News Feature | December 23, 2014

GSK's Phase 3 Study For Shingles Vaccine Hits Endpoint

By Estel Grace Masangkay

GlaxoSmithKline announced positive results from its pivotal Phase 3 study investigating its vaccine HZ/su for the prevention of shingles.

HZ/su is a candidate vaccine that comprises gE, a protein expressed on the virus that causes shingles, and an adjuvant system, AS01B,1 which boosts the immunological response.

The company reported that analysis of the primary endpoint of the ZOster Efficacy study in adults aged 50 years and over (ZOE-50) study showed that the HZ/su vaccine cut the risk of developing shingles by 97.2 percent in adults. The ZOE-50 study was launched in August 2010 and is presently ongoing in 18 countries involving over 16,000 individuals.

Alain Brecx, MD, Vaccine Development Leader at GSK, said, “It’s great news that the ZOE-50 trial has met its primary endpoint… If approved, this candidate vaccine may offer an important option for the prevention of shingles, a painful disease that negatively impacts peoples’ health and quality of life. We look forward to sharing these compelling results and additional data from the ZOE-50 study and the broader HZ/suclinical development program with the scientific and regulatory communities.”

GSK is also investigating the vaccine in additional clinical studies in individuals 70 years old or older, as well as in immunocompromised people. The vaccine’s efficacy, safety, and immunological response will be assessed, along with its ability to prevent potential complications of shingles, including chronic neuropathic pain, also known as post-herpetic neuralgia (PHN).

Results from the ZOE-50 trial are anticipated to be revealed at an upcoming scientific conference and to be published in a peer-reviewed journal.

Reuters reports that the strong performance of GSK’s vaccine will help it catch up with rival Merck’s Zostavax, projected to reach $1.1 billion in sales by 2019, according to Thomson Reuters Cortellis based on its forecast compilation. In contrast, UBS predicted that GSK’s HZ/su might exceed $1 billion a year, thanks to its superior efficacy.