GSK has reported positive interim data from the ZOSTER-049 extension study, where its recombinant, adjuvanted Zoster vaccine, Shingrix, showed to offer a minimum of ten years of protection against shingles (herpes zoster) following preliminary vaccination.
ZOSTER-049 is an open-label, long-term follow-up study from two Phase III randomised clinical trials, ZOE-50 and ZOE-70.
The study evaluated the safety, efficacy, and immunogenicity of the vaccine for six more years following the conclusion of the trials.
The vaccine demonstrated an 81.6% efficacy in the interim assessment carried out after a long-term follow-up of >4 years, indicating up to ten years since vaccination.
Efficacy of the shot was found to be 89% from a month after the second dose in initial studies up to ten years following inoculation.
The safety profile of the vaccine in the study was in line with its validated profile, without any new safety concerns detected.
A non-live, recombinant subunit vaccine, Shingrix merges a recombinant antigen, glycoprotein E, and the AS01B adjuvant system.
GSK Global Medical Regulatory & Quality said chief medical officer and senior vice-president Sabine Luik: “The findings from ZOE-LTFU demonstrate that it can provide a decade of protection against the pain, debilitating impact, and potentially severe complications that shingles can cause in people aged 50 and over.
“These data significantly add to, and complement, the existing body of evidence demonstrating the long-term benefit of the vaccine, and we look forward to seeing additional results from this ongoing study.”
In October this year, the company and Tempus entered a three-year collaboration agreement to enhance clinical trial design, expedite subject enrolment, and detect drug targets.