GSK plc announced positive data from the ZOSTER-049 long-term follow-up phase III trial which followed participants for up to approximately 11 years following initial vaccination with Shingrix (Recombinant Zoster Vaccine or RZV). The final trial data demonstrate that RZV maintains efficacy against shingles for more than a decade in adults over 50. The data will be presented at ESCMID Global (European Society of Clinical Microbiology and Infectious Diseases) 2024, formerly known as ECCMID in Barcelona, Spain (27-30 April 2024).

The results from ZOSTER-049, an extension from two phase III clinical trials in adults aged 50 and over (ZOE-50 and ZOE-70), include: 79.7% vaccine efficacy (VE) in adults aged =50 cumulatively within the period from year six to year 11 after vaccination (95% CI 73.7-84.6), 82.0% VE in adults =50 at year 11 (95% CI 63.0-92.2), showing VE remains high in each year after vaccination, 73.1% VE in adults aged =70 cumulatively from six to 11 years after vaccination (95% CI 62.9-80.9) showing high VE rates across all age groups. Globally, shingles will affect up to 1 in 3 people in their lifetimes. A variety of factors can increase the risk of developing shingles, including advancing age and immunodeficiency or immunosuppression, as well as other chronic conditions such as COPD, diabetes mellitus, and asthma.

Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face,[8] with the pain often described as aching, burning, stabbing or shock-like.2 Following the rash, up to 30% of people experience post-herpetic neuralgia (PHN), a long-lasting nerve pain that can last weeks or months and can occasionally persist for several years. Shingles is also associated with significant healthcare and human cost, with 57% of people with shingles reported missing work for an average of 9.1 days. ZOSTER-049 is a phase III open-label, long-term follow-up trial from two pivotal phase III randomised clinical trials (ZOE-50, ZOE-70).

The trial evaluated the efficacy, safety, and immunogenicity in adults 50 years and over at time of vaccination, for six additional years after completion of the ZOE-50 and ZOE-70 trials, up to approximately 11 years of follow-up. ZOSTER-049 included over 7,000 participants from 18 countries across five continents, with vaccine recipients compared to historical controls. No new safety concerns were identified during the follow-up period in ZOSTER-049.

No serious adverse events were considered causally related to RZV vaccination by the investigators. In adults aged 50 years and over, the most frequently reported adverse reactions with RZV are pain at the injection site, myalgia, fatigue and headache. Most of these reactions were mild to moderate in intensity and generally lasted less than three days.