Clinical trial • Phase IV • Neurology
Recombinant varicella zoster virus glycoprotein E for Dementia|Alzheimer's disease
Phase IV trial of Recombinant varicella zoster virus glycoprotein E for Dementia|Alzheimer's disease.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Dementia|Alzheimer's disease
- Trial Stage
- Phase IV
- Drug Modality
- Vaccine|Other
Key dates
- Initial CTIS Submission Date
- 28-11-2025
- First CTIS Authorization Date
- 16-02-2026
Trial design
Randomised, arm 1 - shingrix (herpes zoster vaccine (recombinant, adjuvanted), suspension for injection; dose unit 0.5 ml per dose, two-dose regimen implied by protocol) vs arm 2 - placebo (sterile saline solution (0.9% w/v solution of nacl in water) supplied in 1.25 ml pre-filled glass syringes). exact dosing interval not specified in the ctis record.-controlled Phase IV trial across 6 sites in Finland.
- Randomised
- Yes
- Comparator
- Arm 1 - Shingrix (Herpes zoster vaccine (recombinant, adjuvanted), suspension for injection; dose unit 0.5 mL per dose, two-dose regimen implied by protocol) vs Arm 2 - Placebo (sterile saline solution (0.9% w/v solution of NaCl in water) supplied in 1.25 mL pre-filled glass syringes). Exact dosing interval not specified in the CTIS record.
- Target Sample Size
- 35000
- Trial Duration For Participant
- 1095
Eligibility
Recruits 35000 Vulnerable population not selected. Consent: "Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure." No assent procedures described..
- Vulnerable Population
- Vulnerable population not selected. Consent: "Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure." No assent procedures described.
Inclusion criteria
- {"criterion_text":"- Participants are eligible to be included in the study only if ALL of the following criteria apply: 1. Citizens living permanently in Finland, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., return for follow-up visits).\n- 2. Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.\n- 3. Age 76 years or older at the time of signing the informed consent."}
Exclusion criteria
- {"criterion_text":"- Participants will be excluded from the study if any of the following criteria apply: 1. History of vaccination against HZ\n- 2. History of dementia prior to enrolment, including confirmed cases or those under investigation. This includes: a)\tHistory of a confirmed clinical diagnosis of dementia prior to enrolment b)\tPrior or current use of medications intended to treat dementia c)\tCurrent or recent history of cognitive assessments for any memory deficit or suspected dementia before enrollment including investigations that are ongoing or were inconclusive (but not those for which dementia was conclusively ruled out); MCI on its own without any other information to indicate cognitive decline or dementia will not result in exclusion\n- 3. Severely immunocompromised individuals (i.e., those with haematological cancer or have had stem cell transplant or organ transplant)\n- 4. Concurrently participating in another clinical trial, in which the participant has been or will be exposed to an investigational product\n- 5. 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\n- 6. Living in a nursing facility"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Incident diagnosis of dementia post-first dose of Shingrix or placebo.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- 1. Incident diagnosis of dementia occurring 1 month post-second dose of Shingrix or placebo.","definition_or_measurement_approach":""}
- {"endpoint_text":"- 2. Incident diagnosis of AD post-first dose of Shingrix or placebo.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 35000
- Recruitment Window Months
- 132
- Consent Approach
- Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure. Main informed consent form available (document L1_300889_Main ICF_FIN_fin_Public) in Finnish. Consent provided by participant; no assent process described.
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 35000
Finland
- Earliest CTIS Part Ii Submission Date
- 26-01-2026
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 86
- Number Of Sites
- 6
- Number Of Participants
- 35000
Sites
- Site Name
- Suomen Rokotepiste Oy
- Contact Person Name
- Arto Palmu
- Contact Person Email
- Arto.Palmu@fvr.fi
- Site Name
- Keski-Suomen Hyvinvointialue
- Contact Person Name
- Arto Palmu
- Contact Person Email
- Arto.Palmu@fvr.fi
- Site Name
- Paeijaet-Haemeen hyvinvointialue
- Contact Person Name
- Arto Palmu
- Contact Person Email
- Arto.Palmu@fvr.fi
- Site Name
- Kymenlaakson hyvinvointialue
- Contact Person Name
- Arto Palmu
- Contact Person Email
- Arto.Palmu@fvr.fi
- Site Name
- Satakunnan hyvinvointialue
- Contact Person Name
- Arto Palmu
- Contact Person Email
- Arto.Palmu@fvr.fi
- Site Name
- FVR Suomen rokotetutkimus Oy
- Contact Person Name
- Arto Palmu
- Contact Person Email
- Arto.Palmu@fvr.fi
Sponsor
Primary sponsor
- Full Name
- GlaxoSmithKline Biologicals
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Medidata Solutions Inc.
- Responsibilities
- eCOA; sponsorDuties codes: 15, 3, 7
- Name
- PPD Global Central Labs
- Responsibilities
- Lab/central lab services (sponsorDuties code: 4)
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eCOA; sponsorDuties codes: 15, 3, 7 (15 explicitly labelled 'eCOA')","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- The Placebo used for the clinical trial is a sterile saline solution (0.9% w/v solution of NaCl in water) supplied in 1.25 mL pre-filled glass syringes.
- Modality
- Other
- Investigational Product Name
- Shingrix suspension for injection in pre filled syringe Herpes zoster vaccine (recombinant, adjuvanted)
- Active Substance
- Recombinant varicella zoster virus glycoprotein E
- Modality
- Vaccine
- Routes Of Administration
- Intramuscular injection
- Route
- Intramuscular
- Authorisation Status
- Authorised (marketing authorisation EU/1/18/1272/003)
- Starting Dose
- 0.5 mL
- Dose Levels
- 0.5 mL per dose; two-dose regimen
- Frequency
- Two-dose regimen
- Maximum Dose
- 1 mL total
- Investigational Product Name
- Shingrix powder and suspension for suspension for injection Herpes zoster vaccine (recombinant, adjuvanted)
- Active Substance
- Recombinant varicella zoster virus glycoprotein E
- Modality
- Vaccine
- Routes Of Administration
- Intramuscular injection
- Route
- Intramuscular
- Authorisation Status
- Authorised (marketing authorisation EU/1/18/1272/002)
- Starting Dose
- 0.5 mL
- Dose Levels
- 0.5 mL per dose; two-dose regimen
- Frequency
- Two-dose regimen
- Maximum Dose
- 1 mL total
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