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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT07712380

Run by

GlaxoSmithKline

People needed

450

Starts

2026-08-31

Expected to finish

2029-05-04

Last updated by the study team

2026-07-17

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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