UK Research Collaborative Will Evaluate GSK Shingles Vaccine Effect on Dementia
GSK is partnering with the UK Dementia Research Institute and Health Data Research UK to further investigate the potential for the RZV vaccine to mitigate cognitive decline.
A unique research collaboration will investigate the potential association between a vaccine against shingles and reduced risk of dementia, according to an announcement from GSK.1
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The company is partnering with the UK Dementia Research Institute (UK DRI) and Health Data Research UK (HDR UK) to further explore early observations that the GSK shot, recombinant zoster vaccine (RZV), is associated with an attenuation of the cognitive decline associated with aging.1
Several retrospective observational studies have generated interest in the potential protective effect of shingles vaccination, but most have compared vaccinated with unvaccinated cohorts, limiting any causal inference.2 A recent study published in Nature Medicine took advantage of the rapid transition from live to recombinant vaccine types after 2017 in the US to compare the risk of dementia between the vaccines. Analyzing data from electronic health records (EHR), the authors reported a significantly lower risk of dementia in those who received the recombinant shot during a 6-year post-vaccination period.2 Specifically they documented a 17% increase in diagnosis-free time, which translated into 164 additional days without a dementia diagnosis in those who were subsequently affected.2
Like the US study, EPI-ZOSTER-110 will leverage the UK’s health data “ecosystem” to assess population-level EHR from the National Health Service (NHS) over 4 years, GSK said. Use of the deidentified NHS EHR data will allow the research partners to mitigate the potential for unmeasured confounders, creating a more robust evidence base. The dataset will include linked primary care, secondary care, medication, and mortality records from all 4 UK nations, according to GSK. Data access will be limited to trusted research environments. Moreover, GSK will not own the study data nor access it beyond the scope of this research, the company stated.
The research will evaluate dementia risk in adults aged 65 and 66 at the time of the expansion of the UK Shingles National Immunisation Programme on September 1, 2023. Under this program, individuals turning age 65 became eligible for RZV, while those aged 66 will become eligible at age 70. Similar to the serendipitous vaccine transition opportunity in the US, the staggered rollout provides a natural randomization allowing researchers to compare dementia incidence between vaccinated and unvaccinated cohorts while accounting for confounding factors such as age, sex, and comorbidities.
“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," GSK chief scientific officer Tony Wood, said in the company statement.
“This is a wonderful example of the private sector working hand-in-hand with the public and third sector, leveraging the power of health data, to drive a greater understanding of how we might reduce the risk of dementia," Peter Kyle, UK Science Secretary added.
RZV, a recombinant subunit vaccine for shingles prevention, approved for adults aged 50 and older in the US, consists of glycoprotein E combined with the AS01B adjuvant system. The vaccine is approved for individuals at increased risk for shingles in multiple other countries and its potential broader impact on neurodegenerative disease risk remains an area of active investigation.
