Cardiovascular DiseasePhase 2NCT07712380
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
A Phase 2 study testing Adjuvanted RZV vaccine and Adjuvanted RSVPreF3 vaccine in people with Cardiovascular Disease, run by GlaxoSmithKline.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Adjuvanted RZV vaccine and Adjuvanted RSVPreF3 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2026to 2 May 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Observer-blind, Placebo-controlled Exploratory Study to Evaluate Whether Administration of Adjuvanted RZV or RSVPreF3 Vaccine Can Attenuate Coronary Plaque Progression in Individuals 50 Years of Age and Above Who Are at Risk for Cardiovascular Events
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
- Being tested
- Placebo, Adjuvanted RZV vaccine, Adjuvanted RSVPreF3 vaccine
- Keywords
- Adjuvanted Recombinant zoster vaccine, Adjuvanted RSVPreF3 vaccine, Herpes Zoster, Respiratory syncytial virus, RSV, Coronary plaque, Cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboCombination product
Placebo will be administered intramuscularly.
Adjuvanted RZV vaccineCombination product
Adjuvanted RZV vaccine will be administered intramuscularly.
Adjuvanted RSVPreF3 vaccineBiological
Adjuvanted RSVPreF3 vaccine will be administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Combination Product: Placebo; Biological: Adjuvanted RSVPreF3 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in total coronary non-calcified plaque volume (NCPV) as measured on coronary computed tomography angiography (CCTA)
Measured: At Baseline (Day 1) and at Month 14
Secondary outcomes (8)
Change from Baseline in total coronary plaque volume as measured on CCTA
Measured: At Baseline (Day 1) and at Month 14
Change from Baseline in low attenuation plaque as measured on CCTA
Measured: At Baseline (Day 1) and at Month 14
Change from Baseline in peri-coronary fat attenuation index as measured on CCTA
Measured: At Baseline (Day 1) and at Month 14
Number of participants with any serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination.
Measured: From Day 1 to Month 15
Number of participants with SAEs related to study participation or study procedures
Measured: From start of screening (Day -15) to Month 15
Number of participants with SAEs leading to withdrawal from the study
Measured: From Day 1 to Month 15
Number of participants with any medically-attended adverse events (MAAEs)
MAAEs are events for which the participant received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason, other than routine health care visits.
Measured: From Day 1 to Month 14
Number of participants with any potential immune-mediated disorders (pIMDs)
pIMDs are a subset of adverse events of special interest (AESIs) that include autoimmune disorders and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Measured: From Day 1 to Month 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start23 Oct 2026 (estimated)
- Primary completion2 May 2029 (estimated)
- Study completion2 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712380
- Sponsor's protocol ID
- 309767
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf