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Evaluating the effect of recombinant varicella zoster virus glycoprotein E on the risk of dementia in adults aged 76 years and older

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study is designed to evaluate the effect of the Shingrix vaccine on the risk of developing dementia, a condition that affects memory, thinking, and reasoning skills. The research focuses on whether receiving this vaccine, which is used to prevent Herpes zoster, also helps in preventing a new diagnosis of this brain-related condition in older adults.

Participants in the study will be assigned to receive either the Shingrix vaccine or a placebo. The Shingrix is a recombinant vaccine, which means it is made using a specific piece of the virus to help the body build protection. The placebo used in this trial is a saline solution, which is a simple mixture of salt and water. The medication will be given as an intramuscular injection, meaning it is delivered directly into the muscle.

The research process

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

  1. Step 1

    First dose administration

    You will receive a single injection into the muscle. this injection will consist of either the shingrix vaccine (an injection used to prevent shingles) or a placebo (a sterile saline solution containing only salt and water that does not contain active medication).

  2. Step 2

    Observation period

    Following the injection, the monitoring period begins. during this time, the focus is on observing any potential dementia diagnosis (a condition that affects memory, thinking, and reasoning skills).

Who can join the trial?

4 criteria

  • You must be a permanent resident of Finland.
  • You must be able to follow the study rules, such as coming back for follow-up visits, which are scheduled appointments to check your health.
  • You must provide informed consent, which means you must sign a document showing that you understand the study and agree to participate before any study activities begin.
  • You must be at least 76 years old at the time you sign the agreement to join the study.

Who cannot join the trial?

9 criteria

  • You have a history of being vaccinated against Herpes Zoster (also known as shingles).
  • You have a history of dementia, which is a condition that affects memory, thinking, and reasoning, before joining the study. This includes people who have been officially diagnosed or those currently being tested for it.
  • You are currently taking, or have previously taken, medications specifically used to treat dementia.
  • You have recently undergone, or are currently undergoing, cognitive assessments (medical tests used to check how well your brain is working) because doctors suspect you might have dementia. This includes tests that are still ongoing or gave unclear results, unless it was already proven that you do not have the condition.
  • You are severely immunocompromised, which means your body's immune system (the system that helps you fight off illnesses) is very weak. This includes people with blood cancers, or those who have had a stem cell transplant or an organ transplant.
  • You are currently taking part in another clinical trial where you have received or will receive an investigational product (a medicine or treatment that is still being studied).
  • You have a known systemic hypersensitivity, which is a widespread allergic reaction, to any of the ingredients in the vaccine.
  • You have a history of a life-threatening reaction to the vaccines used in this study or to any other vaccine that contains the same ingredients.
  • You currently live in a nursing facility (a residential home for people who need constant care).
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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, it is being tested to see if it can also help reduce the risk of being diagnosed with dementia in older adults.

What is already known about the treatment

  • Shingrix

    This vaccine is administered as a liquid injection into a muscle and is currently used as a standard medical treatment to prevent shingles. It is classified as a recombinant vaccine that works by introducing a specific piece of the virus protein to teach the body's immune system how to recognize and fight the virus. By triggering this protective response, it helps prevent the reactivation of the virus that causes painful skin rashes and nerve pain.

  • Placebo

    This is a sterile saline solution made of salt and water that is administered via injection to serve as a comparison in clinical studies. It is not a medicinal drug and contains no active ingredients to treat or prevent any disease. In this trial, it is used as a control to help researchers determine if the actual vaccine produces a measurable effect.

Investigated diseases

  • Dementia

    This is a general term for a decline in mental ability severe enough to interfere with daily life. It involves the loss of cognitive functions such as memory, reasoning, and communication. The condition typically progresses gradually over time. As it develops, the damage to brain cells becomes more widespread. This leads to increasing difficulty in performing routine tasks and managing personal care.

  • Alzheimer's disease

    This is a specific type of brain disorder that causes a progressive decline in memory and thinking skills. It occurs when certain proteins build up in the brain and damage nerve cells. The condition starts with mild forgetfulness and slowly worsens over many years. As the disease advances, it affects a person's ability to recognize familiar faces and navigate their surroundings. The loss of cognitive abilities continues to grow as more brain cells are affected.

Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2025-524598-17-00Protocol code300889Estimated enrolment35 000 patientsSponsorGlaxoSmithKline Biologicals

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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