakened immune systems. It is estimated that approximately one in three people in the U.S. are at risk of developing shingles, but the risk increases to one in two people for individuals who are 85 or over.
For more information, visit www.gsk.com
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