GSK, UK DRI and HDR UK to explore link between shingles vaccine and reduced dementia risk in real-world data study

GSK has announced a new research collaboration with the UK Dementia Research Institute (UK DRI) and Health Data Research UK (HDR UK) to explore whether a shingles vaccination may be linked to a reduced risk of dementia. The study will use the UK’s national health data infrastructure and is expected to contribute to understanding neurodegenerative conditions through large-scale real-world evidence (RWE).

The project, described as the first of its kind, will focus on GSK’s shingles vaccine (RZV) and its potential association with lower dementia risk. While existing observational and retrospective studies have suggested a possible link, these designs are subject to unmeasured confounding factors and do not allow researchers to confirm a causal relationship.

Tony Wood, Chief Scientific Officer at GSK, noted the opportunity this presents for research in the UK:

“The UK’s national scale health data resources provide a significant opportunity for cutting-edge research. We hope this world-class research collaboration will not only answer key questions to help reduce dementia risk but also pave the way for future data-led research to unravel the underlying causes of complex diseases so we can get ahead of them.”

The study, known as EPI-ZOSTER-110, is a quasi-experimental RWE analysis involving individuals who were aged 65 or 66 at the time of the expansion of the UK Shingles National Immunisation Programme (NIP) in September 2023. Under the phased rollout, those turning 65 became eligible for RZV, while individuals aged 66 will become eligible when they turn 70. This staggered rollout creates a natural randomization, allowing for comparison between vaccinated and unvaccinated groups.

Professor Siddharthan Chandran, Director of UK DRI, highlighted the importance of combining data and scientific expertise:

“Through cross-disciplinary collaboration that combines cutting-edge research capabilities with data at scale, we hope to showcase the potential of UK health data to improve not only our fundamental understanding of dementia but to identify potential interventions that could have a transformational impact.”

The study will use deidentified, population-level electronic health records from the UK’s National Health Service (NHS), covering England, Scotland, Wales, and Northern Ireland. It will analyze data from approximately 1.4 million individuals aged 65 and 66, incorporating information from primary and secondary care, medication records, and mortality data. This comprehensive dataset will allow researchers to assess dementia-related outcomes while accounting for factors such as vaccination status, age, sex, and co-existing medical conditions. Following a feasibility assessment, the data will be securely analyzed over a 4-year period, until the 66-year-old cohort reaches age 70 and becomes eligible for RZV. All data will be accessed within trusted research environments to ensure privacy and security, and GSK’s access will remain limited to the defined scope of the study.

Professor Andrew Morris, Director of HDR UK, explained the broader impact:

“By working closely with the NHS in the four UK nations to ensure data privacy and security, we can enable prevention-focused research, deepen our understanding of disease and support the NHS in shifting from treating sickness to keeping people healthier for longer – helping them live better lives.”

Science Secretary Peter Kyle described the initiative as an example of how collaboration across sectors can support research into dementia, which he called “one of the biggest challenges to health in our time.”