Herpes Zoster
Conditions
Keywords
Recombinant Zoster Vaccine, Shingrix, Herpes Zoster, Incident dementia, Alzheimer's Disease, Older adults, Finland
Brief summary
The purpose of this study is to evaluate the effect of the recombinant zoster vaccine on the risk of new diagnosis of dementia among adults aged 76 years or older in Finland. Participants will be enrolled and randomized in a 3:1 ratio to receive either recombinant zoster vaccine or placebo.
Interventions
BIOLOGICALRecombinant zoster vaccine
Recombinant zoster vaccine administered intramuscularly, one dose at Visit 1 (Day 1) and one dose at Visit 2 (between 2 and 6 months after the first dose), according to the approved recombinant zoster vaccine dosing schedule.
DRUGPlacebo
Placebo administered intramuscularly, one dose at Visit 1 (Day 1) and one dose at Visit 2 (between 2 and 6 months after the first dose).
Sponsors
GlaxoSmithKline
Finnish Vaccine Research;
Dr Arto Palmu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Data will be collected in an observer-blinded fashion.
Eligibility
Sex/Gender
ALL
Age
76 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Citizens living permanently in Finland, who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure. Informed consent will include consent to access health register data for participants. * Age 76 years or older at the time of signing the informed consent.
Exclusion criteria
* Prior receipt of a Herpes Zoster (HZ) vaccine. * History of dementia diagnosis prior to enrolment, including confirmed cases or those under investigation. This includes: * History of a confirmed clinical diagnosis of dementia prior to enrolment. * Prior or current use of medications intended to treat dementia. * Current or recent history of cognitive assessments for any memory deficit or suspected dementia before enrolment including investigations that are ongoing or that were inconclusive (but not those for which dementia was conclusively ruled out); mild cognitive impairment on its own without any other information to indicate cognitive decline or dementia will not result in exclusion. * Severely immunocompromised individuals. * Concurrently participating in another clinical trial, in which the participant has been or will be exposed to an investigational product or ongoing participation in trials focused on preventive dementia interventions. * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances. * Living in a nursing facility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hazard ratio of incident dementia diagnosis | From first dose of study intervention (Day 1) until the date of first dementia diagnosis, death, loss to follow-up, or end of data availability, whichever occurs first, assessed up to 10 years | Dementia diagnosis is defined as the first-time diagnosis of dementia as identified during the follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hazard ratio of incident dementia diagnosis | From 1 month after second dose of study intervention (2 to 6 months after first dose of study intervention) until the date of first dementia diagnosis, death, loss to follow-up, or end of data availability, whichever occurs first, assessed up to 10 years | Dementia diagnosis is defined as the first-time diagnosis of dementia as identified during the follow-up period. |
| Hazard ratio of incident Alzheimer's disease diagnosis | From first dose of study intervention (Day 1) until the date of first Alzheimer's disease diagnosis, death, loss to follow-up, or end of data availability, whichever occurs first, assessed up to 10 years | Alzheimer's disease diagnosis is defined as the first-time diagnosis of Alzheimer's disease as identified during the follow-up period. |
Countries
Finland
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
Outcome results
None listed