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

NCT07712380 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 309767
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiovascular Disease

Keywords

Adjuvanted Recombinant zoster vaccine; Adjuvanted RSVPreF3 vaccine; Herpes Zoster; Respiratory syncytial virus; RSV; Coronary plaque; Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in total coronary non-calcified plaque volume (NCPV) as measured on coronary computed tomography angiography (CCTA)

  At Baseline (Day 1) and at Month 14

Secondary Outcomes (6)

• Change from Baseline in total coronary plaque volume as measured on CCTA

  At Baseline (Day 1) and at Month 14

• Change from Baseline in low attenuation plaque as measured on CCTA

  At Baseline (Day 1) and at Month 14

• Change from Baseline in peri-coronary fat attenuation index as measured on CCTA

  At Baseline (Day 1) and at Month 14

• Number of participants with any serious adverse events (SAEs)

  From Day 1 to Month 15

• Number of participants with SAEs related to study participation or study procedures

  From start of screening (Day -15) to Month 15

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Participants in this group receive placebo, the first dose being administered at Day 1 and the second dose at Month 2.

Combination Product: Placebo

Adjuvanted RZV group

EXPERIMENTAL

Participants in this group receive the adjuvanted RZV vaccine, the first dose being administered at Day 1 and the second dose at Month 2.

Combination Product: Adjuvanted RZV vaccine

Adjuvanted RSVPreF3 group

EXPERIMENTAL

Participants in this group receive a single dose of placebo at Day 1 and a single dose of the adjuvanted RSVPreF3 vaccine at Month 2.

Combination Product: Placebo; Biological: Adjuvanted RSVPreF3 vaccine

Interventions

Placebo COMBINATION_PRODUCT

Placebo will be administered intramuscularly.

Adjuvanted RSVPreF3 group; Placebo group

Adjuvanted RSVPreF3 vaccine BIOLOGICAL

Adjuvanted RSVPreF3 vaccine will be administered intramuscularly.

Adjuvanted RSVPreF3 group

Adjuvanted RZV vaccine COMBINATION_PRODUCT

Adjuvanted RZV vaccine will be administered intramuscularly.

Adjuvanted RZV group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Cardiovascular Diseases; Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will be conducted in an observer-blind manner.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): May 4, 2029
• Study Completion (Estimated): May 4, 2029
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.