Actively Recruiting

Phase 4
Age: 65Years +
All Genders
Healthy Volunteers
NCT07485283

Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia

Led by Tor Biering-Sørensen · Updated on 2026-05-04

162000

Participants Needed

2

Research Sites

152 weeks

Total Duration

On this page

Sponsors

T

Tor Biering-Sørensen

Lead Sponsor

G

GlaxoSmithKline

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia

Who Can Participate

Age: 65Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years and above at the time of consent
  • Ability to understand written and spoken Danish or English
  • Signed and dated informed consent form
Not Eligible

You will not qualify if you...

  • Prior diagnosis of dementia
  • Chronic inflammatory rheumatic disease with immunosuppressive therapy
  • Previous herpes zoster vaccination

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Hellerup, Denmark, 2900

Not Yet Recruiting

2

Danske Lægers Vaccinations Service

Søborg, Denmark

Actively Recruiting

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Research Team

D

Daniel Modin, MD

CONTACT

T

Tor Biering-Sørensen, MD, PhD, MSc, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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