ClinicalTrials.gg
Not yet recruitingNCT07712380Updated Oct 20, 2026

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 interventional study of Placebo and Adjuvanted RZV vaccine in Cardiovascular Disease, sponsored by GlaxoSmithKline. Not yet recruiting. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Updated Oct 20, 2026Start date movedPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiovascular Disease

Keywords

  • Adjuvanted Recombinant zoster vaccine
  • Adjuvanted RSVPreF3 vaccine
  • Herpes Zoster
  • Respiratory syncytial virus
  • RSV
  • Coronary plaque
  • Cardiovascular disease
03

In context

Cardiovascular Diseases

5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.

This study's planned enrollment of 450 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 (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- may be enrolled in the clinical study.
  • Participant of childbearing potential may be enrolled in the study if the participant:

    • has practiced adequate 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

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 and/or unstable heart failure at the screening visit.

Other medical conditions

  • History of any reaction or likely to be exacerbated by any component of the study intervention(s).
  • Any confirmed or suspected or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Acute or unstable chronic conditions, 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 \<=5 years, radiation therapy or systemic therapy prior to signing .
  • Any history of dementia or any medical condition that moderately or severely impairs cognition.

Prior/Concomitant therapy

  • Previous vaccination against Herpes Zoster (HZ) ( 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.
  • 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.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
450 participants (estimated)

Study arms

  • Placebo comparator
    Placebo group

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

    Combination Product: Placebo

  • Experimental
    Adjuvanted RZV group

    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

  • Experimental
    Adjuvanted RSVPreF3 group

    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

  • Combination productPlacebo

    Placebo will be administered intramuscularly.

  • Combination productAdjuvanted RZV vaccine

    Adjuvanted RZV vaccine will be administered intramuscularly.

  • BiologicalAdjuvanted RSVPreF3 vaccine

    Adjuvanted RSVPreF3 vaccine will be administered intramuscularly.

06

What researchers measure

Primary outcomes

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

    Time frame: At Baseline (Day 1) and at Month 14

Secondary outcomes

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

    Time frame: At Baseline (Day 1) and at Month 14

  2. Change from Baseline in low attenuation plaque as measured on CCTA

    Time frame: At Baseline (Day 1) and at Month 14

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

    Time frame: At Baseline (Day 1) and at Month 14

  4. 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.

    Time frame: From Day 1 to Month 15

  5. Number of participants with SAEs related to study participation or study procedures

    Time frame: From start of screening (Day -15) to Month 15

  6. Number of participants with SAEs leading to withdrawal from the study

    Time frame: From Day 1 to Month 15

  7. 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.

    Time frame: From Day 1 to Month 14

  8. 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.

    Time frame: From Day 1 to Month 14

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

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.

Data sharing details ↗ · www.gsk-studyregister.com

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for May 2029, 30 months later.

Of 84 phase 2 interventional studies under Cardiovascular Diseases, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 59. This study's planned 30 months is close to that.

Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, on Oct 20, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2026
First posted
Jul 17, 2026
StartEst.
Oct 23, 2026was Aug 2026
Primary completionEst.
May 2, 2029
CompletionEst.
May 2, 2029
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Aug 31, 2026→Oct 23, 2026
Oct 20, 2026
Primary completion
May 4, 2029→May 2, 2029
Oct 20, 2026
Study completion
May 4, 2029→May 2, 2029
Oct 20, 2026
Secondary outcomes
2 added
What changed in the outcomes
  • AddedNumber of participants with any medically-attended adverse events (MAAEs)Time frame: From Day 1 to Month 14
  • AddedNumber of participants with any potential immune-mediated disorders (pIMDs)Time frame: From Day 1 to Month 14
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Start date Aug 31, 2026→Oct 23, 2026
    Primary completion May 4, 2029→May 2, 2029
    Study completion May 4, 2029→May 2, 2029
    Secondary outcomes 2 added
    What changed in the outcomes
    • AddedNumber of participants with any medically-attended adverse events (MAAEs)Time frame: From Day 1 to Month 14
    • AddedNumber of participants with any potential immune-mediated disorders (pIMDs)Time frame: From Day 1 to Month 14
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07712380
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 17, 2026
Start date
Oct 23, 2026 (estimated)
Primary completion
May 2, 2029 (estimated)
Completion
May 2, 2029 (estimated)
Last update
Oct 20, 2026

Study contacts

US GSK Clinical Trials Call Center
Contact
GSKClinicalSupportHD@gsk.com
877-379-3718
EU GSK Clinical Trials Call Center
Contact
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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