Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia

Recruiting now · Phase 4

Conditions studied: Cardiovascular Disease, Dementia

In brief

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.

Key facts

Study ID

NCT07485283

Run by

Tor Biering-Sørensen

People needed

162000

Starts

2026-04-28

Expected to finish

2029-04-01

Last updated by the study team

2026-05-04

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

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…

• 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

Where it is running

• Danske Lægers Vaccinations Service — Søborg, Denmark (enrolling)
• Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte — Hellerup, Denmark

Full record on ClinicalTrials.gov

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