Study investigating the reduction in risk of incident dementia among adult individuals in England after the vaccination with recombinant zoster vaccine (RZV)
Trial overview
Risk ratio of onset dementia in the 2-dose RZV vaccinated group compared to the matched unvaccinated group among older adults (OA) of eligible age on or after 1 September 2023 [roll-out date for RZV National Immunization Program (NIP) in the UK]
Timeframe: From time zero (eligibility date) until earliest of censoring events [death, de-registration from RSC network, receipt of Zoster vaccine live (ZVL), end of study] or diagnosis of dementia
Risk ratio of onset dementia in the 1-dose RZV vaccinated group compared to the matched unvaccinated group among OA of eligible age on or after 1 September 2023 (roll-out date for RZV NIP in the UK)
Timeframe: From time zero (eligibility date) until earliest of censoring events (death, de-registration from RSC network, receipt of ZVL, end of study) or diagnosis of dementia
Risk ratio of onset dementia in the 1-dose and 2-dose RZV vaccinated groups compared to the matched pneumococcal polysaccharide vaccine (PPSV23) vaccinated group among OA of eligible age on or after 1 September 2023 (roll-out date for RZV NIP in the UK)
Timeframe: From time zero (eligibility date) until earliest of censoring events (death, de-registration from RSC network, receipt of ZVL, end of study) or diagnosis of dementia
Risk ratio of onset mild cognitive impairment (MCI) in the 1-dose and 2-dose RZV vaccinated groups compared to the matched unvaccinated group among OA of eligible age on or after 1 September 2023 (roll-out date for RZV NIP in the UK)
Timeframe: From time zero (eligibility date) until earliest of censoring events (death, de-registration from RSC network, receipt of ZVL, end of study) or diagnosis of MCI
Risk ratio of onset MCI in the 1-dose and 2-dose RZV vaccinated groups compared to the matched PPSV23 vaccinated group among older adults of eligible age on or after 1 September 2023 (roll-out date for RZV NIP in the UK)
Timeframe: From time zero (eligibility date) until earliest of censoring events (death, de-registration from RSC network, receipt of ZVL, end of study) or diagnosis of MCI
Risk ratio of onset dementia in the 1-dose and 2-dose RZV vaccinated groups compared to the matched unvaccinated group among immunocompromised individuals aged 50+ years on or after 1 September 2023 (roll-out date for RZV NIP in the UK)
Timeframe: From time zero (eligibility date) until earliest of censoring events (death, de-registration from RSC network, receipt of ZVL, end of study) or diagnosis of dementia
Risk ratio of onset dementia in the 1-dose and 2-dose RZV vaccinated groups compared to the matched PPSV23 vaccinated group among immunocompromised individuals aged 50+ years on or after 1 September 2023 (roll-out date for RZV NIP in the UK)
Timeframe: From time zero (eligibility date) until earliest of censoring events (death, de-registration from RSC network, receipt of ZVL, end of study) or diagnosis of dementia
Risk ratio of onset MCI in the 1-dose and 2-dose RZV vaccinated groups compared to the matched unvaccinated group among immunocompromised individuals aged 50+ years on or after 1 September 2023 (roll-out date for RZV NIP in the UK)
Timeframe: From time zero (eligibility date) until earliest of censoring events (death, de-registration from RSC network, receipt of ZVL, end of study) or diagnosis of dementia
Risk ratio of onset MCI in the 1-dose and 2-dose RZV vaccinated groups compared to the matched PPSV23 vaccinated group among immunocompromised individuals aged 50+ years on or after 1 September 2023 (roll-out date for RZV NIP in the UK)
Timeframe: From time zero (eligibility date) until earliest of censoring events (death, de-registration from RSC network, receipt of ZVL, end of study) or diagnosis of MCI
Descriptive statistics of the characteristics of OA in the 1-dose and 2-dose RZV vaccinated groups compared to the matched unvaccinated group for the cohorts examining dementia and MCI as outcomes
Timeframe: From time zero (eligibility date) until earliest of censoring events (death, de-registration from RSC network, receipt of ZVL, end of study) or diagnosis of dementia
Descriptive statistics of the characteristics of OA in the 1-dose and 2-dose RZV vaccinated groups compared to the matched PPSV23 vaccinated group for the cohorts examining dementia and MCI as outcomes
Timeframe: From time zero (eligibility date) until earliest of censoring events (death, de-registration from RSC network, receipt of ZVL, end of study) or diagnosis of MCI
Participation criteria
- Older adult cohort:
- The Shingles vaccination programme in the UK consists of two-doses of RZV vaccination, eligibility criteria for the first vaccination are as follows: from 1 September 2023 to 31 August 2028, RZV vaccination will be offered to those adults who are:
- Existing or previous history of dementia prior to cohort entry.
- Any contraindication for vaccination with RZV.
- At least one year of continuous records in the RSC network (No gaps are expected in the medical records even if a patient changes GPs since medical records are transferred to the new GP). Immunocompromised cohort: Immunocompromised individuals are also eligible for the shingles programme, such adults will be offered the first vaccination dose from 50 years of age commencing on 1st September 2023. The second dose will be offered to immunocompromised adults eight weeks to six months after the first. There is no upper age limit to eligibility for this cohort.
- From 1st September 2023 aged ≥50 years of age who meet one of the following criteria (as per UK Green Book [Shingles, 2024]):
- People with primary or acquired immunodeficiency states due to a set list of conditions.
- People on specific 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. In addition, the following criteria will apply upon cohort entry (age eligibility criteria as above met):
- At least one year of continuous records in the RSC network (No gaps are expected in the medical records even if a patient changes GPs since medical records are transferred to the new GP).
Older adult cohort: The Shingles vaccination programme in the UK consists of two-doses of RZV vaccination, eligibility criteria for the first vaccination are as follows: from 1 September 2023 to 31 August 2028, RZV vaccination will be offered to those adults who are: i. Individuals born on or after 1st September 1958 from their 65th birthday. These individuals will remain eligible until their 80th birthday. ii. Individuals who have had their 70th birthday and these individuals will remain eligible until their 80th birthday. The second vaccination dose will be offered six to 12 months after the first, and may therefore occur in the year after their 80th birthday. In addition, the following criteria will apply upon cohort entry (age eligibility criteria as above met):
- Any contraindication for vaccination with RZV.
- A record of RZV (or other Shingles, herpes zoster) vaccination before study start date (i.e. would not be eligible for inclusion). Please note that the number of individuals with a history of herpes zoster vaccination will be evaluated and if found to be high, we will explore alternative options to account for previous zoster vaccine history rather than excluding. This decision will be based on descriptive analysis of the data and occur prior to outcomes assessment.
- A history of allergic disease or reactions to injected vaccinations. For the cohorts in the analysis with MCI as an outcome, additional exclusion criteria apply:
- Existing or previous history of MCI.
Existing or previous history of dementia prior to cohort entry.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.