GSK has 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 Shingrix maintains efficacy against shingles for more than a decade in adults over 50. The data was 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 per cent vaccine efficacy (VE) in adults aged ≥50 cumulatively within the period from year six to year 11 after vaccination (95 per cent CI 73.7–84.6) 82.0 per cent VE in adults ≥50 at year 11 (95 per cent CI 63.0–92.2), showing VE remains high in each year after vaccination 73.1 per cent VE in adults aged ≥70 cumulatively from six to 11 years after vaccination (95 per cent CI 62.9–80.9) showing high VE rates across all age groups.
Dr Rashmi Hegde, Executive VP – Medical Affairs, GSK India, said, “Given that ageing adults are at a higher risk of complications from shingles, we hope that these findings instill confidence in policymakers to include shingles vaccination in public immunisation plans for adults.”
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, with the pain often described as aching, burning, stabbing or shock-like.Following the rash, up to 30 per cent 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 per cent of people with shingles reported missing work for an average of 9.1 days.
About ZOSTER-049
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, withvaccine 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.