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Cardiovascular DiseasePhase 3NCT07872046

A Study on the Impact of Recombinant Zoster Vaccine on Major Adverse Cardiovascular Events in Adults >=50 Years of Age With Established Cardiovascular Disease or With >=2 Cardiovascular Risk Factors

A Phase 3 study testing RZV vaccine in people with Cardiovascular Disease, run by GlaxoSmithKline.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to evaluate the effect of the recombinant zoster vaccine (RZV) on the occurrence of clinically important cardiovascular (heart and blood vessel) events, with a focus on major adverse cardiovascular events (MACE), in adults with established cardiovascular disease (CVD) or with 2 or more CV risk factors. 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?
RZV vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16,390 participants
Where
No sites listed yet
Study dates
30 Nov 2026to 25 Nov 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

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, and medically managed with standard of care (SOC) pharmacotherapy according to local clinical practice for:
  • Two or more risk factors for CVD, OR
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  • o Participants with established CVD, including >=1 of the following:
  • Coronary artery disease.
  • Peripheral artery disease.
  • Cerebrovascular disease.
  • Participants of non-childbearing potential may be enrolled in the clinical study.
  • Participant of childbearing potential (POCBP) 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
  • has agreed to continue adequate contraception during the entire treatment period and for 8 weeks after completion of the study intervention administration series.

Who cannot join

  • Cardiovascular conditions • Prior CVD event or hospitalization for UA within 3 months of the screening visit or CVD expected to require surgical intervention within 6 months after vaccine administration.
  • 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).
  • Uncontrolled or unstable chronic conditions including New York Heart Association (NYHA) Class IV heart failure, clinically significant pulmonary, CV, hepatic, or renal functional abnormality, as determined by medical history and clinical examination.
  • Recurrent history or uncontrolled neurological disorders or any neuroinflammatory, congenital neurological conditions, encephalopathies, or seizures.
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  • 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 prior to signing informed consent.
  • Prior/Concomitant therapy
  • Previous vaccination against 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.
  • 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 (defined as more than 14 consecutive days in total) 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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine which can be administered up to 14 days before or 14 days after study intervention administration. Inactivated seasonal influenza vaccines can be co-administered or administered at any time.
  • 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.
  • Other exclusion criteria
  • Bedridden participants.
  • Pregnant or lactating participant.
  • Current/history of alcohol or substance use disorder, 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.

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

About this study

Official title: A Phase 3a Observer-blind, Randomized, Placebo-controlled, Multi-country Study to Evaluate the Impact of Recombinant Zoster Vaccine on Major Adverse Cardiovascular Events in Adults >=50 Years of Age With Established Cardiovascular Disease or With >=2 Cardiovascular Risk Factors

This study aims to evaluate the effect of the recombinant zoster vaccine (RZV) on the occurrence of clinically important cardiovascular (heart and blood vessel) events, with a focus on major adverse cardiovascular events (MACE), in adults with established cardiovascular disease (CVD) or with 2 or more CV risk factors. Participants will be randomized to receive either RZV or placebo.

Being tested
RZV vaccine, Placebo
Keywords
Cardiovascular disease, Cardiovascular risk factors, Major adverse cardiovascular events, Public health, Recombinant zoster vaccine
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RZV vaccineCombination product

    Also called Shingrix

    RZV vaccine will be administered intramuscularly.

  • PlaceboCombination product

    Placebo will be administered intramuscularly.

Study groups in NCT07872046
Study groupRoleWhat they receive
RZV GroupExperimentalParticipants receive 2 doses of RZV vaccine, the first dose being administered at Day 1 and the second dose at Month 2.
Receives: Combination Product: RZV vaccine
Placebo GroupPlacebo comparatorParticipants receive 2 doses of placebo, the first dose being administered at Day 1 and the second dose at Month 2.
Receives: Combination Product: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first occurrence of composite 3-point (3P)-MACE

    3P-MACE is defined as a confirmed composite endpoint consisting of non-fatal myocardial infarction (MI), non-fatal stroke or cardiovascular (CV) death.

    Measured: From Day 1 to total follow-up time (up to Month 74)

Secondary outcomes (12)

  1. Time to first occurrence of composite 5-point (5P)-MACE

    5P-MACE is defined as a confirmed composite endpoint consisting of non-fatal MI, non-fatal stroke, hospitalization for unstable angina (UA), hospitalization for heart failure (HF) or CV death.

    Measured: From Day 1 to total follow-up time (up to Month 74)

  2. Time to first occurrence of MI (fatal and non-fatal)

    Measured: From Day 1 to total follow-up time (up to Month 74)

  3. Time to first occurrence of stroke (fatal and non-fatal)

    Measured: From Day 1 to total follow-up time (up to Month 74)

  4. Time to occurrence of CV death

    CV death is defined as death due to CV events.

    Measured: From Day 1 to total follow-up time (up to Month 74)

  5. Time to occurrence of all-cause death

    All-cause death is defined as all deaths due to any cause.

    Measured: From Day 1 to total follow-up time (up to Month 74)

  6. Time to first occurrence of hospitalization for HF or death due to HF

    Measured: From Day 1 to total follow-up time (up to Month 74)

  7. Time to first occurrence of hospitalization for UA

    Measured: From Day 1 to total follow-up time (up to Month 74)

  8. Number of participants reporting 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 14

  9. Number of participants reporting SAEs related to the study intervention or study procedures

    Measured: From Day 1 to total follow up time (up to Month 74)

  10. Number of participants reporting SAEs leading to withdrawal from the study

    Measured: From Day 1 to total follow up time (up to Month 74)

  11. Number of participants reporting any medically-attended adverse events (MAAEs)

    MAAEs are adverse events for which participants received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason, other than routine health care visits. Any = occurrence of the MAAEs regardless of intensity grade or relation to the study vaccination.

    Measured: From Day 1 to Month 14

  12. Number of participants reporting any adverse events of special interest (AESIs)

    AESIs include potential immune-mediated disorders (pIMDs). Any = occurrence of the AESIs regardless of intensity grade or relation to the study vaccination.

    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.

  1. First posted13 Oct 2026
  2. Study start30 Nov 2026 (estimated)
  3. Primary completion25 Nov 2032 (estimated)
  4. Study completion25 Nov 2032 (estimated)

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
16,390 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07872046
Sponsor's protocol ID
309768
Other IDs
2026-527478-35-00
Status last verified
Oct 2026
First submitted
7 Oct 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RZV vaccine in people with Cardiovascular Disease, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first occurrence of composite 3-point (3P)-MACE (time frame: From Day 1 to total follow-up time (up to Month 74)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07872046.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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