Last updated: 07/31/2026 16:50:33

A study on the association between herpes zoster (HZ) vaccination and dementia and mild cognitive impairment using electronic health records

GSK study ID
222419
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: ​​​A retrospective matched cohort study on the association between herpes zoster vaccination and dementia and mild cognitive impairment using electronic health records​​
Trial description: The purpose of this study is to determine if there is an association between either or both Zostavax and Shingrix and dementia or mild cognitive impairment using the large scale, United States (US) electronic health record (EHR) database. This study has not been classified as a Post Authorization Safety Study by the sponsoring organization.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Relative cumulative hazard of dementia between matched individuals exposed to RZV in comparison to those exposed to ZVL [positive control]

Timeframe: At 3 and 5 years post-exposure

Relative cumulative hazard of dementia between matched individuals exposed to RZV in comparison to those exposed to PPSV23 [control with different mechanism]

Timeframe: At 3 and 5 years post-exposure

Relative cumulative hazard of dementia between matched individuals exposed to RZV in comparison to those not exposed to HZ vaccines (RZV and ZVL) [inactive control]

Timeframe: At 3 and 5 years post-exposure

Relative cumulative hazard of dementia between matched individuals exposed to ZVL in comparison to those exposed to PPSV23 [control with different mechanism]

Timeframe: At 3 and 5 years post-exposure

Relative cumulative hazard of dementia between matched individuals exposed to ZVL in comparison to those not exposed to HZ vaccines (RZV and ZVL) [inactive control]

Timeframe: At 3 and 5 years post-exposure

Relative cumulative hazard of dementia between matched individuals exposed to multiple (more than one) HZ episodes in comparison to those exposed to only a single HZ episode [post-hoc MoA-elucidating analysis]

Timeframe: At 3, 6 and 9 years post-exposure

Correlation between the evolution of relative risk of HZ and dementia over time in those exposed to ZVL compared to a PPSV23-exposed control cohort [post-hoc MoA-elucidating analysis]

Timeframe: Over the span of 15 years

Relative cumulative hazard of dementia between matched individuals exposed to systemic antiviral treatment in connection with the first episode of HZ in comparison to those not exposed to antiviral treatment or exposed only to topical antiviral treatments [post-hoc MoA-elucidating analysis]

Timeframe: At 3 and 5 years post-exposure

Relative cumulative hazard of dementia between matched individuals with high use of systemic corticosteroids (>10 prescriptions within one year and after asthma diagnosis) in comparison to those with only low use of corticosteroids (<5 prescriptions after asthma diagnosis) [post-hoc MoA-elucidating analysis]

Timeframe: At 3 and 5 years post-exposure

Relative cumulative hazard of HZ between matched individuals with high use of systemic corticosteroids (>10 prescriptions within one year and after asthma diagnosis) in comparison to those with only low use of corticosteroids (<5 prescriptions after asthma diagnosis) [post-hoc MoA-elucidating analysis]

Timeframe: At 3 and 5 years post-exposure

Secondary outcomes:

Relative cumulative hazard of MCI between matched individuals exposed to RZV in comparison to those exposed to ZVL [positive control]

Timeframe: At 3 and 5 years post-exposure

Relative cumulative hazard of MCI between matched individuals exposed to RZV in comparison to those exposed to PPSV23 [positive control]

Timeframe: At 3 and 5 years post-exposure

Relative cumulative hazard of MCI between matched individuals exposed to RZV in comparison to those not exposed to Herpes Zoster (HZ) vaccines (RZV and ZVL) [inactive control]

Timeframe: At 3 and 5 years post-exposure

Relative cumulative hazard of MCI between matched individuals exposed to ZVL in comparison to those exposed to PPSV23 [control with different mechanism]

Timeframe: At 3 and 5 years post-exposure

Relative cumulative hazard of MCI between matched individuals exposed to ZVL in comparison to those not exposed to HZ vaccines (RZV and ZVL) [inactive control]

Timeframe: At 3 and 5 years post-exposure

Interventions:
Not applicable
Enrollment:
Not applicable
Observational study model:
Cohort
Primary completion date:
2025-31-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Zoster, Memory Disorders
Product
Not applicable
Collaborators
Stanford University
Study date(s)
October 2023 to July 2025
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
Yes
  • Electronic health records available in the Optum EMR.
  • Age at exposure >= 50.
  • Birth year unknown. [data consistency]
  • Marked as deceased but no date of death recorded. [data consistency]
Inclusion and exclusion criteria
Inclusion criteria:

    Electronic health records available in the Optum EMR.

    • Age at exposure >= 50.
    • For SHINGRIX, SHINGRIX-2D (2 doses), ZOSTAVAX, PPSV23: Recorded exposure.
    • For Not Exposed: Visit(s) within +/- 3 months of the exposure date of the matched individual.
Exclusion criteria:

    Birth year unknown. [data consistency]

    • Marked as deceased but no date of death recorded. [data consistency]
    • Exposure date before recorded date of birth. [data consistency]
    • Exposure date after recorded date of death. [data consistency]
    • Exposure date before 1st October 2007 [9-month buffer from EMR records start]
    • Recorded outcome prior to exposure date.
    • For Not Exposed: Not exposed to the comparison group’s exposure.
    • For Not Exposed compared to SHINGRIX or ZOSTAVAX: Not exposed to either ZOSTAVAX, SHINGRIX, PPSV23, influenza, Calmette Guerin or Tdap vaccinations.
    • For active comparators: Also exposed to the exposure of the comparison group. [unique exposure]
    • For MCI outcome: Recorded Dementia outcome prior to exposure date. [temporal consistency; MCI is precursor]
    • For SHINGRIX, SHINGRIX-2D, ZOSTAVAX, PPSV23: Immunization date prior to approval date of vaccine agent (SHINGRIX: 11/2017, ZOSTAVAX: 2006, PPSV23: 1983). [data consistency]
    • For SHINGRIX, SHINGRIX-2D, ZOSTAVAX, PPSV23: More than 3 doses reported. [data consistency]
    • For SHINGRIX, SHINGRIX-2D, ZOSTAVAX, PPSV23: Missing immunization date. [data consistency]

Trial location(s)

No location data available.

Study documents

Protocol
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
2025-31-07
Actual study completion date
2025-31-07

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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