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New treatment option for Herpes Zoster
Official title A Study to Evaluate the Effect of Recombinant Zoster Vaccine on New Diagnosis of Dementia in an Older Adult Population Aged 76 Years or Older in Finland
ClinicalTrials.gov ID: NCT07502560
What this study is testing
What is Recombinant zoster vaccine?
Recombinant zoster vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for herpes zoster.
Also referred to as Shingrix.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the effect of the recombinant zoster vaccine on the risk of new diagnosis of dementia among adults aged 76 years or older in Finland. Participants will be enrolled and randomized in a 3:1 ratio to receive either recombinant zoster vaccine or placebo.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 76 and older. Healthy volunteers may be eligible.
You may be able to join if
- Citizens living permanently in Finland, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure. Informed consent will...
- Age 76 years or older at the time of signing the informed consent.
You likely can't join if
- Prior receipt of a Herpes Zoster (HZ) vaccine.
- History of dementia diagnosis prior to enrolment, including confirmed cases or those under investigation. This includes:
- History of a confirmed clinical diagnosis of dementia prior to enrolment.
- Prior or current use of medications intended to treat dementia.
- Current or recent history of cognitive assessments for any memory deficit or suspected dementia before enrolment including investigations that are...
- Severely immunocompromised individuals.
See the full eligibility criteria
- Citizens living permanently in Finland, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure. Informed consent will include consent to access health register data for participants.
- Age 76 years or older at the time of signing the informed consent.
- Prior receipt of a Herpes Zoster (HZ) vaccine.
- History of dementia diagnosis prior to enrolment, including confirmed cases or those under investigation. This includes:
- History of a confirmed clinical diagnosis of dementia prior to enrolment.
- Prior or current use of medications intended to treat dementia.
- Current or recent history of cognitive assessments for any memory deficit or suspected dementia before enrolment including investigations that are ongoing or that were inconclusive (but not those for which dementia was...
- Severely immunocompromised individuals.
- Concurrently participating in another clinical trial, in which the participant has been or will be exposed to an investigational product or ongoing participation in trials focused on preventive dementia interventions.
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
- Living in a nursing facility.
The study team makes the final eligibility decision.
Where it's taking place
- Espoo, Finland
- Helsinki, Finland
- Jarvenpaa, Finland
- Kokkola, Finland
- Oulu, Finland
- Seinäjoki, Finland
- Tampere, Finland
- Turku, Finland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 76 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Espoo, Finland; Helsinki, Finland; Jarvenpaa, Finland; Kokkola, Finland; Oulu, Finland; Seinäjoki, Finland and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.