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Results from the ZOSTER-122 retrospective, observational matched-cohort study in adults aged 50 years and over, examines the potential association between Shingrix (Recombinant Zoster Vaccine or RZV) vaccination and reduced risk of dementia

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Published:6th Aug 2024

GSK presented results at the Alzheimer's Association International conference from the ZOSTER-122 retrospective, observational matched-cohort study in adults aged 50 years and over, which examines the potential association between Shingrix (Recombinant Zoster Vaccine or RZV) vaccination and reduced risk of dementia compared to two other vaccines

GSK’s abstract was presented alongside five other abstracts in a Featured Research Session on shingles and dementia risk.

Tony Wood, Chief Scientific Officer, said: “The ZOSTER-122 retrospective study adds to the growing body of evidence that suggests an association between shingles vaccination and reduced risk of dementia. These are compelling early results, which we are investigating further with additional retrospective and mechanistic studies to advance the field.”

Headline data show vaccination with either RZV or Zostavax (Zoster Vaccine Live or ZVL) was associated with statistically significant reductions in dementia risk compared to a control cohort vaccinated with Pneumovax 23 (PPSV23), another elective adult vaccine recommended for similar age groups: i. At three years: RZV was associated with a 24% reduced risk of dementia compared to PPSV23, and ZVL was associated with a 14% reduced risk compared to PPSV23. ii. At five years: RZV was associated with a 20% reduced risk of dementia compared to PPSV23, and ZVL was associated with an 8% reduced risk compared to PPSV23.

The study also shows that RZV was associated with statistically significant reductions in dementia risk compared to ZVL: At three years: RZV was associated with a 27% reduced risk of dementia compared to ZVL. At five years: RZV was associated with a 23% reduced risk of dementia compared to ZVL.

About ZOSTER-122: ZOSTER-122 is an observational, retrospective matched-cohort study of adults aged 50 years and over, initiated to explore whether RZV vaccination is associated with a reduced risk of dementia, in line with previous studies demonstrating this association with ZVL vaccination. ZOSTER-122 utilised the Optum de-identified Electronic Health Record (Optum EHR) data set, which covers over 115 million lives, 2000 hospitals and 5000 clinics in the United States healthcare system. The study utilised de-identified records collected in the period between 1 October 2007 to 30 September 2023 and grouped cohorts defined by vaccine exposure who were recorded to have received the RZV, ZVL and/or PPSV23 vaccinations. A machine-learning model was used to match individuals across 394 covariates captured in the health database, helping to control for dementia-associated risks like blood pressure, smoking status, preventive health service uptake and healthcare utilisation, therefore minimising the potential for “healthy vaccinee bias” across cohorts. A limitation of many retrospective observational studies, including ZOSTER-122, is that they may be affected by unmeasured confounding and therefore cannot establish causality.

No studies to date have demonstrated a causal association between RZV vaccination and reduced risk of dementia, and RZV is not approved by any regulatory authority for the prevention of dementia.

Condition: Herpes Zoster (Shingles)
Type: drug

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