Last updated: 10/16/2024 10:40:08
Study to assess the risk of dementia among older adults in the United States vaccinated with recombinant zoster vaccine (RZV)
GSK study ID
223289
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Trial overview
Official title: An observational study to assess the risk of dementia among older adults in the United States vaccinated with Shingrix
Trial description: The purpose of this observational study is to evaluate the reduction of dementia risk among United States (US) Medicare beneficiaries (>=) 65 years of age or older, who received two doses of recombinant zoster vaccine (RZV) in 2018 through 2020 relative to comparators who had a preventive care visit in 2018 through 2020, but did not receive the RZV.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Hazard ratio of new onset dementia in the 2-dose RZV vaccinated and matched unvaccinated groups
Timeframe: From Day 1 after the index date (RZV Dose 2 date for vaccinated participants and the preventive care visit date for the unvaccinated participants) until the earliest of the outcome of interest or a censoring event
Secondary outcomes:
Hazard ratio of new onset vascular dementia (VD) in the 2-dose RZV vaccinated and matched unvaccinated groups
Timeframe: From Day 1 after the index date (RZV Dose 2 date for vaccinated participants and the preventive care visit date for the unvaccinated participants) until the earliest of the outcome of interest or a censoring event
Hazard ratio of new onset Alzheimer’s Disease (AD) in the 2-dose RZV vaccinated and matched unvaccinated groups
Timeframe: From Day 1 after the index date (RZV Dose 2 date for vaccinated participants and the preventive care visit date for the unvaccinated participants) until the earliest of the outcome of interest or a censoring event
Interventions:
Not applicable
Enrollment:
282821
Primary completion date:
2025-11-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Zoster
Product
Not applicable
Collaborators
University of Maryland Baltimore
Study date(s)
October 2024 to April 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
65+ years
Accepts healthy volunteers
Yes
- US Medicare beneficiaries must meet all the following inclusion criteria to be eligible for inclusion in the study:
- 1. Receipt of two doses of RZV for the exposed or at least one preventive care visit with no prior RZV for the RZV unvaccinated comparator.
- 1. US Medicare beneficiaries who are continuously enrolled only in Medicare Part C in the 365 days (i.e., baseline period) preceding the RZV Dose 2 date for RZV exposed or the preventive care visit date for the RZV unvaccinated comparator.
- 2. Evidence of any dementia (including Lewy Body dementia and age-related cognitive decline), vascular dementia (VD), Alzheimer’s Disease (AD), or Mild Cognitive Impairment (MCI) in the 365 days (i.e., baseline period) preceding the RZV Dose 2 date for RZV exposed and the preventive care visit date for the RZV unvaccinated comparator. The 365-day baseline period will be used to detect any evidence of a diagnosis on any of the claims files or an AD-related medication dispensing in the Part D claims. The Centers for Medicare and Medicaid Services (CMS) Chronic Condition Warehouse (CCW) data provide chronic condition flags for AD and dementia that capture the first ever diagnosis. This variable will be used to further ensure detection of any dementia prior to the index date, i.e., RZV Dose 2 date or the date of the preventive care visit.
Inclusion and exclusion criteria
Inclusion criteria:
- US Medicare beneficiaries must meet all the following inclusion criteria to be eligible for inclusion in the study: 1. Receipt of two doses of RZV for the exposed or at least one preventive care visit with no prior RZV for the RZV unvaccinated comparator. 2. >=65 years of age at the date of the RZV Dose 2 vaccination or preventive care visit for the RZV unvaccinated comparator. 3. Continuously enrolled in fee-for-service Medicare Parts A, B, and D for at least 365 days preceding the date of RZV Dose 2 vaccination or the preventive care visit for the RZV unvaccinated comparator. Continuous enrollment is determined by Medicare enrollment in the month of the RZV Dose 2 vaccination or preventative care visit and enrollment in at least 11 of the 12 preceding months, i.e., allowing a maximum of one calendar month gap in enrollment.
Exclusion criteria:
- 1. US Medicare beneficiaries who are continuously enrolled only in Medicare Part C in the 365 days (i.e., baseline period) preceding the RZV Dose 2 date for RZV exposed or the preventive care visit date for the RZV unvaccinated comparator. 2. Evidence of any dementia (including Lewy Body dementia and age-related cognitive decline), vascular dementia (VD), Alzheimer’s Disease (AD), or Mild Cognitive Impairment (MCI) in the 365 days (i.e., baseline period) preceding the RZV Dose 2 date for RZV exposed and the preventive care visit date for the RZV unvaccinated comparator. The 365-day baseline period will be used to detect any evidence of a diagnosis on any of the claims files or an AD-related medication dispensing in the Part D claims. The Centers for Medicare and Medicaid Services (CMS) Chronic Condition Warehouse (CCW) data provide chronic condition flags for AD and dementia that capture the first ever diagnosis. This variable will be used to further ensure detection of any dementia prior to the index date, i.e., RZV Dose 2 date or the date of the preventive care visit.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Will be recruiting
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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