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Not yet recruitingNCT07872046Updated Oct 13, 2026

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 interventional study of RZV vaccine and Placebo in Cardiovascular Disease, sponsored by GlaxoSmithKline. Not yet recruiting. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
16,390
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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. Participants will be randomized to receive either RZV or placebo.

02

Conditions studied

  • Cardiovascular Disease

Keywords

  • Cardiovascular disease
  • Cardiovascular risk factors
  • Major adverse cardiovascular events
  • Public health
  • Recombinant zoster vaccine
03

In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

This study's planned enrollment of 16,390 is above the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Browse GlaxoSmithKline studies →

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 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

    o Participants with established CVD, including >=1 of the following:

    1. Coronary artery disease.
    2. Peripheral artery disease.
    3. 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.

Exclusion criteria

Exclusion Criteria:

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.
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
16,390 participants (estimated)

Study arms

  • Experimental
    RZV Group

    Participants receive 2 doses of RZV vaccine, the first dose being administered at Day 1 and the second dose at Month 2.

    Combination Product: RZV vaccine

  • Placebo comparator
    Placebo Group

    Participants receive 2 doses of placebo, the first dose being administered at Day 1 and the second dose at Month 2.

    Combination Product: Placebo

Interventions

  • Combination productRZV vaccine

    RZV vaccine will be administered intramuscularly.

    Also known as: Shingrix

  • Combination productPlacebo

    Placebo will be administered intramuscularly.

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

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

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

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

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

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

  7. Time to first occurrence of hospitalization for UA

    Time frame: 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.

    Time frame: From Day 1 to Month 14

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

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

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

    Time frame: 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.

    Time frame: 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.

    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 reachedSimilar 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 Nov 2026; primary completion for Nov 2032, 71 months later.

Of 49 industry-sponsored phase 3 interventional studies under Cardiovascular Diseases, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 83. This study's planned 71 months is above that.

Counting every sponsor, half of 85 studies reached it within 57 months; a quarter within 30 and three quarters within 83.

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

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

Registered
Oct 7, 2026
First posted
Oct 13, 2026
StartEst.
Nov 30, 2026
Primary completionEst.
Nov 25, 2032
CompletionEst.
Nov 25, 2032
Last update
Oct 13, 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.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

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
NCT07872046
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
Nov 25, 2032 (estimated)
Completion
Nov 25, 2032 (estimated)
Last update
Oct 13, 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
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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