GlaxoSmithKline: Shingles-vaccine study results promising

Drug company GlaxoSmithKline said recently that its phase III ZOE-50 study to assess the efficacy of HZ/su, an investigational vaccine for shingles prevention, has achieved promising results.

The study has shown that when used in adults 50 and older, HZ/su, as opposed to a placebo, reduced the risk of shingles by 97.2 percent. The study started in August 2010 and is ongoing in 18 countries, with more than 16,000 individuals participating.

“It’s great news that the ZOE-50 trial has met its primary endpoint, and I would like to thank all those involved in the clinical development program,” GSK Vaccine Development Leader Dr. Alain Brecx said. “If approved, this candidate vaccine may offer an important option for the prevention of shingles, a painful disease that negatively impacts ... 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/subclinical development program with the scientific and regulatory communities.”

HZ/su is a vaccine that combines gE, a protein that causes shingles, with an adjuvant system, AS01B1, which is intended to strengthen the immunological response.

The full set of data from the ZOE-50 trial is undergoing analysis and will be disclosed in the coming months, but the Independent Data Monitoring Committee for the study has not raised any concerns regarding the continuation of the trial. Data are expected to be presented at a future scientific conference and submitted for publication in a peer-reviewed journal.

Additional trials to evaluate the efficacy of HZ/su are underway in those with shingles aged 70 and older and in immunocompromised people.