Evaluating the effect of recombinant varicella zoster virus glycoprotein E vaccine on heart problems and dementia in adults aged 65 years or older with herpes zoster

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What is this study about?

This study examines the effects of the Shingrix vaccine on people aged 65 years or older. The research focuses on Herpes Zoster, a condition commonly known as shingles, which is caused by the same virus that causes chickenpox. The goal of the study is to determine if this vaccine can reduce the risk of certain serious health issues, specifically Major Adverse Cardiovascular Events and Dementia.

Major Adverse Cardiovascular Events refers to serious heart-related problems, such as a myocardial infarction, which is a heart attack, a stroke, or death caused by heart issues. Dementia describes a group of symptoms involving a decline in memory, thinking, and reasoning skills, including conditions like Alzheimer’s dementia or Vascular dementia. The vaccine is administered through an intramuscular injection, which is a shot given directly into a muscle.

Participants in this trial may receive the vaccine or a placebo. The study will follow individuals over a period of time to observe any changes in heart health or cognitive abilities related to the use of the vaccine.

Who Can Join the Study?

You must be 65 years of age or older at the time you agree to join the study.
You must sign and date a document called an informed consent form, which is a paper that explains all the details of the study before you agree to participate.
You must be able to understand written and spoken Danish or English.
Participants should be healthy volunteers, meaning people who do not have significant underlying health problems.

Who Cannot Join the Study?

You have already been diagnosed with dementia, which is a condition that affects memory, thinking, and reasoning skills.
You have a chronic inflammatory rheumatic disease, which is a long-term condition where the body’s immune system attacks its own joints or tissues, causing swelling and pain.
You are currently taking immunosuppressive therapy, which is a type of medicine used to lower or weaken the body’s immune system.
You have previously received a herpes zoster vaccination, which is a vaccine given to prevent shingles.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Gentofte Hospital	Hellerup	Denmark
Dfpmdz Ldnokdx Vrfjqrdgrczm Sijwoyc	Soeborg	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.03.2026

Trial locations

Investigated drugs:

Recombinant Varicella Zoster Virus Glycoprotein E

Shingrix is a vaccine used to help prevent shingles, which is a painful skin rash caused by the same virus that causes chickenpox. In this study, the vaccine is being tested to see if it can also help reduce the risk of serious heart problems and dementia in older adults.

Investigated diseases:

Herpes zoster

Herpes Zoster – This condition is caused by the reactivation of the varicella-zoster virus, which remains dormant in the body after a person has had chickenpox. It typically presents as a painful, blistering skin rash that often follows a specific nerve pattern on one side of the body. The illness can progress from early sensations like tingling or itching to the appearance of red patches and fluid-filled blisters. As the condition develops, the blisters may eventually break open and form crusts. The discomfort associated with the rash can vary in intensity and may persist for several weeks.

Trial ID:

2025-524944-37-00

Protocol code:

DAN-ZOSTER

Trial Phase:

Therapeutic confirmatory (Phase III)

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Evaluating the effect of recombinant varicella zoster virus glycoprotein E vaccine on heart problems and dementia in adults aged 65 years or older with herpes zoster

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?