The efficacy of Shingrix was 97% in adults 50 years of age and older and 91% in adults 70 years of age and older over an extended follow-up period.
Zoster vaccine recombinant, adjuvanted (Shingrix, GSK) may provide at least a decade of protection against herpes zoster after initial vaccination, according to results from the ZOSTER-049 extension study.
The Shingrix combines a recombinant antigen, glycoprotein E and the adjuvant system, AS01B. The recombinant zoster vaccine (RZV) is the first approved shingles immunization to combine a non-live antigen with GSK’s adjuvant. The vaccine may help inhibit the natural age-related reduction in immunity, which exacerbates the difficulty in protecting individuals 50 years of age and older from shingles.
“Shingles is a painful disease that 1 in 3 adults will develop in their lifetime,” Dr Javier Díez-Domingo, principal investigator, Foundation for the Promotion of Health and Biomedical Research of the Valencian Community, Spain, said in a press release. “We can now—for the first time—confirm that the clinical benefit of the recombinant zoster vaccine overall, continues for at least 10 years after vaccination, giving patients and their health care providers peace of mind about the duration of protection against shingles.”
In the United States, RZV is licensed for prevention of shingles in adults 50 years of age and older, and in adults 18 years of age and older who are, or will be, at an increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy.
Shingles typically presents as a rash, characterized by painful blisters across the chest, abdomen, and face. Patients describe the pain as aching, burning, stabbing, or shock-like. A patient with a rash can experience post-herpetic neuralgia (PHN) pain lasting from at least 3 months up to several years from the onset of rash.
ZOSTER-049 was an extension from a pair of phase 3 clinical trials, ZOE-50 and ZOE-70, in which the efficacy of Shingrix was 97% in adults 50 years of age and older and 91% in adults 70 years of age and older over a follow-up period of approximately 4 years. The study included 7413 participants, of whom 60.7% were female and 39.3% were male, 76% were White, 18.7% Asian, and 5.3% Other.
The ZOE-LTFU study, which follows participants from the ZOE-50 and ZOE-70 clinical trials for an additional 6 years, is ongoing and will continue to evaluate the longer-term efficacy, immunogenicity, and safety of the vaccine.
The safety profile that was observed in ZOSTER-049 was consistent with the established safety profile of the vaccine, with no new concerns identified. There were no deaths or other adverse events considered related to vaccination reported, but there were 5 cases of herpes zoster-related complications.
“We are delighted to see the continuing longevity of protection from our shingles vaccine,” Sabine Luik, chief medical officer and SVP Global Medical Regulatory and Quality, GSK, said in the release. “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.”
New data show Shingrix can provide at least 10 years of protection against shingles in adults aged 50 years and over. GSK. October 19, 2022. Accessed October 21, 2022. https://www.gsk.com/en-gb/media/press-releases/new-data-show-shingrix-can-provide-at-least-10-years-of-protection-against-shingles-in-adults-aged-50-years-and-over/