Research Praises Shingles Vaccine Efficacy

Herpes zoster (HZ), more commonly known as shingles, is a vaccine-preventable disease with potentially debilitating complications that greatly decrease quality of life.

Shingrix, a vaccine indicated for the prevention of herpes zoster in adults aged 50 years or older and those aged 18 years or older who are at a higher risk of getting shingles, is gaining a lot of prominence with recent studies proving its effectiveness.

One such study¹ reveals that Shingrix provides a high level of protection against herpes zoster for up to 8 years after administration and the recombinant zoster vaccine (RZV) remains effective.

The ZOSTER-049 extension study follows 2 pivotal prelicensure phase III randomized clinical trials—known as ZOE-50 and ZOE-70—where RZV demonstrated 97% and 90% efficacy against HZ in adults aged 50 to 70 years over a median follow-up of 3.1 and 3.7 years, respectively. In fact, nearly 10 years after vaccination with RZV, an interim analysis in this follow-up study of the ZOE-50/70 trials demonstrated that efficacy against HZ remained high as the years went on.

Moreover, the safety profile remained clinically acceptable, suggesting that the clinical benefit of the RZV in people aged ≥50 years is sustained up to 10 years.

“Shingles is a painful disease that 1 in 3 adults will develop in their lifetime,” said Javier Díez-Domingo, principal investigator for the Foundation for the Promotion of Health and Biomedical Research of the Valencian Community in Spain, “We can now—for the first time—confirm that the clinical benefit of the RZV 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.”

New published data shows Shingrix offers sustained protection against herpes zoster in adults aged 50 years and older, with a clinically acceptable safety profile in the long term.

In a study, 7413 participants enrolled in a long-term efficacy assessment, with 7277 included in the modified total vaccinated cohort (mTVC), and 813 and 108 were included in the according-to-protocol cohorts for humoral and cell-mediated immunity persistence.

For the mTVC, the mean age at first vaccination in ZOE-50/70 was 67.3 years with 60.7% women, and 76.5% of participants were of European ancestry.

“These data suggest that the clinical benefit of the RZV in adults aged ≥50 years is sustained up to 10 years after vaccination, which may reassure practitioners and consequently lead to increased vaccination coverage among those who are recommended to receive RZV,” stated study author Ana Strezova, MD, director, senior clinical research and development lead—Shingrix for Belgium-based GSK.

This 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.

“We are delighted to see the continuing longevity of protection from our shingles vaccine,” added Sabine Luik, chief medical officer and senior vice president for global medical regulatory and quality for GSK. “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 years and over.”

The new data significantly adds to, and complements, the existing body of evidence demonstrating the long-term benefit of the vaccine.

References

1. Ana Strezova, Javier Diez-Domingo, Kamal Al Shawafi, Juan Carlos Tinoco, Meng Shi, Paola Pirrotta, Agnes Mwakingwe-Omari, Zoster-049 Study Group, Long-term protection against herpes zoster by the adjuvanted recombinant zoster vaccine: interim efficacy, immunogenicity, and safety results up to 10 years after initial vaccination. Open Forum Infectious