NCT07485283 Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia
| NCT ID | NCT07485283 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Tor Biering-Sørensen |
| Condition | Cardiovascular Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 162,000 participants |
| Start Date | 2026-04-28 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 162,000 participants in total. It began in 2026-04-28 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 65 years and above at the time of consent 2. Self-reported ability to understand written and spoken Danish or English 3. Informed consent form has been signed and dated Exclusion Criteria: The study has the following exclusion criteria which will be assessed through self-reporting: 1. A prior diagnosis of dementia 2. Chronic inflammatory rheumatic disease and concomitant immunosuppressive therapy 3. Prior herpes zoster vaccination
Contact & Investigator
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
Frequently Asked Questions
Who can join the NCT07485283 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Cardiovascular Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07485283 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07485283 currently recruiting?
Yes, NCT07485283 is actively recruiting participants. Contact the research team at danielmodin.md@gmail.com for enrollment information.
Where is the NCT07485283 trial being conducted?
This trial is being conducted at Hellerup, Denmark, Søborg, Denmark.
Who is sponsoring the NCT07485283 clinical trial?
NCT07485283 is sponsored by Tor Biering-Sørensen. The principal investigator is Tor Biering-Sørensen, MD, PhD, MSc, MPH at Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte. The trial plans to enroll 162,000 participants.