Last updated: 02/21/2024 10:10:13

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

GSK study ID
222419
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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 between matched individuals exposed to SHINGRIX in comparison to those exposed to ZOSTAVAX

Timeframe: Evaluated at 3- and 5-years post-exposure

Relative cumulative hazard between matched individuals exposed to SHINGRIX in comparison to those exposed to Pneumococcal vaccine (PPSV23)

Timeframe: Evaluated at 3- and 5-years post-exposure

Relative cumulative hazard between matched individuals exposed to SHINGRIX in comparison to those not exposed to various vaccinations hypothesized to be associated with dementia (see I/E criteria)

Timeframe: Evaluated at 3- and 5-years post-exposure

Relative cumulative hazard between matched individuals exposed to ZOSTAVAX in comparison to those exposed to PPSV23

Timeframe: Evaluated at 3- and 5-years post-exposure

Relative cumulative hazard between matched individuals exposed to ZOSTAVAX in comparison to those not exposed to various vaccinations hypothesized to be associated with dementia (see I/E criteria)

Timeframe: Evaluated at 3- and 5-years post-exposure

Secondary outcomes:

Relative cumulative hazard between matched individuals diagnosed with Herpes Zoster in comparison to those not diagnosed with Herpes Zoster

Timeframe: Evaluated at 3- and 5-years post-exposure

Relative cumulative hazard between matched individuals diagnosed with Herpes Simplex Virus infection in comparison to those not diagnosed with Herpes Simplex Virus infection

Timeframe: Evaluated at 3- and 5-years post-exposure

Interventions:
Not applicable
Enrollment:
100000000
Primary completion date:
2023-24-10
Observational study model:
Not applicable
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 October 2023
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)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Study complete
Actual primary completion date
2023-24-10
Actual study completion date
2023-24-10

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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