GSK Presents Positive Results from Phase 3 Shingrix Study

GSK will be presenting new results from a clinical study showing that its candidate vaccine for the prevention of herpes zoster (shingles) in people aged 50 years or older, Shingrix (HZ/su), induces a strong immune response in older adults who have previously been vaccinated against shingles with the currently available live-attenuated zoster vaccine (ZVL). The results of the Zoster-048 study will be presented today at the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) meeting.

The study met its primary objective of demonstrating non-inferior immune response (i.e. antibody concentrations). People who received the ZVL vaccine at least 5 years prior to being vaccinated with Shingrix showed a similar immune response to people without previous exposure to the ZVL vaccine. In addition, Shingrix was well-tolerated in both study groups when assessed up to one month after the second dose of Shingrix.

GSK is sharing these data on safety, local and systemic reactions, and immunogenicity with the US Food and Drug Administration (FDA) and expects that the data could eventually inform a policymaking decision regarding revaccination for protection against shingles with Shingrix. The ongoing study of 430 adults aged 65 years and older was designed as a prospective, group-matched, non-randomised, open-label, multicentre trial in those previously vaccinated with ZVL at least 5 years earlier and in previously unvaccinated subjects.

The current standard of care ZVL provides protection against shingles, but studies suggest that this protection wanes over time.

Dr. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines said: “We are encouraged by these results, which indicate that Shingrix can be an option for adults over 50 years of age, who previously received the currently available vaccine and are seeking to benefit from revaccination with Shingrix, if recommended.”

Zoster-048 is focused on the immune response and safety of Shingrix, rather than efficacy, and builds on previously released clinical trial data where the immunogenicity and efficacy were tested simultaneously. The most common local and systemic reactions were in line with previous observations and no clinically significant safety signs were observed.

In two separate phase III studies, ZOE-50 and ZOE-70, Shingrix demonstrated efficacy against shingles above 90%, independent of age (>50, >70, >80 years of age), as well as sustained efficacy over the entire follow-up period of 4 years.

The study presented today has been submitted for publication in a peer-reviewed scientific journal.

The candidate shingles vaccine, Shingrix, was submitted for regulatory approval to the FDA in October 2016, to Canadian regulatory authorities and the European Medicines Agency in November 2016, and to Japanese regulatory authorities in April 2017. Shingrix is not currently approved for use anywhere in the world.