Reduction in risk of incident dementia after Shingrix vaccination
Research type
Research Study
Full title
Investigating the reduction in risk of incident dementia after Shingrix vaccination: A target trial emulation using English primary care sentinel network database
IRAS ID
351667
Contact name
Simon de Lusignan
Contact email
Sponsor organisation
Glaxosmithkline
Duration of Study in the UK
2 years, 0 months, 9 days
Research summary
We propose a retrospective cohort study based on the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network database. RSC data are held on the Oxford-RCGP Clinical Informatics Digital Hub (ORCHID) trusted research environment (TRE) hosted by the University of Oxford.
The RSC has a pseudonymised data extract from 32% of the UK population (>19 million people). We will link the RSC’s primary care data to hospital diagnosis and hospital admissions data (HES), and death certificate data (Office of National Statistics (ONS)).
We will include people aged 65 years or above on or after 1st September 2023 and we propose to follow up patients over three years, through to September 2026. The primary outcome of interest will be incidence of dementia. We will identify Shingrix vaccinated individuals as exposed individuals and we will estimate incidence proportions (absolute risk) and relative risk of incidence of dementia based upon two comparisons
a.Shingrix vaccinated individuals and non-vaccinated individuals
b.Shingrix vaccinated individuals and individuals vaccinated with a vaccine that has not been found to be associated with reduced risk of dementia (pneumococcus).
We also propose to study immunocompromised individuals as a subgroup.
Using a trial emulation methodology, incorporating inverse probability of treatment and censoring weighting we will:
1.Estimate incidence of dementia in the cohort stratified by vaccination status
2.Estimate adjusted relative rate ratios of incidence of dementia in two comparisons: vaccinated with Shingrix vaccination versus those individuals with no such vaccination and vaccinated with Shingrix vaccination versus those with a vaccine that has not been found to be associated with reduced risk of dementia (i.e., pneumococcus).
3.Perform a subgroup analysis on immunocompromised individuals
4.Use Mild Cognitive Impairment (MCI) as a secondary outcome and repeat the main analysis using MCI as an outcome.REC name
East Midlands - Derby Research Ethics Committee
REC reference
25/EM/0078
Date of REC Opinion
24 Mar 2025
REC opinion
Favourable Opinion