Shingles vaccine (Shingrix) to reduce heart attacks, strokes, 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

This study will test whether two doses of the Shingrix shingles vaccine can lower the risk of major heart events and dementia in people aged 65 and older in Denmark.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 162000 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Herlev and Gentofte Hospital (other)
• Locations: 2 sites (Hellerup and 1 other locations)
• Trial ID: NCT07485283 on ClinicalTrials.gov

What this trial studies

DAN-ZOSTER is a nationwide, open-label randomized trial that will enroll about 162,000 Danish adults aged 65 years or older and randomize them 1:1 to receive two doses of the recombinant herpes zoster vaccine (Shingrix) or no vaccine. The vaccine doses are given 2–6 months apart for those randomized to the intervention arm, while the control arm receives no study vaccination. The trial uses linkage to Danish national health registries to collect outcomes and follow participants for major adverse cardiovascular events and incident dementia. The design is pragmatic, aiming to test the vaccine’s effect on real-world rates of heart attack, stroke, cardiovascular death, and new dementia diagnoses.

Who should consider this trial

Good fit: Ideal candidates are adults aged 65 years or older living in Denmark who can consent, do not have a prior dementia diagnosis, are not already vaccinated against shingles, and are not on chronic immunosuppressive therapy for inflammatory rheumatic disease.

Not a fit: People with existing dementia, those already vaccinated against herpes zoster, and individuals requiring immunosuppressive therapy for chronic inflammatory rheumatic disease are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, vaccination could lower rates of major cardiovascular events and new cases of dementia among older adults.

How similar studies have performed: Observational studies have suggested lower cardiovascular and dementia risks after shingles vaccination, but randomized trials testing this question have not previously confirmed those findings.

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

Where this trial is running

Hellerup and 1 other locations

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

Study contacts

• Study coordinator: Daniel Modin, MD

Conditions: Cardiovascular Disease, Dementia, herpes zoster, dementia, myocardial infarction, stroke, cardiovascular death, pragmatic