GSK has announced positive long-term phase 3 results for its shingles vaccine, Shingrix, in adults aged 50 years and above following initial vaccination over a decade prior.
The results from the ZOSTER-049 follow-up trial – an extension from two phase 3 clinical trials – will be presented at the European Society of Clinical Microbiology and Infectious Disease 2024 between 27 and 30 April.
Affecting up to one in three people globally in their lifetimes with long-lasting pain and other complications, shingles or recombinant zoster vaccine (RSV) is an infectious condition that results from the reactivation of the varicella-zoster virus, which causes chickenpox.
The ZOSTER-049 trial evaluated the efficacy, safety and immunogenicity of over 7,000 adults from 18 countries, aged 50 years and over at the time of vaccination, for six additional years after the completion of the phase 3 ZOE-50 and ZOE-70 trials, up to approximately 11 years of follow-up.
The end-of-trial data demonstrated that Shingrix had a 79.7% efficacy against shingles in adults aged 50 years and over, between six and 11 years after vaccination and 82% efficacy at year 11 after initial vaccination, with no new safety concerns identified during the follow-up period.
The company will continue to evaluate the efficacy, immunogenicity and safety of Shingrix across indicated populations, including those at highest risk of infection, to assess the potential need for re-vaccination in future.
Phil Dormitzer, senior vice president, head of vaccines research and development, commented: “This data adds to the body of evidence on the extended long-term protection against shingles and provides further confidence to inform public immunisation strategies.”
Shingrix is already approved in countries including the US, EU and UK to help prevent shingles in people aged 50 years or older and, in some countries, it is also indicated for adults aged 18 years or older who are at increased risk for shingles.
In December 2023, GSK revealed new data from an online global survey, the Shingles Misconception Survey, which revealed a large portion of adults do not understand how shingles may be triggered among adults aged 50 and over, who are most at risk of the disease.