NCT07485283Active, not recruitingPhase 4
Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia
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
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 168460 (actual)
- First submitted
- 8 Mar 2026
- Start date
- 28 Apr 2026
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Tor Biering-Sørensen
- Diseases
- Coronary artery disease, Stroke
- NCT number
- NCT07485283
- EU CT number
- 2025-524944-37-00
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 168460
- From 28 Apr 2026 to the primary completion date, 30 Jun 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A prior diagnosis of dementia
- Chronic inflammatory rheumatic disease and concomitant immunosuppressive therapy
- Prior herpes zoster vaccination
Other
- The study has the following exclusion criteria which will be assessed through self-reporting:
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte Coordinator of this site? Confirm its status | Hellerup | Denmark | Unknown status |
| Danske Lægers Vaccinations Service Coordinator of this site? Confirm its status | Søborg | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.