Shingrix Demonstrates 82% Efficacy Against Shingles 11 Years Post-Vaccination in Long-Term Phase III ZOSTER-049 Trial

Apr 18, 2024 07:49 CST Updated 07:49

GSK

Pharmaceutical R&D Manufacturer

▎Edited by the WuXi AppTec content team

GSK announced today that its recombinant zoster vaccine Shingrix (RZV) has obtained positive data in the long-term follow-up Phase 3 clinical trial ZOSTER-049. This trial tracked participants for up to approximately 11 years after receiving Shingrix. The final data showed,RZV provides over ten years of protection against shingles for adults aged 50 and above.

The main results of ZOSTER-049 include:

The cumulative vaccine effectiveness (VE) in adults aged 50 years and older was 79.7% (95% CI, 73.7-84.6) from year 6 to year 11 after vaccination.
At year 11, vaccine efficacy in adults aged 50 years and older was 82.0% (95% CI, 63.0–92.2), demonstrating sustained high efficacy annually post-vaccination.
From year 6 to year 11 post-vaccination, the cumulative vaccine effectiveness among adults aged 70 years and older was 73.1% (95% CI, 62.9-80.9), demonstrating high effectiveness across all age groups.

During the follow-up period of ZOSTER-049, no new safety issues were identified. No serious adverse events were considered by the investigators to be causally related to RZV vaccination. In adults aged 50 years and older, the most commonly reported adverse reactions to RZV were injection site pain, myalgia, fatigue, and headache. These reactions were mostly mild to moderate and generally resolved within three days.

Herpes zoster is caused by the reactivation of the varicella-zoster virus (VZV), which is also the pathogen responsible for chickenpox. Most adults already carry this virus, and it may reactivate with age. Globally, herpes zoster will affect up to one-third of the population. Factors that increase the risk of developing herpes zoster include aging, immunodeficiency or immunosuppression, and other chronic conditions (such as chronic obstructive pulmonary disease, diabetes, and asthma).

Shingrix is a non-live, recombinant protein subunit vaccine used to prevent shingles in adults aged 50 and older.It combines the antigen, glycoprotein E, with the adjuvant system AS01B, which helps overcome age-related immune response decline—a crucial factor for protecting adults aged 50 and above from shingles outbreaks.

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References:

[1] New long-term data show Shingrix continues to provide high protection against shingles in adults aged 50 and over for more than a decade. Retrieved April 17, 2024, from https://www.gsk.com/en-gb/media/press-releases/new-long-term-data-show-shingrix-continues-to-provide-high-protection-against-shingles-in-adults-aged-50-and-over-for-more-than-a-decade/

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