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.
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
- Type of treatment
- Vaccines, Injection or infusion
- 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
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.
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.
- Conditions
- Cardiovascular Disease
- 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 group | Role | What they receive |
|---|---|---|
| RZV Group | Experimental | Participants 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 Group | Placebo comparator | Participants 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.
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)
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)
Time to first occurrence of MI (fatal and non-fatal)
Measured: From Day 1 to total follow-up time (up to Month 74)
Time to first occurrence of stroke (fatal and non-fatal)
Measured: From Day 1 to total follow-up time (up to Month 74)
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)
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)
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)
Time to first occurrence of hospitalization for UA
Measured: From Day 1 to total follow-up time (up to Month 74)
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
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)
Number of participants reporting SAEs leading to withdrawal from the study
Measured: From Day 1 to total follow up time (up to Month 74)
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
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.
- First posted13 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion25 Nov 2032 (estimated)
- Study completion25 Nov 2032 (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 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)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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