Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorTor Biering-Sørensen
About this trial
DAN-ZOSTER is a nationwide randomized study investigating whether vaccination against herpes zoster (shingles) can reduce the risk of cardiovascular disease and dementia in older adults. Herpes zoster is caused by reactivation of the varicella-zoster virus and becomes more common with increasing age. Some observational studies have suggested that vaccination against herpes zoster may also lower the risk of heart attacks, strokes, and dementia, but this has not been confirmed in randomized clinical trials.
In this study, approximately 162,000 adults aged 65 years or older living in Denmark will be randomly assigned to either receive the recombinant herpes zoster vaccine (Shingrix®) or receive no vaccine. Participants in the vaccine group will receive two doses given 2-6 months apart.
Participants will be identified and invited using Danish national registries and digital mail systems. Information about health outcomes will be collected through nationwide health registries during follow-up.
The main outcomes of the study are major cardiovascular events (heart attack, stroke, or cardiovascular death) and new diagnoses of dementia. The goal of the study is to determine whether herpes zoster vaccination can help prevent these conditions in older adults.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 65 years and above at the time of consent
Self-reported ability to understand written and spoken Danish or English
Informed consent form has been signed and dated
Disqualifiers
A prior diagnosis of dementia
Chronic inflammatory rheumatic disease and concomitant immunosuppressive therapy
Prior herpes zoster vaccination
Trial design
Design model
Parallel
Treatments tested in this trial
Recombinant Herpes Zoster Vaccine (Shingrix)
Biological/VaccineTwo doses of Shingrix vaccine spaced 2-6 months apart.
Treatment groups
162,000 Participants
are divided into 2 treatment groupsGroup A: Recombinant Herpes Zoster Vaccine (Shingrix).Experimental treatment 1 intervention
Group B: No Herpes Zoster vaccine (control)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Hospitalization for MACE
Defined as a composite of non-fatal myocardial infarction, non-fatal stroke and cardiovascular death
Time frame
From the first of the two initially booked study visits up to approximately 1 year2
New dementia
Defined as a composite of Alzheimer's dementia, vascular dementia and unspecified dementia
Time frame
From the first of the two initially booked study visits up to approximately 3 yearsSecondary outcomes
1
Hospitalization for non-fatal acute coronary syndrome, non-fatal stroke, or cardiovascular death
Defined as a composite of acute coronary syndrome, stroke and cardiovascular death Any I-diagnosis as cause of death
Time frame
From the first of the two initially booked study visits up to approximately 1 year2
Hospitalization for any cardiovascular disease
Time frame
From the first of the two initially booked study visits up to approximately 1 year3
Hospitalization for stroke
Time frame
From the first of the two initially booked study visits up to approximately 1 year4
Hospitalization for myocardial infarction
Time frame
From the first of the two initially booked study visits up to approximately 1 yearOther outcomes
1
Hospitalization for unstable angina
Time frame
From the first of the two initially booked study visits up to approximately 3 years2
Acute and/or elective coronary revascularization
Time frame
From the first of the two initially booked study visits up to approximately 3 years3
Hospitalization for heart failure
Time frame
From the first of the two initially booked study visits up to approximately 3 years4
Hospitalization for pulmonary embolism
Time frame
From the first of the two initially booked study visits up to approximately 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tor Biering-Sørensen
Lead sponsor
Herlev and Gentofte Hospital
Sponsor institution
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov