Last updated: 11/06/2026 09:50:18

A Quasi-experimental Study to Evaluate the Potential Causal Effect of Recombinant Zoster Vaccine (RZV) Eligibility on the Incidence of Dementia in the United Kingdom (UK)

GSK study ID
224265
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Quasi-experimental Study to Evaluate the Potential Causal Effect of Recombinant Zoster Vaccine (RZV) Eligibility on the Incidence of Dementia in the United Kingdom
Trial description: The purpose of this quasi-experimental study is to assess the potential causal effect of RZV eligibility on the incidence of dementia in adult individuals in the UK (England, Northern Ireland, Scotland and Wales). RZV eligible and ineligible adults will be followed for a maximum of 5-years since the national immunization program (NIP) implementation until 2028, when the ineligible adults turn 70 years of age (YOA) and become eligible to receive RZV.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Hazard ratio for dementia in RZV eligible adults compared to ineligible adults 63 to 66 YOA on 31 August 2023

Timeframe: From Day 31 after the index date (65th birthday for eligible adults and 01 September 2023 for ineligible adults) up to 5 years until 1 September 2028 (or until ineligible adults reach 70 YOA, whichever occurs first)

Secondary outcomes:

Hazard ratio for dementia in RZV eligible adults compared to ineligible adults 63 to 66 YOA on 31 August 2023, stratified by sex, country and regions within England

Timeframe: From Day 31 after the index date (65th birthday for eligible adults and 01 September 2023 for ineligible adults) up to 5 years until 1 September 2028 (or until ineligible adults reach 70 YOA, whichever occurs first)

Hazard ratio for dementia in RZV vaccinated adults versus RZV unvaccinated adults 63 to 66 YOA on 31 August 2023

Timeframe: From Day 31 after the index date (65th birthday for eligible adults and 01 September 2023 for ineligible adults) up to 5 years until 1 September 2028 (or until ineligible adults reach 70 YOA, whichever occurs first)

Incidence rate (and hazard ratio) of dementia in RZV vaccinated compared to unvaccinated adults who were RZV NIP eligible 63-64 or 70-79 YOA

Timeframe: From index date (Day 31 after adult becomes eligible for RZV on or after 1 September 2023) until end of follow up (earliest of outcome, death, becoming immunocompromised, loss to follow up, Zoster Vaccine Live [ZVL] receipt or end of data availability)

Number of dementia cases prevented per year projected over 10 years

Timeframe: Over 10 years horizon

Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2027-18-06
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Dementia
Product
Not applicable
Collaborators
Health Data Research (HDR) UK, UK Dementia Research Institute (DRI)
Study date(s)
October 2026 to June 2027
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
63 - 79 Years
Accepts healthy volunteers
Yes
  • The criteria listed below define the basic minimum requirements that need to be met to define the potential study population:
  • Have age (or year and week/month of birth) and sex recorded.
  • Individuals who meet any of the following criteria will be excluded from the respective analytical cohorts for both the quasi-experimental regression discontinuity design and the observational cohort study design:
  • Dementia diagnosis or use of dementia related medications during the 2-year baseline (or any time prior to their index date, if it’s possible to use all available data).
Inclusion and exclusion criteria
Inclusion criteria:

    The criteria listed below define the basic minimum requirements that need to be met to define the potential study population:

    • Have age (or year and week/month of birth) and sex recorded.
    • Recorded as alive and living in the UK (England, Scotland, Northern Ireland or Wales) on 1st September 2023 or their 65th birthday, whichever is later.
    • Have local authority area recorded.
    • Have medical records available in the national primary or secondary care dataset when they become age eligible for the study. Of the eligible population, the respective analytical cohorts will include individuals who meet the following inclusion criteria: Quasi-experimental regression discontinuity design (RZV NIP eligible and ineligible adults):
    • Aged 63 to 66 YOA on 31 August 2023 and alive on their index date.
  • Adults who were 63 or 64 YOA on 31 August 2023 will become eligible for RZV on the date of their 65th birthday, on or after 01 September 2023. Their 65th birthday will be their index date.

    • Adults who were 65 or 66 YOA on 31 August 2023 are not eligible for RZV. Their index date will be 01 September 2023. Observational cohort study design (RZV NIP eligible adults):

    • Ages 63 to 64 or 70-79 YOA on 31 August 2023.
  • Adults who were 63 or 64 YOA on 31 August 2023 will become eligible for vaccination on the date of their 65th birthday, on or after 01 September 2023. Their 65th birthday will define the index date.
  • Adults who were 70 to 79 YOA on 31 August 2023 (who have not yet received a Shingles vaccine), are immediately eligible and their index date will be defined as 01 September 2023.
Exclusion criteria:

    Individuals who meet any of the following criteria will be excluded from the respective analytical cohorts for both the quasi-experimental regression discontinuity design and the observational cohort study design:

    • Dementia diagnosis or use of dementia related medications during the 2-year baseline (or any time prior to their index date, if it’s possible to use all available data).
    • Immunocompromised status during the 2-year baseline period:
  • Individuals with primary or acquired immunodeficiency states due to conditions
  • Individuals on immunosuppressive or immunomodulating therapy
  • Individuals with chronic immune mediated inflammatory disease who are receiving or have received immunosuppressive therapy

    • Individuals who have received a short course of high dose steroids (equivalent >40mg prednisolone per day for more than a week) for any reason in the previous month.

    • Receipt of RZV or ZVL during the 2-year baseline (or any time prior to the index date, if it’s possible to use all available data).

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Planned
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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