Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• Hospitalization for MACE — From the first of the two initially booked study visits up to approximately 1 year
  Defined as a composite of non-fatal myocardial infarction, non-fatal stroke and cardiovascular death
• New dementia — From the first of the two initially booked study visits up to approximately 3 years
  Defined as a composite of Alzheimer's dementia, vascular dementia and unspecified dementia

Trial sites (2)

More Tor Biering-Sørensen trials in Denmark

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