Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia

Sponsor
Tor Biering-Sørensen
Study ID
NCT07485283
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cardiovascular Disease
  • Dementia

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Recombinant Herpes Zoster Vaccine (Shingrix) — BIOLOGICAL
    Two doses of Shingrix vaccine spaced 2-6 months apart.

Study Details

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 Dates

First listed
Mar 20, 2026
Start date
Apr 28, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
162,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Recombinant Herpes Zoster Vaccine (Shingrix).
  • No Intervention: No Herpes Zoster vaccine (control)
    Control arm, no intervention.

Primary Outcome Measure

Hospitalization for MACE [ Time Frame: From the first of the two initially booked study visits up to approximately 1 year ]

Central Contacts

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