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Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia

NCT07485283 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 162000

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Recombinant Herpes Zoster Vaccine (Shingrix)

Two doses of Shingrix vaccine spaced 2-6 months apart.

Sponsors & Collaborators

Principal Investigators

  • Tor Biering-Sørensen, MD, PhD, MSc, MPH · Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-28
Primary Completion
2029-04-30
Completion
2029-04-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07485283 on ClinicalTrials.gov