Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia
DAN-ZOSTER
A Pragmatic Randomized Trial to Evaluate the Effect of Recombinant Herpes Zoster Vaccine on Major Adverse Cardiovascular Events and Dementia in Adults Aged 65 Years or Above
2 other identifiers
interventional
162,000
1 country
2
Brief Summary
DAN-ZOSTER is a nationwide randomized study investigating whether vaccination against herpes zoster (shingles) can reduce the risk of cardiovascular disease and dementia in older adults. Herpes zoster is caused by reactivation of the varicella-zoster virus and becomes more common with increasing age. Some observational studies have suggested that vaccination against herpes zoster may also lower the risk of heart attacks, strokes, and dementia, but this has not been confirmed in randomized clinical trials. In this study, approximately 162,000 adults aged 65 years or older living in Denmark will be randomly assigned to either receive the recombinant herpes zoster vaccine (Shingrix®) or receive no vaccine. Participants in the vaccine group will receive two doses given 2-6 months apart. Participants will be identified and invited using Danish national registries and digital mail systems. Information about health outcomes will be collected through nationwide health registries during follow-up. The main outcomes of the study are major cardiovascular events (heart attack, stroke, or cardiovascular death) and new diagnoses of dementia. The goal of the study is to determine whether herpes zoster vaccination can help prevent these conditions in older adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2026
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2026
CompletedFirst Posted
Study publicly available on registry
March 20, 2026
CompletedStudy Start
First participant enrolled
April 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
May 4, 2026
April 1, 2026
2.9 years
March 8, 2026
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Hospitalization for MACE
Defined as a composite of non-fatal myocardial infarction, non-fatal stroke and cardiovascular death
From the first of the two initially booked study visits up to approximately 1 year
New dementia
Defined as a composite of Alzheimer's dementia, vascular dementia and unspecified dementia
From the first of the two initially booked study visits up to approximately 3 years
Secondary Outcomes (8)
Hospitalization for non-fatal acute coronary syndrome, non-fatal stroke, or cardiovascular death
From the first of the two initially booked study visits up to approximately 1 year
Hospitalization for any cardiovascular disease
From the first of the two initially booked study visits up to approximately 1 year
Hospitalization for stroke
From the first of the two initially booked study visits up to approximately 1 year
Hospitalization for myocardial infarction
From the first of the two initially booked study visits up to approximately 1 year
Cardiovascular death
From the first of the two initially booked study visits up to approximately 1 year
- +3 more secondary outcomes
Other Outcomes (26)
Hospitalization for unstable angina
From the first of the two initially booked study visits up to approximately 3 years
Acute and/or elective coronary revascularization
From the first of the two initially booked study visits up to approximately 3 years
Hospitalization for heart failure
From the first of the two initially booked study visits up to approximately 3 years
- +23 more other outcomes
Study Arms (2)
Recombinant Herpes Zoster Vaccine (Shingrix).
EXPERIMENTALNo Herpes Zoster vaccine (control)
NO INTERVENTIONControl arm, no intervention.
Interventions
Two doses of Shingrix vaccine spaced 2-6 months apart.
Eligibility Criteria
You may qualify if:
- Age 65 years and above at the time of consent
- Self-reported ability to understand written and spoken Danish or English
- Informed consent form has been signed and dated
You may not qualify if:
- A prior diagnosis of dementia
- Chronic inflammatory rheumatic disease and concomitant immunosuppressive therapy
- Prior herpes zoster vaccination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tor Biering-Sørensenlead
- GlaxoSmithKlinecollaborator
Study Sites (2)
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, 2900, Denmark
Danske Lægers Vaccinations Service
Søborg, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tor Biering-Sørensen, MD, PhD, MSc, MPH
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 8, 2026
First Posted
March 20, 2026
Study Start
April 28, 2026
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
In this trial, baseline and endpoint data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.