Phase III trial of Shingrix vaccine meets primary endpoint in shingles- GlaxoSmithKline

GlaxoSmithKline 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 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.

The results of the Zoster-048 study will be presented at the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) meeting. 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.