Cardiovascular DiseasePhase 4DAN-ZOSTERNCT07485283
Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia
A Phase 4 study testing Recombinant Herpes Zoster Vaccine (Shingrix) in people with Cardiovascular Disease and Dementia, run by Tor Biering-Sørensen at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Dementia
- What is being tested?
- Recombinant Herpes Zoster Vaccine (Shingrix)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168,460 participants
- Where
- 2 sitesDenmark
- Study dates
- 28 Apr 2026to Jun 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- The study has the following exclusion criteria which will be assessed through self-reporting:
- A prior diagnosis of dementia
- Chronic inflammatory rheumatic disease and concomitant immunosuppressive therapy
- Prior herpes zoster vaccination
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, 2900
Danske Lægers Vaccinations Service
Søborg
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Herpes zoster is caused by reactivation of the varicella-zoster virus and becomes increasingly common with age. In addition to causing acute illness and postherpetic neuralgia, observational studies have suggested that herpes zoster infection may be associated with an increased risk of cardiovascular events and dementia. Some observational studies have also reported lower risks of these outcomes among individuals vaccinated against herpes zoster. However, these findings may be affected by confounding, and randomized evidence is currently lacking.
The DAN-ZOSTER trial is a nationwide pragmatic randomized clinical trial designed to evaluate whether vaccination with the recombinant herpes zoster vaccine (Shingrix®) reduces the risk of major adverse cardiovascular events (MACE) and incident dementia in older adults.
In this open-label trial, approximately 162,000 adults aged 65 years or older will be randomized in a 1:1 ratio to receive the recombinant herpes zoster vaccine or no intervention. Participants randomized to the intervention arm will receive two intramuscular doses of Shingrix® administered 2-6 months apart. Participants randomized to the control arm will receive no study vaccination.
Outcomes and follow-up data will be obtained through linkage with Danish nationwide health registries.
The trial has two dual-primary outcomes: (1) major adverse cardiovascular events, defined as a composite of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death, and (2) incident dementia, defined as Alzheimer's disease, vascular dementia, or unspecified dementia. The study uses an event-driven design with predefined minimum follow-up requirements for each primary outcome.
- Conditions
- Cardiovascular Disease, Dementia
- Being tested
- Recombinant Herpes Zoster Vaccine (Shingrix)
- Keywords
- herpes zoster, dementia, myocardial infarction, stroke, cardiovascular death, pragmatic, registry, vaccination, herpes zoster vaccine, shingles, randomized trial
- Medical subject headings
- Cardiovascular Diseases, Dementia, Herpes Zoster, Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Herpes Zoster Vaccine (Shingrix)Biological
Two doses of Shingrix vaccine spaced 2-6 months apart.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Herpes Zoster Vaccine (Shingrix). | Experimental | Not described Receives: Biological: Recombinant Herpes Zoster Vaccine (Shingrix) |
| No Herpes Zoster vaccine (control) | No intervention | Control arm, no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization for MACE
Defined as a composite of non-fatal myocardial infarction, non-fatal stroke and cardiovascular death
Measured: 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
Measured: 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
Defined as a composite of acute coronary syndrome, stroke and cardiovascular death
Any I-diagnosis as cause of death
Measured: From the first of the two initially booked study visits up to approximately 1 year
Hospitalization for any cardiovascular disease
Measured: From the first of the two initially booked study visits up to approximately 1 year
Hospitalization for stroke
Measured: From the first of the two initially booked study visits up to approximately 1 year
Hospitalization for myocardial infarction
Measured: From the first of the two initially booked study visits up to approximately 1 year
Cardiovascular death
Measured: From the first of the two initially booked study visits up to approximately 1 year
Inpatient and/or outpatient diagnosis of Alzheimer's dementia
Measured: From the first of the two initially booked study visits up to approximately 3 years
Inpatient and/or outpatient diagnosis of vascular dementia
Measured: From the first of the two initially booked study visits up to approximately 3 years
Inpatient and/or outpatient diagnosis of unspecified dementia
Measured: From the first of the two initially booked study visits up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start28 Apr 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168,460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tor Biering-Sørensen
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor-investigator, Tor Biering-Sørensen, Herlev and Gentofte Hospital
- Investigators
- Tor Biering-Sørensen, MD, PhD, MSc, MPH, Study chair, Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485283
- Sponsor's protocol ID
- DAN-ZOSTER
- Other IDs
- 2025-524944-37-00, 2025
- Acronym
- DAN-ZOSTER
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.