GSK’s Shingrix (zoster vaccine recombinant, adjuvanted) can provide at least a decade of protection against shingles (herpes zoster) after initial vaccination, according to interim results from the company’s ZOSTER-049 extension study.
Shingles is caused by the reactivation of the varicella zoster virus, the same virus that causes chickenpox. As people age, the immune system loses the ability to mount a strong and effective immune response, increasing the risk of developing shingles.
The disease typically presents as a rash, with painful blisters across the chest, abdomen or face and, in some cases, can cause post-herpetic neuralgia pain lasting from at least three months to up to several years.
“Shingles is a painful disease that one in three adults will develop in their lifetime. We can now – for the first time – confirm that the clinical benefit of the recombinant zoster vaccine overall, continues for at least ten years after vaccination, giving patients and their healthcare providers peace of mind about the duration of protection against shingles,” said Dr Javier Díez-Domingo, principal investigator, Foundation for the Promotion of Health and Biomedical Research of the Valencian Community, Spain.
The ongoing study follows participants from the phase 3 ZOE-50 and ZOE-70 clinical trials for an additional six years, in which vaccine efficacy was 97% in adults 50 years and above and 91% in adults 70 years and above over a follow-up period of approximately four years.
In the interim analysis conducted over the ≥4 years of long-term follow-up, representing up to ten years since immunisation, vaccine efficacy was 81.6%.
The safety profile observed in the extension study is consistent with the established safety profile of the vaccine, the company reported, and no new safety concerns were identified.
Commenting on the positive results, Sabine Luik, chief medical officer and senior vice president global medical regulatory and quality, GSK, said: “We are delighted to see the continuing longevity of protection from our shingles vaccine. The findings from [ZOSTER-049] 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.
“This data significantly adds to, and complements, 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.”