LONDON (dpa-AFX) - GlaxoSmithKline PLC (GSK.L, GSK) said it will present 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 or ZVL.
The company noted that 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 said it 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.
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