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Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia

Study acronym: DAN-ZOSTER
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 32 days later Apr 2029 → Jun 2029
See other at-risk trials from Tor Biering-Sørensen

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing Show 5 more changesShow less
    • Primary and study completion pushed from Apr 2029 to Jun 2029
    • Enrollment target: estimated 162000 to confirmed 168460
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 4 of 8 entries
    • Site details revised at 2 of 2 sites
  2. Recruitment opened
    • Start date changed from estimate of Apr 2026 to Apr 28, 2026
    • Site details revised at 2 of 2 sites
    v3
  3. Primary and study completion pushed from Mar 2029 to Apr 2029
    • Start date: Mar 2026 to Apr 2026
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Tor Biering-Sørensen
13 trials monitored
See 2 trials at risk
Heart Disease
8,786 trials monitored
See 412 trials at risk
Stroke
3,531 trials monitored
See 153 trials at risk
Dementia
1,978 trials monitored
See 106 trials at risk
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.
Trial Details
NCT Number NCT07485283
Lead Sponsor Tor Biering-Sørensen
Collaborators: GlaxoSmithKline
Conditions
(from sponsor)		 Cardiovascular Disease, Dementia
Related terms Cardiovascular Diseases, Dementia, Herpes Zoster, Myocardial Infarction, Stroke
Enrollment 168,460 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov