Could a vaccine protect your heart? study tests shingles and RSV shots against artery plaque

NCT ID NCT07712380

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study investigates whether two common vaccines—the shingles vaccine (RZV) and an RSV vaccine (RSVPreF3)—can slow the buildup of fatty plaque in the coronary arteries. The trial enrolls adults aged 50 and older who are at risk for cardiovascular events. Participants receive either one of the vaccines or a placebo, and changes in plaque volume are measured using CT scans over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
adjuvanted recombinant zoster vaccine (RZV) or adjuvanted respiratory syncytial virus PreFusion protein 3 (RSVPreF3) vaccine
What this could lead to
If successful, this could show that common vaccines have an unexpected benefit: slowing the progression of artery plaque and reducing heart attack risk.
What could go wrong
This is an early exploratory study, so the vaccines may have no effect on plaque. Also, any benefit would be modest and not a replacement for standard heart treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 cardiovascular disease (ASCVD) event. * History or planned coronary artery bypass grafting (CABG), any cardiovascular surgery, percutaneous coronary intervention (PCI), or valvular intervention. * Heart failure with Class III or IV symptoms according to the New York Heart Association and/or unstable heart failure at the screening visit. Other medical conditions * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Acute or unstable chronic conditions, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and/or laboratory screening tests. * Recurrent history or uncontrolled neurological disorders or any neuroinflammatory, congenital neurological conditions, encephalopathies, or seizures. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study. * Condition that in the judgment of the investigator would make intramuscular injection unsafe. * Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. * History of malignancy \<=5 years, radiation therapy or systemic therapy prior to signing informed consent. * Any history of dementia or any medical condition that moderately or severely impairs cognition. Prior/Concomitant therapy * Previous vaccination against Herpes Zoster (HZ) (investigational or licensed vaccine) and/or planned administration of vaccination against HZ during the study period other than the vaccine administered during the study. * Previous vaccination with an RSV vaccine (investigational or licensed vaccine) and/or planned administration of an RSV vaccine during the study period other than the adjuvanted RSVPreF3 vaccine administered during the study. * Use of any investigational or non-registered product other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) (Day -29 to Day 1), or their planned use during the study period. * Administration of immunoglobulins or other blood products or plasma derivatives during the period starting 90 days before the study intervention or planned administration during the study period. * Chronic administration of immune-modifying drugs and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. * Planned administration/administration of a vaccine in the period starting 30 days before the first dose/each dose and ending 30 days after the last dose/each dose of study intervention(s) administration, with the exception of SARS-CoV-2 and inactivated seasonal influenza (flu) vaccine which can be administered up to 14 days before or 14 days after study intervention administration. Prior/Concurrent clinical study participation * Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention drug/invasive medical device. * Contraindications to CCTA. Other exclusion criteria * Bedridden participants. * Pregnant or lactating participant. * History of current chronic alcohol consumption and/or drug abuse, based on investigator's judgment. * Any study personnel or their immediate dependents, family, or household members.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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  2. A doctor treating you

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