A Study Exploring the Effect of Adjuvanted RZV or RSVPreF3 Vaccines on Coronary Plaque Progressio… (NCT07712380) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study Exploring the Effect of Adjuvanted RZV or RSVPreF3 Vaccines on Coronary Plaque Progression in Adults >=50 Years of Age at Risk for Cardiovascular Events
450 participantsStarted 2026-08-31
Plain-language summary
This study is designed to evaluate whether the adjuvanted recombinant zoster vaccine (RZV) or the adjuvanted respiratory syncytial virus PreFusion protein 3 (RSVPreF3) vaccine can attenuate the progression of coronary plaque in adult individuals at risk for cardiovascular events.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants, including participants with a caregiver 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.
* Medically stable patients as established by medical history and clinical examination at screening.
* Male or female participants \>=50 years of age (YOA) at the time of the first study intervention administration.
* Participants with documented history of coronary artery calcium (CAC) and two or more risk factors for cardiovascular disease.
* Participants with estimate glomerular filtration rate (eGFR) \>=45 mL/min/1.73m\^2.
* Participants who can undergo serial CCTA.
* Participants with no planned changes in medical therapies through the course of the study.
* Participants of non-childbearing potential may be enrolled in the clinical study.
* Participant of childbearing potential may be enrolled in the study if the participant:
* has practiced adequate contraception for at least 30 days prior to study intervention administration, and
* has a negative pregnancy test within 24 hours prior to the study intervention administration and prior to each CCTA, and
* has agreed to continue adequate contraception during the entire duration of the study and for 8 weeks after completion of the study.
Exclusion Criteria:
Cardiovascular conditions
* Prior atherosclerotic cardiovascul…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in total coronary non-calcified plaque volume (NCPV) as measured on coronary computed tomography angiography (CCTA)