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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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
First vaccine dose
An intramuscular injection (a shot into the muscle) of the Shingrix vaccine is administered.
The dose consists of 0.5 mg of the active substance recombinant varicella zoster virus glycoprotein e.
Step 2
Second vaccine dose
A second intramuscular injection (a shot into the muscle) of the Shingrix vaccine is administered.
The dose consists of 0.5 mg of the active substance recombinant varicella zoster virus glycoprotein e.

Who can join the trial?

4 criteria

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 trial?

4 criteria

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.

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Gentofte Hospital
Hellerup, Denmark

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Investigated drugs

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.

Recombinant Varicella Zoster Virus Glycoprotein E

What is already known about the treatment

Shingrix - This vaccine is administered as an intramuscular injection using a powder and liquid mixture. It is currently an approved medical treatment used to prevent shingles, also known as herpes zoster. The vaccine works by introducing a specific piece of the virus protein into the body to teach the immune system how to recognize and fight the actual virus. It is classified as a recombinant, adjuvanted vaccine.

Investigated diseases

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.