New Phase 3 Data on Shingles Vaccine Shingrix Presented at CDC Advisory Meeting

Immune response is noninferior to that of Zostavax

GlaxoSmithKline (GSK) has presented new results from a late-stage clinical study showing that its candidate vaccine for the prevention of herpes zoster (shingles) in people 50 years of age or older, Shingrix, induces a strong immune response in older adults who have been vaccinated against shingles with the currently available live-attenuated zoster (ZVL) vaccine Zostavax (Merck). The data were presented at the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meeting.

The prospective, group-matched, nonrandomized, open-label, multicenter Zoster-048 trial assessed the safety, local and systemic reactions, and immunogenicity of Shingrix in adults (65 years of age and older) who had been vaccinated against shingles with the ZVL vaccine at least five years earlier and in previously unvaccinated subjects. A total of 430 adults participated in the study.

The trial met its primary objective of demonstrating a noninferior immune response (i.e., antibody concentrations). People who received the ZVL vaccine at least five years before being vaccinated with Shingrix showed an immune response similar to that in people without previous exposure to the ZVL vaccine.

GSK has also shared the new data with the FDA and expects that the information could eventually inform a policymaking decision regarding revaccination for protection against shingles with Shingrix. The current standard of care (ZVL) provides protection against shingles, but studies suggest that this protection wanes over time, according to GSK.

Shingrix is a non-live, recombinant vaccine that combines glycoprotein E, a protein found on the varicella zoster virus (VZV), with an adjuvant system, AS01B, which is intended to enhance the immunological response to the antigen. Shingrix was submitted to the FDA for regulatory approval in October 2016. It is not currently approved for use anywhere in the world.

Shingles typically presents as a painful, itchy rash that develops on one side of the body as a result of reactivation of latent VZV, commonly known as chickenpox. Data from several countries indicate that more than 90% of adults have been infected with VZV during childhood. The individual lifetime risk in the United States of developing shingles is approximately one in three; however, this increases to one in two in people 85 years of age and older. A person's risk for shingles increases after 50 years of age because of a natural age-related decline in immune system function.

The most common complication from shingles is post-herpetic neuralgia, defined as localized pain of significant intensity persisting at least 90 days after the appearance of the acute shingles rash. Other complications include ophthalmological, neurological, and cutaneous disease, which can result in severe disability.

Source: GlaxoSmithKline; June 21, 2017.